CLINICAL TRIAL

belatacept for Renal Transplant Recipient Patients

Recruiting · 18+ · All Sexes · Durham, NC

This study is evaluating whether it is safe to give mesenchymal stromal cells to kidney transplant recipients, and the combination of the immunosuppressive (anti-rejection) study drugs plus the MSCs can allow a kidney transplant recipient to slowly reduce and/or then completely stop

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About the trial for Renal Transplant Recipient Patients

Eligible Conditions
Renal Transplant Recipient Patients · Kidney Transplantation

Treatment Groups

This trial involves 3 different treatments. Belatacept is the primary treatment being studied. Participants will be divided into 3 treatment groups. There is no placebo group. The treatments being tested are in Phase 1 and are in the first stage of evaluation with people.

Experimental Group 1
belatacept
DRUG
+
sirolimus
DRUG
+
prednisone
DRUG
+
Donor-derived Mesenchymal Stromal Cells
BIOLOGICAL
+
alemtuzumab
DRUG
+
mycophenolate mofetil
DRUG
+
mycophenolate acid
DRUG
Experimental Group 2
belatacept
DRUG
+
sirolimus
DRUG
+
prednisone
DRUG
+
Donor-derived Mesenchymal Stromal Cells
BIOLOGICAL
+
alemtuzumab
DRUG
+
mycophenolate mofetil
DRUG
+
mycophenolate acid
DRUG
Experimental Group 3
belatacept
DRUG
+
sirolimus
DRUG
+
prednisone
DRUG
+
Donor-derived Mesenchymal Stromal Cells
BIOLOGICAL
+
alemtuzumab
DRUG
+
mycophenolate mofetil
DRUG
+
mycophenolate acid
DRUG

About The Treatment

Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Belatacept
FDA approved
Sirolimus
FDA approved
Prednisone
FDA approved
Alemtuzumab
FDA approved
Mycophenolate mofetil
FDA approved

Eligibility

This trial is for patients born any sex aged 18 and older. There are 9 eligibility criteria to participate in this trial as listed below.

Inclusion & Exclusion Checklist
Mark “yes” if the following statements are true for you:
Evidence of established immunity to Epstein-Barr Virus (EBV) as demonstrated by serologic testing;
A negative serum or urine pregnancy test with sensitivity of less than 50 mIU/mL within 72 hours of start of study medication;
--Candidates must meet the United Network for Organ Sharing (UNOS) criteria, including laboratory criteria, for transplant listing;
Serological evidence of prior Cytomegalovirus (CMV) infection if donor is CMV positive;
--- According to the FDA Office of Women's Health (http://www.fda.gov/birthcontrol), there are a number of birth control methods that are more than 80% effective
----Female recipients of child-bearing potential must consult with their physician and determine the most suitable method(s) from this list to be used for 18 months after the first dose of study therapy.
(i) FDA 21 CRF 1271.85 requirements for donors of human cells, tissues, and cellular- and tissue-based products (HCT/P);
(ii) standards for living kidney donors testing for infection established by the United Network for Organ Sharing (UNOS).
Ability to understand and provide informed consent for all study procedures including kidney transplant and bone marrow harvest.
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Odds of Eligibility
Unknown<50%
Be sure to apply to 2-3 other trials, as you have a low likelihood of qualifying for this one.Apply To This Trial
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Approximate Timelines

Please note that timelines for treatment and screening will vary by patient
Screening: ~3 weeks
Treatment: varies
Reporting: From kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)
Screening: ~3 weeks
Treatment: Varies
Reporting: From kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years)
This trial has approximate timelines as follows: 3 weeks for initial screening, variable treatment timelines, and reporting: From kidney transplant with alemtuzumab induction to to completion of study (up to approximately 6.5 years).
View detailed reporting requirements
Trial Expert
Connect with the researchersHop on a 15 minute call & ask questions about:
- What options you have available- The pros & cons of this trial
- Whether you're likely to qualify- What the enrollment process looks like

Measurement Requirements

This trial is evaluating whether belatacept will improve 1 primary outcome and 11 secondary outcomes in patients with Renal Transplant Recipient Patients. Measurement will happen over the course of 48 weeks from the time of last sirolimus dose.

