Clinical Trials Logo

Clinical Trial Details — Status: Active, not recruiting

Administrative data

NCT number NCT04733131
Other study ID # switch_bela2021
Secondary ID
Status Active, not recruiting
Phase
First received
Last updated
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
Health authority
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

Study Design


Related Conditions & MeSH terms


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
See also
  Status Clinical Trial Phase
Recruiting NCT05060991 - Impact of Immunosuppression Adjustment on COVID-19 Vaccination Response in Kidney Transplant Recipients Phase 4
Completed NCT02833805 - NMA Haplo or MUD BMT for Newly Diagnosed Severe Aplastic Anemia Phase 2
Completed NCT01252537 - Immunosuppression in HIV-infected Patients With Tuberculosis in Ethiopia N/A
Completed NCT00621699 - Pharmacokinetic Drug Interaction Between Ezetimibe and Tacrolimus After Single Dose Administration in Healthy Subjects Phase 1
Completed NCT01678937 - Immune Tolerance and Alloreactivity in Liver Transplant Recipients on Different Monotherapy Immunosuppressive Agents N/A
Completed NCT00788021 - Protective Immunity Project 01 N/A
Active, not recruiting NCT00166842 - Sirolimus Blood Concentrations on Conversion From Oral Solution to Tablets Phase 4
Recruiting NCT05616130 - Pathological Myeloid Activation After Sepsis and Trauma
Completed NCT03117192 - Zinc Supplementation on Cellular Immunity in Thalassemia Major Phase 4
Recruiting NCT01568697 - Oral Bacteria and Immune System Problems Involved in Gum Disease (Periodontitis)
Not yet recruiting NCT06024226 - Role of MDSCs and Cancer Stem Cells and Their Cross Talks in NSCLC
Not yet recruiting NCT04961229 - Booster Dose of COVID-19 Vaccine for Kidney Transplant Recipients Without Adequate Humoral Response Phase 4
Completed NCT03139565 - High Dose vs. Standard Influenza Vaccine in Adult SOT Phase 3
Completed NCT02547753 - Dental Extractions Among Renal Transplant Recipients
Completed NCT01702207 - Evaluation Of Switching From Twice Daily Tacrolimus To Once Daily Formulation On Cardiovascular Risk Phase 4
Completed NCT00626808 - A Post Marketing Evaluation of the Effectiveness of FluMist Risk Minimization Plan in Children Phase 4
Completed NCT00419575 - Renal Transplantation With Immune Monitoring N/A
Completed NCT00783380 - Influenza Vaccination in Immunocompromized Patients Phase 4
Completed NCT04835948 - Efficacy of Single Dose Anti-thymocyte Globulin in the Modulation of T Lymphocytes in Kidney Transplantation
Recruiting NCT05043870 - Combined Immunosuppression for Pediatric Crohn's Disease Phase 4