NCT05562869RecruitingPhase 3
Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
Source: ClinicalTrials.gov · Last updated 9 May 2024 · Not updated for over 12 months - ask the site whether it is still open
Brief summary (registry, in English)
Calcineurin inhibitors (CNI) remain the standard treatment in renal transplantation to prevent rejection. Currently the main limitation of kidney transplantation is the occurrence of chronic graft dysfunction due to the CNI nephrotoxicity. Thus, strategies to minimize or stop CNI have been developed as belatacept, a fusion protein (CTLA4-Ig) blocking the ligand of the main CD28 costimulatory molecule. In the original phase III trial, used de novo in combination with MMF (without CNI) belatacept allowed to obtain a better renal function as soon as 1 year and a better graft and patient survival after 7 years. Despite these excellent results, belatacept has not become the gold standard due to a higher incidence of early rejection. In addition, belatacept is not covered by the french social security policy, because benefits are considered insufficient with respect to the cost. Patients with poor early graft function are a preferred indication of belatacept. It is then used instead of CNI at 3 months post-transplant allowing to improve kidney function without over-risk of rejection. Currently after conversion, belatacept is maintained indefinitely due to the supposed CNI chronic nephrotoxicity. However this one is more and more questionable. Thus, the investigators assume that in patients with poor function at 3 months posttransplantation the belatacept's benefit could be obtained by a transient replacement of CNI by belatacept from 3 to 12 months post-transplantation. It is the feasibility of this strategy and its medico-economic impact that the investigators wish to study.
- Status (registry)
- Recruiting
- Phase (registry)
- Phase 3
- Study type
- Interventional
- Enrollment
- 30 (estimated)
- First submitted
- 28 Sept 2022
- Start date
- 3 May 2024
- Primary completion date
- 3 May 2027
- Lead sponsor
- Nantes University Hospital
- Diseases
- Chronic kidney disease
- NCT number
- NCT05562869
What you commit to
- Study type: Interventional · Phase 3
- Planned participants: 30
- From 3 May 2024 to the primary completion date, 3 May 2027
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation.
- primary non-function (persistence of a need for dialysis at 3 months post-transplantation)
Other illness
- seropositivity for HIV
- another history of other solid organ transplants (outside the kidney)
- any clinical condition that the investigator considers incompatible with the course of the study.
Other
- participation in progress to another interventional clinical study
- contraindication to belatacept and Tacrolimus
- Pregnant or breastfeeding woman
- Inability of the patient to comply with study procedures
- Person placed under guardianship or curatorship, under safeguard of justice
Who the study is looking for
- adult older than 18 years old.
- transplantation of a deceased or living donor kidney (non-human leukocyte antigen(HLA)-identical) with blood type (ABO) compatibility
- no contraindication to the protocol graft biopsy (10 weeks post transplant)
- treatment by CNI / MPA +/- prednisone
- renal function estimated by creatinine clearance according to CKD-EPI \<30 ml / min / 1.73m2.
- having no difficulty in understanding and communicating with the investigator and his representatives.
- Agreeing to give informed written consent
- benefiting from a Social Security policy.
- results of the 10-week post-transplant renal biopsy finding no rejection or BK virus (member of the polyomavirus family) nephropathy, no recurrence, no thrombotic microangiopathy, no cortical necrosis.
- Seropositivity for Epstein-Barr virus (EBV)
- negative pregnancy test and agreement on the use of effective contraception throughout the study
Age in the registry: 18 years to 99 years · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| CHU Nantes Coordinator of this site? Confirm its status | Nantes | France | Recruiting |
This page is information, not medical advice. Discuss any trial with your doctor.