Belatacept for Immunosuppression in Kidney Transplant Recipients

Overseen By David Wojciechowski, DO

Age: 18+

Sex: Any

Trial Phase: Phase 4

Sponsor: University of Texas Southwestern Medical Center

Must be taking: Belatacept

Must not be taking: Investigational drugs

Disqualifiers: Non-kidney transplants, BK nephropathy, others

No Placebo Group All trial participants will receive the active study treatment (no placebo)

Prior Safety Data This treatment has passed at least one previous human trial

Approved in 2 Jurisdictions This treatment is already approved in other countries

Compensation: Varies

Number of Visits: Unknown

25 Participants Needed

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial explores whether kidney transplant patients can safely switch from multiple drugs to just Belatacept, a medication that prevents the body from rejecting the new kidney. Researchers use special blood tests to determine if patients' immune systems are calm enough for this change. Ideal candidates for the trial have had a kidney transplant at least nine months ago, have stable kidney function, and are currently using Belatacept. As a Phase 4 trial, this study involves an FDA-approved treatment and aims to understand how it can benefit more patients.

Will I have to stop taking my current medications?

The trial aims to transition participants from multiple immunosuppressive drugs to Belatacept alone. This suggests you may need to stop some of your current medications, but the protocol does not specify exactly which ones or if there is a specific period to stop them.

What is the safety track record for Belatacept?

Research has shown that Belatacept has been thoroughly studied for safety in kidney transplant patients. In one study, 76% of patients using Belatacept remained in the study for five years post-transplant, indicating it is generally well-tolerated over time. However, some risks exist. Specifically, one study found that 24% of patients experienced kidney rejection, mostly around ten months after switching to Belatacept. While Belatacept can be safe for many, regular check-ups with a doctor are important. Always weigh both the benefits and potential risks when considering joining a trial. ^{1 2 3 4 5}

Why are researchers enthusiastic about this study treatment?

Unlike traditional immunosuppressive therapies for kidney transplant recipients, which typically involve a combination of drugs like tacrolimus, cyclosporine, or corticosteroids, Belatacept offers a different approach by targeting a pathway essential for T-cell activation. This unique mechanism potentially reduces the need for multiple drugs and their associated side effects. Researchers are excited about Belatacept because it may allow patients to maintain stable kidney function with fewer medications, which could lead to a better quality of life and fewer long-term complications from immunosuppression.

What is the effectiveness track record for Belatacept in kidney transplant recipients?

Research has shown that Belatacept is effective for kidney transplant recipients. In this trial, participants will transition to an immunosuppression regimen using only Belatacept. Studies indicate that Belatacept results in fewer cases of kidney rejection compared to other treatments, with rejection occurring in about 8%–12% of patients within the first year. It also improves kidney function over time, with patients showing better kidney performance one year after switching to Belatacept. Additionally, Belatacept use can lower the risk of death, reducing the risk by 38% over seven years for those on a more intensive treatment plan. These findings suggest that Belatacept is a strong option for managing kidney transplants. ^{2 3 5 6 7}

Who Is on the Research Team?

David Wojciechowski, DO

Principal Investigator

UT Southwestern Medical Center

Cyrus Feizpour, MD

Principal Investigator

UT Southwestern Medical Center

Are You a Good Fit for This Trial?

This trial is for adult kidney transplant recipients who have had their new organ for at least 9 months, are on Belatacept or can switch to it, and have stable kidney function. It's not for those with severe liver issues, recent acute rejection episodes, multiple transplants, pregnancy plans during the trial, or current participation in other drug trials.

Inclusion Criteria

I've been on Belatacept for my kidney with stable function for 3 months.

Able to provide informed consent

My organ transplant is from a non-identical donor.

Exclusion Criteria

My current kidney transplant is affected by BK virus.

I am not pregnant, breastfeeding, nor planning to become pregnant during the trial.

