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46 Transplant Reaction Trials Near You
Power is an online platform that helps thousands of Transplant Reaction patients discover FDA-reviewed trials every day. Every trial we feature meets safety and ethical standards, giving patients an easy way to discover promising new treatments in the research stage.
Learn More About PowerBudesonide for Engraftment Syndrome After Stem Cell Transplant
Detroit, Michigan
The purpose of this study is to determine if budesonide prophylaxis starting day 5 after transplant reduces engraftment fever in autologous and allogeneic stem cell transplant recipients.
No Placebo Group
Prior Safety Data
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Other Trials, Non-hematologic Malignancies
110 Participants Needed
SYN-004 for Post-Bone Marrow Transplant Complications
Saint Louis, Missouri
Study Objectives:
1. To evaluate the safety and tolerability of oral SYN-004 in adult allogeneic HCT (allo-HCT) recipients who develop fever after conditioning therapy and are treated with IV β-lactam antibiotics meropenem (MER), piperacillin tazobactam (PIP/TAZO), or cefepime (FEP).
2. To evaluate potential absorption of oral SYN-004 into the systemic circulation of allo-HCT recipients and potential SYN-004-mediated alterations to systemic levels and efficacy of IV MER, PIP/TAZO or FEP.
3. To evaluate potential protective effects of SYN-004 on the intestinal microbiome of allo-HCT recipients treated with IV MER, PIP/TAZO or FEP.
4. To obtain preliminary information on potential therapeutic benefits and patient outcomes of SYN-004 in allo-HCT recipients treated with IV MER, PIP/TAZO or FEP
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Allergies, Other Studies, Liver Issues, Others
Must Be Taking:Beta-lactam Antibiotics
36 Participants Needed
Extended-Release Tacrolimus for Liver Transplant Complications
Edmonton, Alberta
Medications used after transplant to prevent rejection are associated with many side effects. Tacrolimus side effects include kidney dysfunction; tremor, headaches, difficulty sleeping, change in sensation (legs), seizure, or confusion; high blood pressure; anemia, or low blood cell counts; diabetes; abnormal cholesterol and weight gain. The investigators want to use a new, approved, formulation of the standard medication (Envarsus) as they believe it may be associated with reduced side effects. The investigators would like to assess how safe it is to use this medication and how well it works in comparison to currently used formulations. The investigators will study if there are less side effects and will study clinical outcomes (including how well the liver does and if there is need for hospitalizations after transplant).
The investigators hope that this information will improve the care provided to and outcomes in patients following liver transplant.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Congenital Long QT Syndrome, Chronic Kidney Disease, Others
Must Be Taking:Calcineurin Inhibitors
94 Participants Needed
Belumosudil for Lung Transplant Rejection
Columbus, Ohio
This double-blind, randomized, placebo-controlled, multinational, multicenter, parallel-group, Phase 3, 2-arm, study will investigate the efficacy and safety of belumosudil compared with placebo, both administered on top of azithromycin and standard-of-care regimen of immunosuppression in male or female participants at least 1 year after bilateral lung transplant, who are at least 18 years of age and who have evidence of progressive CLAD despite azithromycin therapy.
Study details include:
The study duration will be up to 31 weeks for participants not entering the open-label extension (OLE) period and up to 57 weeks for participants entering the OLE period but not the long-term OLE.
The treatment duration will be up to 26 weeks for participants not entering the OLE period and up to 52 weeks for participants entering the OLE period but not the long-term OLE.
The number of visits will be up to 10 visits for participants not entering the OLE period and up to 16 visits for participants entering the OLE period but not the long-term OLE.
For participants who enter the long-term OLE, treatment and study participation will continue with visits every 12 weeks per protocol specifications.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Lung Function Decline, Others
Must Be Taking:Azithromycin
180 Participants Needed
Tabelecleucel for Post-Transplant Cancer
Columbus, Ohio
The purpose of this study is to determine the clinical benefit and characterize the safety profile of tabelecleucel for the treatment of Epstein-Barr virus-associated post-transplant lymphoproliferative disease (EBV+ PTLD) in the setting of (1) solid organ transplant (SOT) after failure of rituximab (SOT-R) and rituximab plus chemotherapy (SOT-R+C) or (2) allogeneic hematopoietic cell transplant (HCT) after failure of rituximab.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:Burkitt Lymphoma, Hodgkin Lymphoma, Others
Must Not Be Taking:Daily Steroids, Methotrexate
66 Participants Needed
Tabelecleucel for EBV Associated Diseases
Columbus, Ohio
This trial tests tabelecleucel, a treatment using special immune cells, in patients with certain diseases related to the Epstein-Barr virus (EBV) who can't use or don't respond to standard treatments. It works by enhancing the immune system's ability to attack virus-infected cells. Tabelecleucel is being tested for recurring or hard-to-treat EBV-related diseases.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Active Infections, HIV, GvHD, Others
Must Not Be Taking:Daily Steroids, Methotrexate
190 Participants Needed
Felzartamab for Antibody Mediated Rejection
Columbus, Ohio
The main goal of this trial is to evaluate the efficacy of felzartamab compared to placebo in kidney transplant recipients diagnosed with late active or chronic active AMR.
