Abatacept Conversion in Kidney Transplantation

NCT04955366 | Active Not Recruiting Phase 2 DMC FDA Drug

• 1 other identifier: STUDY00001855
• Study Type: interventional
• Target: 87
• Locations: 1 country
• Sites: 1

Brief 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

Keywords

Renal transplant

Outcome Measures

Primary Outcomes (1)

• Change in mean estimated GFR (eGFR) between randomization and 12 months post baseline

  Difference in estimated GFR (eGFR) for abatacept and belatacept groups using a monthly repeated measures model between randomization and 12 months.

  Baseline, 12 months post baseline

Secondary Outcomes (16)

• Change in eGFR between abatacept and belatacept groups at 24 months

  Monthly until 24 months post baseline

• Number of subjects with biopsy proven acute rejection: Acute Cellular Rejection (ACR)

  12 months post baseline, 24 months post baseline

• Number of subjects with biopsy proven acute rejection: Antibody Mediated Rejection (AMR)

  12 months post baseline, 24 months post baseline

• Number of participants with kidney transplant biopsies post baseline

  12 months post baseline, 24 months post baseline

• Proportion of subjects treated for ACR/AMR due to clinical suspicion

  12 months post baseline, 24 months post baseline

Study Arms (2)

Belatacept group (Control Group)

ACTIVE COMPARATOR

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

Drug: Belatacept

Abatacept Group (Conversion Group)

EXPERIMENTAL

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

Drug: Abatacept

Interventions

Belatacept DRUG

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

Also known as: Nulojix

Belatacept group (Control Group)

Abatacept DRUG

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

Also known as: Orencia

Abatacept Group (Conversion Group)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Individuals who meet all of the following criteria are eligible for enrollment as study participants:
• Adult (age ≥18 years currently)
• First-time renal transplant recipients of either living donor or deceased donor
• Treatment with belatacept from the time of transplant
• At least 2 years post-transplant and off CNI therapy for at least 6 months
• Patients at low immunologic risk
• First time transplant
• HLA antibody screen with PRA \< 80% against class I and class II antigens
• Negative crossmatch (actual or virtual)
• No donor specific anti-HLA antibody (DSA)
• No more than one episode of rejection (Banff grade 1A or greater)
• No episodes of rejection (borderline or greater) within the last 6 months prior to study participation
• No rejection of Banff grade IIB or greater
• Immunosuppression consisting of belatacept (5mg/kg q 1M), mycophenolate mofetil (at least 1000 mg daily), or equivalent mycophenolic acid (720 mg daily) or azathioprine (1- 2 mg/kg daily) dose, and prednisone 5 mg daily.
• Confirmed Tb screening at the time of transplantation

You may not qualify if:

• Individuals who meet any of these criteria are not eligible for enrollment as study participants:
• Repeat renal transplant, or multi-organ transplant recipient
• History of more than one episode of biopsy-proven acute rejection (Banff grade 1A or greater), or of any episode of rejection of Banff 97 grade IIB or greater, or any rejection (borderline or greater) within the last 6 months
• Pregnancy (women of childbearing potential must use adequate contraception during study)
• GFR less than 35
• Serum creatinine at enrollment more than 30% higher than at 3 months (±4 weeks) prior to randomization
• Recent history of clinically significant proteinuria (urinary protein/Cr ratio \>1.0)
• Receiving belatacept at a dose other than 5 mg/kg body weight
• Receiving mycophenolate mofetil at a dose of less than 1000 mg po QD (or mycophenolic acid or azathioprine equivalent).
• Receiving prednisone at a dose greater than 5 mg po qd within 3 months of enrollment
• Not currently receiving maintenance immunosuppression with prednisone
• Active infection, or antibiotic or antiviral drug therapy within 1 month of randomization
• Evidence of CMV viremia or clinical CMV infection within the last 3 months prior to randomization.
• BK viremia of greater than 4.3 DNA log copies/mL (greater than 20,000 copies/mL) within 3 months of randomization
• Known hepatitis B surface antigen-positive or PCR-positive for hepatitis B (testing not required)

Sponsors & Collaborators

• Emory University: lead

Study Sites (1)

Emory University Hospital (EUH)

Atlanta, Georgia, 30322, United States

Location

MeSH Terms

Interventions

Abatacept

Intervention Hierarchy (Ancestors)

Immunoconjugates; Antibodies; Immunoglobulins; Serum Globulins; Blood Proteins; Proteins; Amino Acids, Peptides, and Proteins; Globulins

Study Officials

• Idelberto R Badell, MD

  Emory University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Assistant Professor

Model Details: Prospective, randomized controlled non-inferiority trial

Study Record Dates

• First Submitted: June 28, 2021
• First Posted: July 8, 2021
• Study Start: September 22, 2021
• Primary Completion (Estimated): June 1, 2026
• Study Completion (Estimated): June 1, 2026
• Last Updated: October 14, 2025

Record last verified: 2025-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Beginning 9 months and ending 36 months following article publication.
• Access Criteria: Proposals may be submitted up to 36 months following article publication. After 36 months the data will be available in our University\&amp;amp;amp;amp;amp;amp;amp;#39;s data warehouse but without investigator support other than deposited metadata. Individual participant data that underlie the results reported in this article will be shared, after de identification (text, tables, figures, and appendices) to Investigators whose proposed use of the data has been approved by an independent review committee ("learned intermediary") identified for this purpose, for individual participant data meta-analysis.

Locations

US (1)