I have severe liver problems.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Monitoring

Eligible patients are monitored for immune quiescence over a 3-month period

3 months

Monthly clinic visits

Immunosuppression Taper

Sequential withdrawal of immunosuppression medications over a 12-month period to transition to Belatacept monotherapy

12 months

Monthly clinic visits, blood draws for routine monitoring and genetic testing

Follow-up

Participants are monitored for safety and effectiveness after treatment

12 months

What Are the Treatments Tested in This Trial?

Interventions

• Belatacept

Trial Overview The study tests if DNA markers can help transition patients from multiple immunosuppressant drugs to just Belatacept. Researchers will see if donor-derived cell-free DNA (AlloSure) and gene expression (AlloMap) predict how well a patient's immune system tolerates this change.

How Is the Trial Designed?

Group I: Immunosuppression Taper Experimental Treatment 1 Intervention

Patients included in this arm are kidney transplant recipients with stable kidney function currently on or are converting to a Belatacept based immunosuppression regimen. Eligible patients who are deemed immune quiescent after a 3 month monitoring period will undergo sequential withdrawal of immunosuppression medications over a 12 month period from a three drug regimen to a Belatacept only immunosuppression regimen. During the total 15 month period patients will be monitored with monthly clinic visits, blood draws for routine monitoring as well as donor derived cell free DNA and genetic testing through KidneyCare to monitor immune suppression.

Belatacept is already approved in United States, European Union for the following indications:

Approved in United States as Nulojix for:

• Prophylaxis of organ rejection in adult patients receiving a kidney transplant

Approved in European Union as Nulojix for:

• Prophylaxis of organ rejection in adult patients receiving a kidney transplant

Who Is Running the Clinical Trial?

University of Texas Southwestern Medical Center

Lead Sponsor

Trials

1,102

Recruited

1,077,000+

CareDx

Industry Sponsor

Trials

26

Recruited

15,500+

Published Research Related to This Trial

An accurate and precise assay for measuring belatacept serum concentrations was developed, showing a measurement range of 0.9-30 mg/L and high accuracy (91%-99%).

This assay was applied in a pharmacokinetic study involving 5 renal transplant recipients, allowing for the visualization of belatacept concentrations over time, which is crucial for optimizing immunosuppressive therapy post-transplant.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A Fully Automated Method for the Determination of Serum Belatacept and Its Application in a Pharmacokinetic Investigation in Renal Transplant Recipients. Klaasen, RA., Egeland, EJ., Chan, J., et al.[2019]

Belatacept is as effective as cyclosporine in preventing organ rejection in kidney transplant patients, with similar rates of patient and graft survival and acute rejection, while showing a significant advantage in reducing renal impairment after 12 months.

Patients treated with belatacept experienced fewer serious side effects, including lower rates of new-onset diabetes and better blood pressure and lipid levels compared to those on cyclosporine, indicating a potentially safer profile for long-term use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belatacept: in adult kidney transplant recipients. Garnock-Jones, KP.[2016]

Belatacept is an effective immunosuppressant for kidney transplant recipients, showing noninferior patient and allograft survival compared to cyclosporine in Phase 3 trials, with improved kidney function over three years.

While belatacept may offer benefits like better renal function and cardiometabolic health, it carries a risk of higher early rejection rates and potential increased risk of posttransplant lymphoproliferative disease, particularly in certain patient populations.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belatacept in kidney transplantation. Wojciechowski, D., Vincenti, F.[2018]

Early conversion to belatacept-based immunosuppression after kidney transplantation significantly improved kidney function, as measured by eGFR, from 26.73 to 45.3 ml/min/1.73 m² within one year, while late conversion showed no significant change.

