Long-term Outcomes After Conversion to Belatacept

Immunosuppression Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT04733131
• Other study ID #: switch_bela2021
• Status: Active, not recruiting
• Start date: January 1, 2004
• Est. completion date: December 2021

Study information

• Verified date: January 2021
• Source: Paris Translational Research Center for Organ Transplantation
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 324
• Est. completion date: December 2021
• Est. primary completion date: June 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

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

Intervention

Drug:
• Conversion to a belatacept regimen
belatacept intravenous on Days 1, 15, 29, 43, 57 then every 28 days.

Locations

Country	Name	City	State
n/a

Sponsors (1)

Lead Sponsor	Collaborator
Paris Translational Research Center for Organ Transplantation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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
Primary	Patient survival after conversion to belatacept	Patient survival after conversion to a belatacept regimen	5 years