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Key Eligibility Criteria
Disqualifiers:ABO-incompatible Transplant, Multiple Organ Transplants, Others
Must Not Be Taking:Immunoglobulins, Complement Inhibitors
120 Participants Needed
Carfilzomib + Belatacept for Kidney Transplant Rejection
Cincinnati, Ohio
The purpose of this study is to see:
1. If using these two drugs (carfilzomib and belatacept) together is safe
2. If the use of these two study drugs in addition to the usual immunosuppression for kidney transplant patients can improve your transplanted kidney function by lowering the antibodies you have against your transplanted kidney
3. If the study drugs effect the immune cells that were responding to your donor kidney. And, whether blood or urine tests can measure signs of inflammation and kidney cell injury
4. If using new computer techniques can help describe important changes seen on biopsy in your donated kidneys
The primary objective is to assess the efficacy of carfilzomib and belatacept therapy when added to current treatment with steroids and maintenance immunosuppression, compared to conventional treatment alone, to improve the clinical outcome of renal transplant patients with active and chronic - active ABMR occurring more than 6 months after renal transplantation or less than 6 months post-transplant with persistent refractory Antibody-Mediated Rejection (ABMR)
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Cancer, HIV, Hepatitis, Others
Must Be Taking:Steroids, Immunosuppressants
100 Participants Needed
Tegoprubart for Kidney Transplant Rejection
Cincinnati, Ohio
This study will evaluate the long term safety and efficacy of AT-1501 (tegoprubart) compared with tacrolimus in patients undergoing kidney transplantation.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnant, Breastfeeding, Others
132 Participants Needed
Tegoprubart for Kidney Transplant Rejection
Cincinnati, Ohio
This study will evaluate the safety and efficacy of AT-1501 compared with tacrolimus in patients undergoing kidney transplantation.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
120 Participants Needed
Belatacept Regimen for Kidney Transplant Recipients
Cincinnati, Ohio
The purpose of this study is to evaluate the benefits and risks of conversion of existing adolescent kidney allograft recipients aged 12 to less than 18 years of age to a belatacept-based immunosuppressive regimen as compared to continuation of a calcineurin inhibitor-based regimen and their adherence to immunosuppressive medications.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 3
Age:12 - 17
Key Eligibility Criteria
Disqualifiers:EBV Negative, Acute Rejection, TB, Others
Must Be Taking:Calcineurin Inhibitors
102 Participants Needed
Belumosudil for Lung Transplant
Cincinnati, Ohio
The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study. Belumosudil is an investigational drug that blocks a molecule in the body that reduces inflammation and scarring and may play a role in the development and progression of CLAD. Belumosudil is a drug approved by the FDA to treat adults and children 12 years and older with chronic graft-versus-host disease (cGVHD), a condition with some similarities to CLAD.
The primary objective it to determine the efficacy of treatment with Belumosudil + maintenance immunosuppression (IS) versus placebo + maintenance IS on preventing the subsequent development of probable or definite CLAD, lung retransplant, or death.
