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Abatacept Conversion in Kidney Transplantation

NCT04955366 · Status: ACTIVE_NOT_RECRUITING · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 87

Last updated 2025-10-14

No results posted yet for this study

Summary

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.

Conditions

  • Renal Transplant Recipient

Interventions

DRUG

Belatacept

Belatacept is an immunosuppressive medication and will be given as an intravenous infusion at a dose of 5 mg/kg monthly

DRUG

Abatacept

Abatacept is an immunosuppressive medication and will be given SQ at a dose of 125 mg s.c. weekly

Sponsors & Collaborators

  • Emory University

    lead OTHER

Principal Investigators

  • Idelberto R Badell, MD · Emory University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2021-09-22
Primary Completion
2026-06-30
Completion
2026-06-30
FDA Drug
Yes

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT04955366 on ClinicalTrials.gov