NCT05975450

Subcutaneous Abatacept in Renal Transplant Recipients

Early Substitution of Subcutaneous Abatacept for Belatacept as Costimulation Blockade to Minimize Calcineurin Inhibitors (CNI) Exposure After Kidney Transplantation

• Status: Completed
• Phase: Phase 1
• Study type: Interventional
• Enrollment: 16 (actual)
• Sponsor: Idelberto Badell · Academic / Other
• Sex: All
• Age: 18 Years – 70 Years
• Healthy volunteers: Not accepted

Summary

After a kidney transplant, patients take drugs called anti-rejection drugs (immunosuppressives) to prevent their bodies from rejecting the new kidney. At present it is not possible to have a successful transplant without these drugs. These drugs make it possible for a person who receives the transplant to accept the "foreign" kidney. Most patients who get a transplant need to take anti-rejection medications for the rest of their lives, or for as long as the kidney continues to work. Researchers are looking to learn whether abatacept is as good as belatacept in preventing rejection, whether there are other benefits or harms associated with abatacept treatment, and possibly allows greater flexibility on patient's travel and time since abatacept is self-administered at home. This study is being done to answer these questions: Are weekly abatacept injections under the skin a safe and effective substitute for monthly belatacept intravenous (IV) infusions? and How well does the kidney function after switching from belatacept to abatacept?

Detailed description

This is a Phase I, open-label, prospective, single-arm single-center study to evaluate the feasibility, effectiveness, and safety of a regimen substituting subcutaneous abatacept early post-transplant in place of intravenous belatacept as an immunosuppressant in first-time renal transplant recipients. There is a single arm in this study; the Investigational (abatacept) group. Participants will be assigned to a treatment regimen between 2 and 5 months after transplantation. The study drug will be administered until month 12 post-transplant; at that point, all participants will be transitioned to a physician-directed immunosuppressive regimen post-study.

Conditions

• Kidney Transplant Recipient

Interventions

Type	Name	Description
DRUG	Abatacept 125Mg/Ml Syringe	Participants on a qualifying belatacept regimen (with low-dose tacrolimus, mycophenylate mofetil (MMF), and prednisone) will have their maintenance regimen changed from i.v. Belatacept to s.c. abatacept, which will continue through week 52 (month 12) post-transplant: Costimulation blockade: \- Abatacept 125 mg subcutaneous weekly

Timeline

• Start date: 2023-08-02
• Primary completion: 2025-02-14
• Completion: 2025-02-14
• First posted: 2023-08-03
• Last updated: 2026-04-03
• Results posted: 2026-04-03

Locations

2 sites across 1 country: United States

Regulatory

• FDA-regulated drug study