Long-term Outcomes After Conversion to Belatacept

NCT ID: NCT04733131

Last Updated: 2021-02-01

Basic Information

• Recruitment Status: UNKNOWN
• Total Enrollment: 324 participants
• Study Classification: OBSERVATIONAL
• Study Start Date: 2004-01-01
• Study Completion Date: 2021-12-31

Brief Summary

belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant have not been yet reported.

Detailed Description

belatacept is a selective T-cell co-stimulation blocker that was approved by Food and Drug Administration (FDA) in 2011 for the prophylaxis of graft rejection in adult kidney transplant recipients. This treatment is indicated as an alternative to Calcineurin Inhibitors (CNIs) for prophylaxis of graft rejection in de novo renal transplant recipients. Major studies evaluating belatacept showed that de novo kidney transplant patients treated with belatacept presented an improved renal function with a higher average estimated glomerular filtration rate (eGFR) compared to ciclosporin (CsA) regimen in patients. Conversion to belatacept after transplant seems to be safe even in highly sensitized patients. However, long term efficacy and safety outcomes of a kidney transplant population converted to a belatacept regimen after transplant and compared to a matched control group under a CNIs regimen have not been yet reported.

A multicenter cohort of kidney transplant patients, will be use to match patients converted to a belatacept immunosuppressive regimen to a control group under CNIs immunosuppressive regimen.

Conditions

Kidney Transplant Failure and Rejection; Immunosuppression; Graft Loss; Drug Effect Prolonged

Study Design

• Observational Model Type: COHORT
• Study Time Perspective: OTHER

Study Groups

converted to a belatacept based immunosuppression

Belatacept: infusion on Days 1, 15, 29, 43, 57 then every 28 days. All patients received a background maintenance immunosuppressive regimen of mycophenolate mofetil or mycophenolic acid, with adjunctive corticosteroids, according to their immunosuppressive regimen at the time of enrollment.

Conversion to a belatacept regimen

Intervention Type: DRUG

belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.

Interventions

Conversion to a belatacept regimen

belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.

Intervention Type: DRUG

Other Intervention Names

Nulojix

Eligibility Criteria

Inclusion Criteria

• Male or Female, over 18 years of age
• Recipient of kidney allograft from a living donor or a deceased donor

Exclusion Criteria

• Graft loss during the first three months post-transplant
• Epstein-Barr virus Seronegative in the belatacept group

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Paris Translational Research Center for Organ Transplantation

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Alexandre Loupy, MD, PhD

Role: PRINCIPAL_INVESTIGATOR

Paris Translational Research Center for Organ Transplantation

References

Divard G, Aubert O, Debiais-Deschamp C, Raynaud M, Goutaudier V, Sablik M, Sayeg C, Legendre C, Obert J, Anglicheau D, Lefaucheur C, Loupy A. Long-Term Outcomes after Conversion to a Belatacept-Based Immunosuppression in Kidney Transplant Recipients. Clin J Am Soc Nephrol. 2024 May 1;19(5):628-637. doi: 10.2215/CJN.0000000000000411. Epub 2024 Feb 22.

Reference Type: DERIVED

PMID: 38265815 (View on PubMed)

Other Identifiers

switch_bela2021

Identifier Type: -

Identifier Source: org_study_id