Prior Safety Data
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:12+
Key Eligibility Criteria
Disqualifiers:Multi-organ Transplants, HIV, Hepatitis B, Others
Must Be Taking:Calcineurin Inhibitors
234 Participants Needed
ALXN2030 for Rejection After Kidney Transplant
Cincinnati, Ohio
The primary objective of this study is to evaluate the efficacy of ALXN2030 compared with placebo on biopsy proven histologic resolution in participants with active or chronic active antibody-mediated rejection (AMR) at Week 52.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:HIV, Hepatitis B/C, Liver Disease, Others
Must Not Be Taking:Antiretrovirals, Hepatitis Treatments
45 Participants Needed
AT-1501 for Kidney Transplant
Cincinnati, Ohio
This study will evaluate the safety, PK, and efficacy of AT 1501 in patients undergoing kidney transplantation.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Key Eligibility Criteria
Disqualifiers:Previous Transplants, Anticoagulation, Others
Must Not Be Taking:Immunosuppressants, Biologics, Steroids
24 Participants Needed
VST Infusion for Post-Transplant Viral Infections
Cincinnati, Ohio
In this research study, the investigators want to learn more about the use of donor-derived viral specific T-cells (VSTs) to treat viral infections that occur after allogeneic stem cell transplant. A viral specific T cell is a T lymphocyte (a type of white blood cell) that kills cells that are infected (particularly with viruses). Allogeneic means the stem cells come from another person. These VSTs are cells specially designed to fight the virus infections that can happen after a bone marrow transplant.
The investigators are asking people who have undergone or will undergo an allogeneic stem cell transplant to enroll in this research study, because viral infections are a common problem after allogeneic stem cell transplant and can cause significant complications including death.
Stem cell transplant reduces a person's ability to fight infections. There is an increased risk of getting new viral infections or reactivation of viral infections that the patient has had in the past, such as cytomegalovirus (CMV), Epstein-Barr virus (EBV), adenovirus (ADV), BK virus (BKV), and JC virus. There are anti-viral medicines available to treat these infections, though not all patients will respond to the standard treatments. Moreover, treatment of viral infections is expensive and time consuming, with families often administering prolonged treatments with intravenous anti-viral medications, or patients requiring prolonged admissions to the hospital. The medicines can also have side effects like damage to the kidneys or reduction in the blood counts, so in this study the investigators are trying to find an easier way to treat these infections.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1, 2
Age:4+
Key Eligibility Criteria
Disqualifiers:Acute GVHD, Uncontrolled Infection, Others
Must Not Be Taking:ATG, Alemtuzumab
750 Participants Needed
Chemotherapy + Stem Cell Transplant for Fanconi Anemia
Cincinnati, Ohio
The purpose of this study is to determine whether the use of lower doses of busulfan and the elimination of cyclosporine will further reduce transplant-related side effects for patients with Fanconi Anemia (FA). Patients will undergo a transplant utilizing mis-matched related or matched unrelated donors following a preparative regimen of busulfan, fludarabine, anti-thymocyte globulin and cyclophosphamide.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:3+
Key Eligibility Criteria
Disqualifiers:Active CNS Leukemia, HIV, Others
70 Participants Needed
Ambulation for Frailty in Lung Transplant Patients
Cleveland, Ohio
The objective of this study is to assess the feasibility and effectiveness of dedicated ambulator-assisted physical activity in lung transplant inpatients. The primary hypothesis is that an ambulator-assisted intervention for lung transplant patients will prove feasible and may result in improved frailty, hospital outcomes, including less need for inpatient rehabilitation and shorter length of stay in the hospital.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Key Eligibility Criteria
Disqualifiers:Not Listed
200 Participants Needed
Continued Itacitinib Treatment for Myelofibrosis
Cleveland, Ohio
This trial provides the medication itacitinib to participants from previous studies who may benefit from continued treatment. Itacitinib helps reduce inflammation by blocking specific proteins that cause it.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Uncontrolled Illness, Pregnant, Others
Must Be Taking:Itacitinib
18 Participants Needed
Prospera Test for Heart Transplant Rejection
Ann Arbor, Michigan
This is an open label Comparative Effectiveness Research (CER) study in which patients will be randomized at the site level to Prospera surveillance or EMB surveillance in a 2:1 ratio (Prospera to EMB) at each site.
Subjects will be enrolled into the study while under evaluation for heart transplantation or on the transplant waiting list prior to heart transplantation. All subjects will follow the center's standard of care surveillance schedule from transplant through 4 weeks post-transplantation. EMB during this phase is expected to occur roughly weekly or bi-weekly.
