Long-term Outcomes After Conversion to Belatacept

Long-term Outcomes After Conversion to a Belatacept-based Immunosuppression in Kidney Transplant

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.

Study Overview

• Status: Unknown
• Conditions: Immunosuppression; Kidney Transplant Failure and Rejection; Drug Effect Prolonged; Graft Loss
• Intervention / Treatment: Drug: Conversion to a belatacept regimen

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.

• Study Type: Observational
• Enrollment (Actual): 324

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

• Sampling Method: Non-Probability Sample

Study Population

Patients converted to a belatacept regimen after kidney transplant

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
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.	Drug: Conversion to a belatacept regimen; belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.; Other Names: Nulojix

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Allograft survival after conversion to belatacept	Graft loss is defined as either functional loss or physical loss (nephrectomy). Functional loss is defined as an eGFR< 15 ml/min/1.73m2 or consecutive days of dialysis. For patients who died with a functioning graft, graft survival will be censored at the time of death as a survived or functional graft.	5 years
Patient survival after conversion to belatacept	Patient survival after conversion to a belatacept regimen	5 years

Collaborators and Investigators

• Sponsor: Paris Translational Research Center for Organ Transplantation
• Investigators: Principal Investigator: Alexandre Loupy, MD, PhD, Paris Translational Research Center for Organ Transplantation

Study record dates

Study Major Dates

• Study Start (Actual): January 1, 2004
• Primary Completion (Anticipated): June 1, 2021
• Study Completion (Anticipated): December 1, 2021

Study Registration Dates

• First Submitted: January 26, 2021
• First Submitted That Met QC Criteria: January 29, 2021
• First Posted (Actual): February 1, 2021

Study Record Updates

• Last Update Posted (Actual): February 1, 2021
• Last Update Submitted That Met QC Criteria: January 29, 2021
• Last Verified: January 1, 2021

More Information

Terms related to this study

• Keywords: multicenter study; belatacept; Long term outcomes
• Additional Relevant MeSH Terms: Physiological Effects of Drugs; Molecular Mechanisms of Pharmacological Action; Antirheumatic Agents; Antineoplastic Agents; Immunosuppressive Agents; Immunologic Factors; Immune Checkpoint Inhibitors; Abatacept
• Other Study ID Numbers: switch_bela2021

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No