Long-term Outcomes After Conversion to Belatacept

NCT04733131 | Unknown

• 1 other identifier: switch_bela2021
• Study Type: observational
• Target: 324
• Locations: 0 countries
• Sites: N/A

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.

Conditions

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

Keywords

belatacept; multicenter study; Long term outcomes

Outcome Measures

Primary Outcomes (2)

• 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

Study Arms (1)

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

Interventions

Conversion to a belatacept regimen DRUG

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

Also known as: Nulojix

converted to a belatacept based immunosuppression

Eligibility Criteria

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

Study Population

Patients converted to a belatacept regimen after kidney transplant

You may qualify if:

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

You may not qualify if:

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

Sponsors & Collaborators

• Paris Translational Research Center for Organ Transplantation: lead

Related Publications (1)

• 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.

  PMID: 38265815 DERIVED

MeSH Terms

Conditions

Rejection, Psychology

Interventions

Abatacept

Condition Hierarchy (Ancestors)

Social Behavior; Behavior

Intervention Hierarchy (Ancestors)

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

Study Officials

• Alexandre Loupy, MD, PhD

  Paris Translational Research Center for Organ Transplantation

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: OTHER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 26, 2021
• First Posted: February 1, 2021
• Study Start: January 1, 2004
• Primary Completion: June 1, 2021
• Study Completion: December 1, 2021
• Last Updated: February 1, 2021

Record last verified: 2021-01

Data Sharing

• IPD Sharing: Will not share