Study group assignment will take place at randomization. Subjects will be randomized 30 days (± 10 days) post-transplant to Prospera surveillance versus EMB surveillance in a 2:1 ratio. Rejection surveillance (Prospera Group and EMB Group) will be performed at times corresponding to the institutional standard of care schedule for rejection surveillance.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Unphased
Key Eligibility Criteria
Disqualifiers:Multiple Transplants, Prior Transplants, Pregnant, Others
250 Participants Needed
Cannabidiol + Tacrolimus for Transplant Rejection
Indianapolis, Indiana
This trial aims to understand how CBD, a cannabis compound, interacts with tacrolimus, a drug used by organ transplant patients to prevent rejection. Researchers will study these interactions to see if CBD affects the safety and effectiveness of tacrolimus. Tacrolimus is a strong medication used to prevent organ rejection in transplant patients, with precise dosing requirements. The goal is to help doctors adjust doses of both substances to improve patient health and long-term treatment success.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 1
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Pregnancy, Seizure Disorder, Liver Dysfunction, Others
Must Not Be Taking:Sedatives, Immunosuppressants, CYP3A4/5 Inhibitors
72 Participants Needed
Why Other Patients Applied
"My orthopedist recommended a half replacement of my right knee. I have had both hips replaced. Currently have arthritis in knee, shoulder, and thumb. I want to avoid surgery, and I'm open-minded about trying a trial before using surgery as a last resort."
HZ
Arthritis PatientAge: 78
"As a healthy volunteer, I like to participate in as many trials as I'm able to. It's a good way to help research and earn money."
IZ
Healthy Volunteer PatientAge: 38
"I've been struggling with ADHD and anxiety since I was 9 years old. I'm currently 30. I really don't like how numb the medications make me feel. And especially now, that I've lost my grandma and my aunt 8 days apart, my anxiety has been even worse. So I'm trying to find something new."
FF
ADHD PatientAge: 31
"I've tried several different SSRIs over the past 23 years with no luck. Some of these new treatments seem interesting... haven't tried anything like them before. I really hope that one could work."
ZS
Depression PatientAge: 51
"I changed my diet in 2020 and I’ve lost 95 pounds from my highest weight (283). I am 5’3”, female, and now 188. I still have a 33 BMI. I've been doing research on alternative approaches to continue my progress, which brought me here to consider clinical trials."
WR
Obesity PatientAge: 58
Empagliflozin for Kidney Transplant Recipients
Pittsburgh, Pennsylvania
Kidney transplantation improves the health and quality of life for those Veterans with end stage kidney disease (ESKD). While early patient and graft survival are excellent, long-term outcomes continue to be challenging. Patient death with existing kidney graft function occurs in about half of all recipients over time. This is primarily due to the development of cardiovascular disease in a patient population with multiple preexisting cardiac disease risk factors. There has been little progress in improving outcomes in this area for over two decades. Recent studies in chronic kidney disease (CKD) patients using SGLT2 inhibitors (SGLT2i), regardless of the presence of type 2 diabetes mellitus (T2DM), results in both kidney protective and cardiac protective impacts and improved patient outcomes. However, kidney transplant recipients (KTRs) were excluded from these clinical trials due to concerns that these agents promote infection, diminish graft function, and may alter immunosuppressive drug levels that are the mainstay of patient's transplant therapy. There are limited published data of SGLT2i treatment of selected KTRs.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 4
Age:19+
Key Eligibility Criteria
Disqualifiers:Type 1 Diabetes, HIV, Hepatitis B, Others
Must Not Be Taking:SGLT2 Inhibitors
264 Participants Needed
BIVV020 for Transplant Rejection
London, Ontario
This trial is testing BIVV020, a new drug, to see if it can help prevent or treat a problem called AMR in kidney transplant patients. The drug works by calming the immune system to protect the new kidney.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:ABO Incompatibility, HIV, HBV, HCV, Others
Must Not Be Taking:Complement Inhibitors
48 Participants Needed
Steroids for Kidney Transplant Rejection
London, Ontario
After a kidney or a simultaneous kidney-pancreas transplant, some patients may face problems with their new organs. This happens because the body sometimes makes a mistake and tries to get rid of the organ. This problem is called rejection. One type of rejection is known as Acute T cell mediated rejection (TCMR). This can lead to many problems or even stop the transplant from working.
Doctors give strong steroids to treat this problem, but there are no rules for how much steroid to give. Too much steroids can cause problems like heart and bone problems, bad infections, and weight gain. That is why we need to find the right dose of steroids for each person to treat this.
