Abatacept Conversion for Kidney Transplant Recipients

Recruiting in Palo Alto (17 mi)

Overseen byIdelberto R Badell, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Emory University

No Placebo Group

Prior Safety Data

Breakthrough Therapy

Trial Summary

What is the purpose of this trial?This is a single center, randomized, controlled phase 2b, conversion trial. This protocol has been developed to answer the question: Can patients be safely converted from monthly belatacept IV infusions to abatacept subcutaneous injections without a decrease in kidney function.The primary objective will be the difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.

Eligibility Criteria

This trial is for adults over 18 who've had their first kidney transplant from a living or deceased donor at least two years ago, are on specific immunosuppressants including belatacept, and have stable kidney function. They shouldn't have severe rejection history, active infections, significant proteinuria, uncontrolled diabetes, or be pregnant.

Inclusion Criteria

No rejection of Banff grade IIB or greater

I haven't had any organ rejection episodes in the last 6 months.

Negative crossmatch (actual or virtual)

+11 more

Exclusion Criteria

Recent history of clinically significant proteinuria (urinary protein/Cr ratio >1.0)

I am taking belatacept, but not at a 5 mg/kg dose.

BK viremia of greater then 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization

+17 more

Participant Groups

The study compares monthly intravenous infusions of belatacept with subcutaneous injections of abatacept in maintaining kidney function post-transplant. It's a phase 2b trial to see if patients can switch between these treatments without harming their new kidney.

2Treatment groups

Experimental Treatment

Active Control

Group I: Abatacept Group (Conversion Group)Experimental Treatment1 Intervention

Participants will receive the following: * Abatacept 125 mg s.c. weekly * Safety labs every 2 weeks (months 0-3) then monthly (months 4-12) * Blood draws forPK atMonth 6, Month 12, and two random time points in between Month 6 and Month 12 for a total of four time points. * Blood draws for PD studies at baseline/Month0 and Month 6 fora total of two timepoints. * HLA labs at 6, 12 and 24 months * Basic chemistry panel (CP Basic) at each study visit per clinical protocol for efficacy analysis * Hemoglobin A1c at Screening visit * Urine pregnancy test via test kit for WOCP at screening * BK and CMV testing at 6, 12, and 24 months

Group II: Belatacept group (Control Group)Active Control1 Intervention

Participants will receive the following: * Belatacept: 5 mg/kg i.v. monthly * Blood draws for PD studies at baseline/Month 0 and Month 6 fora total of two timepoints. * HLA labs at 6, 12 and 24 months * Basic chemistry panel (CP Basic) every 3 months per clinical protocol for efficacy analysis * Hemoglobin A1c at Screening visit * Urine pregnancy test via test kit for WOCP at Screening visit * BK and CMV testing at 6, 12, and 24 months

Abatacept is already approved in European Union, United States, Canada, Japan for the following indications:

🇪🇺 Approved in European Union as Orencia for: