Your session is about to expire
← Back to Search
Small Molecule
Immunological Tolerance Therapy for Kidney Transplant Rejection
Phase 1
Recruiting
Research Sponsored by University of California, Los Angeles
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 36 months
Awards & highlights
Study Summary
This trial studies if a drug can make kidney-hematopoietic stem cell transplants safer and more successful.
Who is the study for?
Adults over 18 eligible for kidney and stem cell transplants can join this trial if they have a matched living donor, are not pregnant, agree to use contraception, live near UCLA Medical Center, and have good heart, liver, and lung function. Excluded are those with certain infections or diseases requiring immunosuppression, recent drug abuse history, very high BMI or previous organ transplants.Check my eligibility
What is being tested?
The study is testing the safety and effectiveness of belumosudil in improving transplant tolerance when given alongside a combined kidney and hematopoietic stem cell transplant from either a half-matched related donor or an unrelated donor with minimal HLA mismatches.See study design
What are the potential side effects?
Potential side effects of belumosudil may include changes in blood counts leading to increased risk of infection or bleeding. Other risks could involve allergic reactions to the medication as well as possible impacts on liver function.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 36 months
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~36 months
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Determine impact of treatment regimen on patient and kidney allograft survival
Secondary outcome measures
Determine probability of successful withdrawal of immunosuppression
Determine risk of acute and/or chronic graft vs host disease
Determine risk of kidney allograft rejection
Side effects data
From 2014 Phase 2 trial • 8 Patients • NCT0210619525%
Transaminase increased
13%
Nausea
13%
Vomiting
13%
Pyrexia
13%
Fall
13%
Rib Fracture
13%
Tooth ache
13%
Nephrolithiasis
13%
Anastomotic ulder
13%
Somnolence
13%
Hypokalemia
13%
Anastomotic ulcer
100%
80%
60%
40%
20%
0%
Study treatment Arm
Belumosudil 200 mg PO QD
Trial Design
1Treatment groups
Experimental Treatment
Group I: Immune tolerance in mismatched kidney transplant recipientExperimental Treatment1 Intervention
Our goal is to establish this regimen as a novel, safe and effective approach for induction of transplant tolerance in HLA single haplotype-matched related and HLA mismatched unrelated recipients of combined Hematopoietic Stem Cell Transplant(HSCT)/ Kidney Transplant (KT). Patients will undergo conditioning with rATG and TLI, followed by infusion of hematopoeitic stem cells from the same donor, a triple immunosuppressive regimen, and receive belumosudil following the kidney transplant. Immunosuppression taper will be stopped and/or immunosuppression will be resumed for any of the following conditions:
(1) loss of chimerism 2) clinical or pathological evidence of acute rejection and (3) clinical or pathological evidence of graft vs host disease.
Find a Location
Who is running the clinical trial?
University of California, Los AngelesLead Sponsor
1,532 Previous Clinical Trials
10,265,252 Total Patients Enrolled
1 Trials studying Kidney Failure
5 Patients Enrolled for Kidney Failure
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have been treated with rATG or am allergic to rabbit proteins.I have had a transplant involving multiple organs.I agree to use effective birth control methods if I'm of reproductive age.I am getting a kidney and stem cell transplant from a partially matched donor.I have been treated with belumosudil before.I have severe liver scarring.My liver tests are within the required range.My kidney disease is likely to come back.I am not pregnant and agree to use birth control.I have had radiation therapy before.I haven't taken any drugs that weaken my immune system recently.I have a positive HLA antibody test.My liver does not have severe scarring.I have recently used drugs that affect my immune system.I have heart issues like failure, artery disease, or irregular heartbeat.I haven't had any cancer except for certain types in the last 5 years.I have had a solid organ transplant.I agree to join the study and can give my consent.I am 18 years old or older.I have tested negative for COVID-19 and/or am vaccinated.My blood type matches with the donor's.I have not had a multi-organ transplant.I have never been treated with rATG and I am not allergic to rabbit proteins.I have never been treated with belumosudil.I do not have positive HLA antibodies.I do not have an active autoimmune disease outside my kidneys that needs treatment to lower my immune response.I do not have any active infections or known viruses.I do not have end-stage kidney disease due to specific causes.I have never received radiation therapy.I have never smoked 20 or more packs of cigarettes a year.I do not have heart failure, heart disease symptoms, or uncontrolled irregular heartbeat.I do not have kidney disease that is likely to come back.I am taking medication to suppress my immune system due to an autoimmune disease outside of my kidneys.My heart pumps well, with an ejection fraction of 40% or higher.I have end-stage renal disease due to a specific cause.I have not had any cancer except for certain types in the last 5 years.I am mostly able to care for myself.I am eligible for a kidney and stem cell transplant according to my hospital's rules.My lung function tests are at least half of what is expected.I have no known allergies or adverse reactions to rATG or radiation.
Research Study Groups:
This trial has the following groups:- Group 1: Immune tolerance in mismatched kidney transplant recipient
Awards:
This trial has 1 awards, including:- No Placebo-Only Group - All patients enrolled in this study will receive some form of active treatment.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Are individuals able to submit applications for this clinical trial?
"This trial is not presently enrolling, as indicated on clinicaltrials.gov--the original posting was made on May 1st 2023 and the most recent updates were applied on April 6th 2023. Nevertheless, there are currently 622 other trials searching for participants at this time."
Answered by AI
What risks might be associated with immunological acceptance of a donor organ in incompatible kidney transplant patients?
"The safety of Immune tolerance in mismatched kidney transplant recipient was given a score of 1, indicating limited clinical data for both efficacy and security."
Answered by AI
Recent research and studies
Other Trials to Consider
Popular Categories
Share this study with friends
Copy Link
Messenger