TACKLE-IT is a study that will try to find the right steroid dose for treating rejection.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Phase 3
Age:2+
Key Eligibility Criteria
Disqualifiers:Mixed Rejection, Active ABMR, Others
Must Not Be Taking:Immunomodulatory Agents
540 Participants Needed
Tacrolimus for Delayed Graft Function
London, Ontario
The investigators hypothesize that preconditioning neurologically deceased organ donors with the calcineurin inhibitor tacrolimus will improve short and long-term transplant survival without causing harm. Organ donors will be randomized to receive either 0.02 mg/kg ideal body weight (IBW) of tacrolimus single infusion or placebo before organ recovery. All corresponding recipients are enrolled and data is collected up to 7 days post-transplant to determine graft function and at 1 year to collect outcomes of vital status, re-transplantation and dialysis. The CINERGY Pilot Trial assesses feasibility for the main trial.
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Hypersensitivity To Tacrolimus, Others
414 Participants Needed
Regulatory T Cell Therapy for Kidney Transplants
Chicago, Illinois
The goal of this multi-national, multi-center, open-label, randomized Phase 2 trial is to determine the safety and efficacy of administering expanded regulatory T cells (TRK-001) to prevent allograft rejection in living donor renal transplant recipients.
Enrolled subjects will be randomized to one of 2 study arms:
Arm 1 subjects will receive standard of care immunosuppression
Arm 2 subjects will receive initial standard of care (SOC) immunosuppression and a single infusion of TRK-001. Three months after the transplant, Arm 2 subjects may be able to begin reducing their immunosuppression medication to a 1-drug regimen.
The primary outcome measures of trial are to evaluate several components indicating immunologic problems with the transplanted organ at 1-year post-transplant and to evaluate the ability for the study subjects given TRK-001 to wean to a 1-drug immunosuppression regimen.
All enrolled subjects will be followed for 5 years post-transplant.
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Age:18 - 65
Key Eligibility Criteria
Disqualifiers:Active Infection, Cardiovascular Disease, Malignancy, Others
Must Be Taking:Immunosuppressants
34 Participants Needed
Immunoclinical Phenotyping for Lung Transplant Rejection
Charlottesville, Virginia
Chronic allograft rejection of the transplanted lung (CLAD) is a major health issue in patients after lung transplant. This study is a registry-forming study with concurrent tissue banking from surveillance bronchoscopy in addition to extra tissue sampling of blood and urine. Patients will be characterized by usual clinical phenotyping and the latest imaging methods so that diseased condition underlying CLAD can be better understood.
No Placebo Group
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Continuous Oxygen Use, Pregnancy, Claustrophobia, Others
1200 Participants Needed
HP 129Xe MRI for Lung Transplant Rejection
Toronto, Ontario
To evaluate the feasibility of hyperpolarized 129Xe MRI in lung transplant recipients and assess structural and functional pulmonary changes using hyperpolarized 129Xe MRI
No Placebo Group
Trial Details
Trial Status:Recruiting
Trial Phase:Phase 2
Key Eligibility Criteria
Disqualifiers:Pregnancy, Psychiatric Disorders, Claustrophobia, Others
15 Participants Needed
Prograf vs Envarsus for Liver Transplant Patients
Toronto, Ontario
Prograf and Envarsus are two different formulations of Tacrolimus which is used as an immunosuppressant in liver transplant (LT) patients. Prograf is currently used as part of the standard immunosuppression regimen for LT recipients at UHN. This study will compare the use of Prograf and Envarsus and their effects on liver and renal function, trough tacrolimus levels, drug-related adverse effects, and patient adherence. Trial design is a pilot randomized trial. The study aims to recruit 40 patients from UHN's LT program and they will be randomized 1:1 to either stay on their current dose of Prograf or be converted to a once-daily equivalent dose of Envarsus. Both groups of patients will be followed for 48 weeks. This study will compare the change from baseline to week 48 in liver and renal function, tacrolimus-related side effects and patient reported outcomes between the two study groups.
No Placebo Group
Trial Details
Trial Status:Enrolling By Invitation
Trial Phase:Phase 4
Key Eligibility Criteria
Disqualifiers:Multiorgan Transplant, Severe Illness, Others
Must Be Taking:Prograf
40 Participants Needed
EASE for Organ Transplant Recipients
Toronto, Ontario
Many transplant recipients may experience physical and emotional symptoms, such as anxiety, fatigue, sleep problems, pain, etc. Often, these symptoms are not reported or managed well, and can affect a patient's quality-of-life. Transplant recipients are grateful for the "gift of life" but physical and emotional symptoms reduce their quality-of-life. Transplant recipients and caregivers have felt unprepared for the ongoing symptoms and reduced quality-of-life post-transplant.
