CI

At a glance

ClinicalIndex Comparison Record
Phase 1Completed· 16 enrolled
Drug / intervention
Abatacept 125Mg/Ml Syringedrug
Likely dose
Abatacept 125Mg/Ml Syringefrom record
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Search/NCT05975450
NCT05975450Phase 1Completed

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

Idelberto Badell·interventional·Posted Aug 3, 2023·Updated Apr 3, 2026

In Brief

A Phase 1 clinical trial evaluating Abatacept 125Mg/Ml Syringe for Kidney Transplant Recipient. Completed, enrolled 16 participants across 2 sites.

Detailed 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?

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited States

Timeline

Phase 1CompletedFinished
202420252026
First PostedAug 3, 2023
Enrollment StartAug 2, 2023
Primary CompletionFeb 14, 2025
TodayJul 2, 2026
Enrollment to primary: 1.5 yearsPosted 2.9 years ago

Interventions

Abatacept 125Mg/Ml Syringedrug

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