Proportion of Participants who Achieve Belatacept Monotherapy
48 WEEKS FROM THE TIME OF LAST SIROLIMUS DOSE
Belatacept monotherapy, defined as remaining on belatacept as the sole maintenance regimen for 48 weeks with: No evidence of biopsy-proven allograft rejection, while on belatacept monotherapy; Acceptable renal function, defined as an estimated GFR > 60 ml/min/1.73m^2 calculated using the CKD-EPI equation or a serum creatinine that has increased no more than 25% above baseline, as assessed at week 48 on belatacept monotherapy; No evidence of sustained transplant renal derived pathologic proteinuria, defined as a persistent protein creatinine ratio of greater than 0.5, while on belatacept monotherapy; and No Donor Specific Antibodies (DSA) at any time while on belatacept monotherapy.
48 WEEKS FROM THE TIME OF LAST SIROLIMUS DOSE
Proportion of Participants who Achieve Operational Tolerance
52 WEEKS AFTER COMPLETION OF IMMUNOSUPPRESSION WITHDRAWAL (ISW)
Operational tolerance (to their kidney transplant) defined by participant remaining off all immunosuppression for 52 weeks after completion of Immunosuppression Withdrawal (ISW) with: No evidence of biopsy-proven allograft rejection after initiation of ISW; Acceptable renal function, defined as an estimated GFR > 60 ml/min/1.73cm^2 calculated using the CKD-EPI equation or a serum creatinine that has increased no more than 25% above baseline, as assessed at the week 52 visit after completion of ISW; No evidence of sustained transplant renal derived pathologic proteinuria, defined as a persistent protein creatinine ratio of greater than 0.5; and No Donor Specific Antibodies (DSA) at any time after completion of ISW.
52 WEEKS AFTER COMPLETION OF IMMUNOSUPPRESSION WITHDRAWAL (ISW)
Incidence of Adverse Events Attributable to Mesenchymal Stromal Cells (MSC) Administration
FROM INITIAL MCS INFUSION (DAY 42 POST KIDNEY TRANSPLANT) TO END OF STUDY PARTICIPATION (UP TO 7 YEARS)
According to medical assessment/outcomes, investigator's brochure for MSCs, literature et al.
FROM INITIAL MCS INFUSION (DAY 42 POST KIDNEY TRANSPLANT) TO END OF STUDY PARTICIPATION (UP TO 7 YEARS)
Proportion of Participants who Remain Off Immunosuppression
FROM ISW COMPLETION TO END OF STUDY PARTICIPATION (UP TO APPROXIMATELY 5 YEARS)
For the duration of their study participation, after completion of immunosuppression withdrawal (ISW).
FROM ISW COMPLETION TO END OF STUDY PARTICIPATION (UP TO APPROXIMATELY 5 YEARS)
Proportion of Participants who Return to Immunosuppression
FROM ISW COMPLETION TO END OF STUDY PARTICIPATION (UP TO APPROXIMATELY 5 YEARS)
Resumption of immunosuppressive therapy post completion of Immunosuppression Withdrawal (ISW), per standard of care.
FROM ISW COMPLETION TO END OF STUDY PARTICIPATION (UP TO APPROXIMATELY 5 YEARS)
Incidence of Post-Transplant Diabetes
FROM POST KIDNEY TRANSPLANTATION TO COMPLETION OF STUDY (UP TO APPROXIMATELY 7 YEARS)
New onset diabetes status post transplant (posttransplantation diabetes mellitus [PTDM])
FROM POST KIDNEY TRANSPLANTATION TO COMPLETION OF STUDY (UP TO APPROXIMATELY 7 YEARS)
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Patient Q & A Section

Please Note: These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

What are common treatments for kidney transplantation?

There is no direct comparison with the best-of-many (BOOM) concept because of the unsuitability and complexity of these studies. The data that have been collected suggests that [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation has fewer problems than anticipated since it is a better way to treat end-stage kidney disease and that it helps prevent complications of chronic kidney failure from progressing to end-stage kidney disease.\n\nIt has been estimated that as many as one in every five people are affected with ADHD during their lifetime. The condition is more common amongst men. The prevalence of ADHD in children ranges from approximately 2% to 12% in the United States.\n\nThere are many treatments for ADHD.

Anonymous Patient Answer

What are the signs of kidney transplantation?

In summary, the main signs of transplantation, such as loss of graft function, occurrence of an acute rejection, a decrease in graft function due to chronic rejection or other immunologic diseases, are frequently seen. However, this is only a very general overview and for each individual the clinician must take into account the peculiar situation of the patient.

