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New treatment option for Chronic Kidney Failure
Official title Belatacept as a Replacement for CNIs 3 to 12 Months Post-transplantation in Patients With Early Graft Dysfunction
ClinicalTrials.gov ID: NCT05562869
What this study is testing
What is Belatacept 250 Milligram Intravenous Powder for Solution?
Belatacept 250 Milligram Intravenous Powder for Solution is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for chronic kidney failure.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 3: a large, late-stage study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 to 99
You may be able to join if
- 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.
You likely can't join if
- Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation.
- seropositivity for HIV
- another history of other solid organ transplants (outside the kidney)
- primary non-function (persistence of a need for dialysis at 3 months post-transplantation)
- participation in progress to another treatment clinical study
- any clinical condition that the investigator considers incompatible with the course of the study.
See the full eligibility criteria
- 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
- Presence of Donor Specific Antibody during kidney transplant or appeared at 3 months post-transplantation.
- seropositivity for HIV
- another history of other solid organ transplants (outside the kidney)
- primary non-function (persistence of a need for dialysis at 3 months post-transplantation)
- participation in progress to another treatment clinical study
- any clinical condition that the investigator considers incompatible with the course of the 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
The study team makes the final eligibility decision.
Where it's taking place
- Nantes, Loire Atlantique, France
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years to 99 years. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Nantes, Loire Atlantique, France. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.