One way of monitoring and managing these symptoms is using the Emotion And Symptom-focused Engagement (EASE) intervention. EASE was originally developed for patients with acute leukemia and has begun to be adapted to help monitor and manage physical and emotional symptoms for organ transplant recipients.
EASE is comprised of two components:
1. Psychological - 8 supportive counselling sessions delivered by mental health clinicians to address concerns about mental health, losses from organ failure, coping with a transplant, experiences with living on the brink of death for a prolonged period of time, etc.
2. Physical - Regular assessments of physical symptoms using questionnaires and referral to healthcare professionals for symptom management as necessary.
EASE uses questionnaires, also called patient reported outcome measures (PROMs), for symptom assessment and monitoring. PROMs measure symptom severity, similarly to how bloodwork measures organ functioning. PROMs, as part of EASE, will ask recipients questions and help identify relevant physical, emotional, and social symptoms to enhance their care.
With the help of specialists, patients, and support from the Kidney Foundation of Canada, our team has begun to adapt the EASE intervention for transplant recipients. In order to finalize the adaptation of the EASE intervention for use in a routine transplant clinic, we are launching a pre-pilot study to gain real-life experience from managing symptoms of SOT recipients with the use of EASE-SOT.
No Placebo Group
Trial Details
Trial Status:Not Yet Recruiting
Trial Phase:Unphased
Age:19+
Key Eligibility Criteria
Disqualifiers:ICU, Clinically Unstable, Delirium, Others
120 Participants Needed
Urine CXCL10 Monitoring for Kidney Transplant Rejection
Toronto, Ontario
This is a Phase II-III multi-center prospective randomized controlled clinical trial of incident adult renal transplant patients.
The primary objective of this study is to determine if the early treatment of rejection, as detected by urinary CXCL10, will improve renal allograft outcomes.
No Placebo Group
Pivotal Trial (Near Approval)
Trial Details
Trial Status:Active Not Recruiting
Trial Phase:Phase 2, 3
Key Eligibility Criteria
Disqualifiers:Blood Group Incompatible, DSA Positive, Others
Must Be Taking:Calcineurin Inhibitors
420 Participants Needed
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Frequently Asked Questions
How much do Transplant Reaction clinical trials pay?
Each trial will compensate patients a different amount, but $50-100 for each visit is a fairly common range for Phase 2–4 trials (Phase 1 trials often pay substantially more). Further, most trials will cover the costs of a travel to-and-from the clinic.
How do Transplant Reaction clinical trials work?
After a researcher reviews your profile, they may choose to invite you in to a screening appointment, where they'll determine if you meet 100% of the eligibility requirements. If you do, you'll be sorted into one of the treatment groups, and receive your study drug. For some trials, there is a chance you'll receive a placebo. Across Transplant Reaction trials 30% of clinical trials have a placebo. Typically, you'll be required to check-in with the clinic every month or so. The average trial length for Transplant Reaction is 12 months.
How do I participate in a study as a "healthy volunteer"?
Not all studies recruit healthy volunteers: usually, Phase 1 studies do. Participating as a healthy volunteer means you will go to a research facility several times over a few days or weeks to receive a dose of either the test treatment or a "placebo," which is a harmless substance that helps researchers compare results. You will have routine tests during these visits, and you'll be compensated for your time and travel, with the number of appointments and details varying by study.
What does the "phase" of a clinical trial mean?
The phase of a trial reveals what stage the drug is in to get approval for a specific condition. Phase 1 trials are the trials to collect safety data in humans. Phase 2 trials are those where the drug has some data showing safety in humans, but where further human data is needed on drug effectiveness. Phase 3 trials are in the final step before approval. The drug already has data showing both safety and effectiveness. As a general rule, Phase 3 trials are more promising than Phase 2, and Phase 2 trials are more promising than phase 1.
Do I need to be insured to participate in a Transplant Reaction medical study?
Clinical trials are almost always free to participants, and so do not require insurance. The only exception here are trials focused on cancer, because only a small part of the typical treatment plan is actually experimental. For these cancer trials, participants typically need insurance to cover all the non-experimental components.
What are the newest Transplant Reaction clinical trials?
Most recently, we added Siltuximab for Rejection, Carfilzomib + Belatacept for Kidney Transplant Rejection and Fostamatinib for Lung Transplant Rejection to the Power online platform.
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