100 Participants Needed

Carfilzomib + Belatacept for Kidney Transplant Rejection

(CarBel Trial)

Recruiting at 7 trial locations
YM
Overseen ByYvonne Morrison, MS
Age: 18+
Sex: Any
Trial Phase: Phase 2
Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)
Must be taking: Steroids, Immunosuppressants
No Placebo GroupAll trial participants will receive the active study treatment (no placebo)
Prior Safety DataThis treatment has passed at least one previous human trial

Trial Summary

Do I need to stop my current medications for this trial?

The trial does not specify if you need to stop your current medications. However, it mentions that the study drugs are added to the usual immunosuppression treatment, suggesting you may continue your current medications.

What data supports the effectiveness of the drug Belatacept for kidney transplant rejection?

Belatacept is shown to be an effective alternative for preventing organ rejection in kidney transplant patients, offering better long-term kidney function and favorable outcomes compared to traditional treatments.12345

Is the combination of Carfilzomib and Belatacept safe for kidney transplant patients?

Belatacept is generally considered safe for kidney transplant patients, with some experiencing side effects like anemia, fever, and infections. It has a better cardiovascular and metabolic profile compared to other drugs, but there is a higher risk of certain diseases in patients without prior exposure to the Epstein-Barr virus.13567

How is the drug combination of Carfilzomib and Belatacept unique for treating kidney transplant rejection?

The combination of Carfilzomib and Belatacept is unique because Belatacept is a novel immunosuppressive drug that helps prevent organ rejection by blocking specific immune signals, potentially reducing the need for traditional drugs that can cause kidney damage. This approach aims to improve kidney function and reduce side effects compared to standard treatments.148910

What is the purpose of this trial?

The purpose of this study is to see:1. If using these two drugs (carfilzomib and belatacept) together is safe2. 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 kidney3. 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 injury4. If using new computer techniques can help describe important changes seen on biopsy in your donated kidneysThe 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)

Research Team

SJ

Stuart J Knechtle, M.D.

Principal Investigator

Duke University Medical Center: Transplantation

SS

Scott Sanoff, MD, Ph.D.

Principal Investigator

Duke University Medical Center: Transplantation

Eligibility Criteria

This trial is for kidney transplant patients experiencing rejection more than 6 months post-transplant or persistent ABMR less than 6 months after. Participants must be on standard immunosuppression and steroids but still have active chronic ABMR.

Inclusion Criteria

I have a specific type of kidney transplant rejection.
I understand the study and agree to participate.
I recovered from COVID-19 more than 21 days ago.
See 9 more

Exclusion Criteria

Serious medical or mental health issues that could interfere with the study
I was diagnosed or treated for cancer, excluding certain skin cancers, in the last 2 years.
Very low blood counts (hemoglobin, neutrophils, or platelets)
See 25 more

Timeline

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive carfilzomib and belatacept therapy along with steroids and maintenance immunosuppression

3 months
Monthly visits (in-person)

Extended Treatment

Participants continue receiving belatacept, mycophenolate, prednisone, and tacrolimus

3 months
Monthly visits (in-person)

Follow-up

Participants are monitored for safety and effectiveness after treatment

6 months

Treatment Details

Interventions

  • Belatacept
  • Carfilzomib
Trial Overview The study tests the safety and effectiveness of combining Carfilzomib with Belatacept, alongside usual immunosuppressants, to improve kidney function by reducing antibodies against the transplanted organ and affecting immune response.
Participant Groups
2Treatment groups
Experimental Treatment
Group I: Investigational Treatment ArmExperimental Treatment2 Interventions
Study Entry to Month-3 participants will receive: * Steroid pulse/taper * Kyprolis® (Carfilzomib) * Nulojix® (Belatacept) * Tacrolimus * Mycophenolate * Prednisone After 3 months participants will receive: * Belatacept + * Mycophenolate * Prednisone * Tacrolimus
Group II: Conventional Treatment ArmExperimental Treatment2 Interventions
Study Entry to Month-3 participants will receive: * Steroid pulse/taper * Intravenous Immunoglobulin (IVIG) * Tacrolimus OR Belatacept + * Mycophenolate * Prednisone After 3 months participants will receive: * Kyprolis® (Carfilzomib) * Nulojix ® (Belatacept) * Tacrolimus * Mycophenolate * Prednisone After an additional 3 months (6 months from study entry) participants will receive: * Belatacept + * Mycophenolate * Prednisone * Tacrolimus

Find a Clinic Near You

Who Is Running the Clinical Trial?

National Institute of Allergy and Infectious Diseases (NIAID)

Lead Sponsor

Trials
3,361
Recruited
5,516,000+

Findings from Research

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.
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]
Belatacept, a CNI-free immunosuppressive option for kidney transplant patients, has shown improvements in renal function and a lower incidence of chronic allograft nephropathy compared to traditional treatments like cyclosporine.
Patients treated with belatacept also exhibited a more favorable metabolic profile and reduced formation of donor-specific antibodies, suggesting potential long-term benefits for kidney transplant outcomes, although further studies are needed to confirm these effects over time.
A safety evaluation of belatacept for the treatment of kidney transplant.Garcia, VD., Meinerz, G., Keitel, E.[2017]
A 61-year-old woman experienced acute vascular rejection of her kidney transplant 56 days after receiving belatacept, highlighting a potential risk associated with this immunosuppressive therapy.
The rejection was characterized by a predominance of cytotoxic memory T cells, suggesting that these cells may be resistant to the effects of belatacept, indicating a need for further investigation into the mechanisms of rejection in patients treated with this drug.
An Acute Cellular Rejection With Detrimental Outcome Occurring Under Belatacept-Based Immunosuppressive Therapy: An Immunological Analysis.de Graav, GN., Hesselink, DA., Dieterich, M., et al.[2022]

References

Belatacept for the prophylaxis of organ rejection in kidney transplant patients: an evidence-based review of its place in therapy. [2020]
A safety evaluation of belatacept for the treatment of kidney transplant. [2017]
An Acute Cellular Rejection With Detrimental Outcome Occurring Under Belatacept-Based Immunosuppressive Therapy: An Immunological Analysis. [2022]
Early conversion to belatacept-based immunosuppression regimen promotes improved long-term renal graft function in kidney transplant recipients. [2023]
Use of belatacept in kidney transplantation: what's new? [2023]
Introduction to the use of belatacept: a fusion protein for the prevention of posttransplant kidney rejection. [2023]
Advances in immunosuppression for kidney transplantation: new strategies for preserving kidney function and reducing cardiovascular risk. [2015]
Belatacept: in adult kidney transplant recipients. [2016]
Does belatacept improve outcomes for kidney transplant recipients? A systematic review. [2018]
Pharmacokinetics, pharmacodynamics, and immunogenicity of belatacept in adult kidney transplant recipients. [2021]
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