Both early and late conversion groups had a one-year allograft survival rate of 100%, but early conversion was associated with a higher rate of acute T-cell-mediated rejections, suggesting that the choice of immunosuppressants may influence rejection types.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Early conversion to belatacept-based immunosuppression regimen promotes improved long-term renal graft function in kidney transplant recipients. Moein, M., Dvorai, RH., Li, BW., et al.[2023]

Belatacept, a new immunosuppressive drug for kidney transplantation, shows better cardiovascular and metabolic profiles compared to cyclosporin A, including lower blood pressure and serum lipids, and a reduced risk of new onset diabetes after transplantation.

While about 20% of patients on belatacept experienced adverse effects like anemia and infections, it does not appear to increase the risk of infections compared to cyclosporin A, making it a promising option for immunosuppressive therapy.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Introduction to the use of belatacept: a fusion protein for the prevention of posttransplant kidney rejection. Ippoliti, G., D'Armini, AM., Lucioni, M., et al.[2023]

Belatacept, a new immunosuppressant for kidney transplantation, has shown superior graft function and better preservation of renal structure compared to traditional treatments like cyclosporine, based on phase II and III clinical trials.

However, belatacept is associated with a higher risk of cellular rejection and post-transplant lymphoproliferative disorder (PTLD), particularly in patients who are EBV seronegative, indicating the need for careful patient selection.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belatacept: from rational design to clinical application. Wekerle, T., Grinyó, JM.[2017]

Belatacept significantly improves renal function in kidney transplant recipients compared to traditional cyclosporine-based therapy, with a notable increase in estimated glomerular filtration rate (eGFR) of 13-15 mL/min at 1 year and 23-27 mL/min at 7 years, as shown in the BENEFIT study involving standard criteria donors.

In addition to enhancing kidney function, belatacept therapy is associated with lower rates of hypertension, high cholesterol, and new-onset diabetes compared to cyclosporine, although concerns about the risk of posttransplantation lymphoproliferative disorder and the cost of treatment may limit its widespread use.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Belatacept for the prophylaxis of organ rejection in kidney transplant patients: an evidence-based review of its place in therapy. Hardinger, KL., Sunderland, D., Wiederrich, JA.[2020]

Citations

1. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC5724691/

Ten‐year outcomes in a randomized phase II study of kidney ... Cumulative BPAR rates from second randomization to year 10 for belatacept 4‐weekly, belatacept 8‐weekly, and cyclosporine were 11.1%, 21.9%, and 13.9%, ...

2. nejm.org nejm.org/doi/full/10.1056/NEJMoa1506027

Belatacept and Long-Term Outcomes in Kidney ... The reduction in the risk of death at 7 years was 38% with the more-intensive belatacept regimen and 45% with the less-intensive regimen as ...

3. frontierspartnerships.org frontierspartnerships.org/journals/transplant-international/articles/10.3389/ti.2025.14412/full

Belatacept in Kidney Transplantation: Reflecting on the Past ... This regimen has proven to be highly effective, with biopsy-proven acute rejection (BPAR) rates of approximately 8%–12% within the first year ...

4. sciencedirect.com sciencedirect.com/science/article/pii/S2468024925001597

One-Year Outcomes After Belatacept Conversion in ... When looking at the eGFR evolution rate at the individual level, stable patients on belatacept showed significant improvement in graft function at 1 year and a ...

5. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11108246/

Long-Term Outcomes after Conversion to a Belatacept ... After a mean follow-up time of 5.6 (2.6) years after conversion, 67 patients (28%) died in the belatacept group while 87 patients (36%) died in the CNI control ...

6. nulojixhcp.bmscustomerconnect.com nulojixhcp.bmscustomerconnect.com/pooled-safety.html

Selected Pooled Safety Data Polyoma virus-associated nephropathy can lead to deteriorating renal function and graft loss; consider reduction in immunosuppression, weighing risk to the ...

7. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC3013525/

Five-Year Safety and Efficacy of Belatacept in Renal ... At the time of data cutoff, 76% of LTE belatacept and 62% of LTE CsA recipients remained in the study; all were ≥5 years after transplantation.