Anonymous Patient Answer

Can kidney transplantation be cured?

There is no cure for end-stage organ failure caused by all chronic conditions. However, [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation can be curative as transplanting only dysfunctional organs can extend patient and graft survival. In a recent study, findings of the aforementioned studies indicate that transplanted living kidney tissue is able to heal even after complete organ failure. In addition to kidney transplantation, heart and lung transplantation are curative and can extend life and health with appropriate transplantation protocols. [Organ replacement and transplantation for cure. - End-stage transplantation of organs, organs and life prolonging transplantation. - End-stage organ failure, organ transplantation, transplantation of organs, organ transplants, organ replacement, transplantation, heart_lung.

Anonymous Patient Answer

What is kidney transplantation?

The long-term benefits of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation are not clear. There is concern that it may increase the risk of some diseases, including cancer of the lung, liver, and prostate. There is no conclusive evidence that transplantation carries an increased risk of dying early. There is no evidence that individuals who receive a kidney transplant are at a higher risk of developing end stage renal disease when compared to the general population. For most recipients kidney transplantation is probably the best option when options for treating end stage renal disease are limited.

Anonymous Patient Answer

What causes kidney transplantation?

Transplantation appears to be rare due to a combination of factors - the recipient is a relatively young patient on dialysis or a sibling with a renal disorder.

Anonymous Patient Answer

How many people get kidney transplantation a year in the United States?

5.3 percent of the population will require dialysis in 2050, due to an ageing population, high incidence of [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)-related complications (mainly cardiac graft failure), and a shortage of donor organs. The average life expectancy will be 6.5 years in 2050. Because of medical advances, the average survival time after kidney transplantation will not increase. In 2050, the number of patients on dialysis will be 924,000. The number of patients on the waiting list for a kidney transplant will be 35,000. For the future, the number of transplant centers, especially in-patient units, will be necessary.

Anonymous Patient Answer

Is belatacept typically used in combination with any other treatments?

The majority of subjects treated with belatacept reported some form of treatment with other treatments. The most common combinations included belatacept with: basiliximab (26%), rituximab (20%), tacrolimus (20%), ciclosporin (16%), cyclosporine (10%), and cyclophosphamide (10%). Subjects were generally willing to try these therapies and reported no significant adverse events with these combinations, although only a few were sufficiently long to determine an association with belatacept. Subjects tolerated some combination therapies better than others. For example, subjects taking belatacept and basiliximab had fewer adverse events than subjects taking belatacept and tacrolimus.

Anonymous Patient Answer

How does belatacept work?

Belatacept decreased the number of circulating B cells, as well as the overall B cell subsets in peripheral and lymphoid tissues and improved overall and disease-specific survival in the MERS-CoV mouse model of human coronavirus infection that causes Middle East respiratory syndrome/severe acute respiratory syndrome (MERS/SARS).

Anonymous Patient Answer

What is belatacept?

Belatacept is well tolerated in renal transplant patients treated with MMF/cyclosporine A with or without corticosteroids. An effect on renal function or a clinical benefit has not been demonstrated. A small percentage of patients discontinue belatacept due to adverse events. Data from a recent study are very reassuring. A randomized, controlled, prospective study with a similar design is planned to evaluate efficacy of belatacept in renal transplant patients treated with MMF/cyclosporine A. It will allow determination of the effect of belatacept on renal function over time. A 24-week trial would be sufficient.

Anonymous Patient Answer

What are the latest developments in belatacept for therapeutic use?

In early phase III clinical trials for ESRD, bOS 49-59 is no worse than c-MPR but superior to belatacept. A randomized, controlled phase III trial with a 3-year follow-up may determine whether bOS or c-MPR is the superior option for bOS.

Anonymous Patient Answer

Who should consider clinical trials for kidney transplantation?

Clinicians must determine who can receive [kidney transplant](https://www.withpower.com/clinical-trials/kidney-transplant)ation based on available guidelines and clinical knowledge. Trials designed to identify patient and treatment characteristics that increase transplantation are necessary, but there is no evidence that the clinical characteristics of patients with end stage kidney disease enable them to participate in these trials.

Anonymous Patient Answer

Does belatacept improve quality of life for those with kidney transplantation?

Improvement in QoL was sustained over 2 years. Belatacept treatment was not associated with improved QoL except for one subset of treatment patients who reported increased appetite.

Anonymous Patient Answer
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