Phase 3 Chronic Kidney Disease Trial, Recruiting NCT05562869 Sponsor: Nantes University Hospital Condition: Chronic Kidney Disease
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Phase 3 Chronic Kidney Disease Trial, Recruiting

NCT05562869
Recruiting Phase 3

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

Who might be able to join this trial:

  • Adults aged 18 or older
  • People who have received a kidney transplant from a deceased or living donor, where the donor and recipient are not a full genetic (HLA) match, and where blood types are compatible
  • People whose kidney function (measured by a specific calculation called CKD-EPI) is below 30 ml/min/1.73m²
  • People currently taking a specific combination of anti-rejection medications known as CNI and MPA, with or without prednisone (a steroid)
  • People whose 10-week post-transplant kidney biopsy showed no signs of rejection, no BK virus infection, no disease recurrence, no blood vessel complications, and no tissue death
  • People who have previously been exposed to the Epstein-Barr virus (EBV), confirmed by a blood test
  • People who are able to understand and communicate with the research team
  • People who agree to provide written consent to participate
  • People covered by a French Social Security policy
  • People with no medical reason preventing a kidney biopsy at 10 weeks after transplant
  • People who return a negative pregnancy test and agree to use effective contraception throughout the study

Who may not be able to join:

  • People who have developed antibodies specifically targeting their donor's tissue (called Donor Specific Antibodies), either at the time of transplant or within the first 3 months after
  • People who are HIV positive
  • People who have previously received another solid organ transplant (other than a kidney)
  • People whose transplanted kidney never began working and who still require dialysis at 3 months after transplant
  • People currently taking part in another interventional clinical trial
  • People whose overall health condition the trial doctor considers incompatible with taking part in the study
  • People who have a medical reason preventing them from taking the study medications belatacept or tacrolimus
  • People who are pregnant or breastfeeding
  • People who would be unable to follow the study procedures as required
  • People who are under legal guardianship, court protection, or a similar legal arrangement

Important: Always verify eligibility with the trial site directly before applying.

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 27 July 2026
Phase 3: approximately ~65% of drugs entering this phase reach regulatory approval, based on published industry-wide historical data. This is not specific to this trial.
Phase success rates shown are historical industry-wide averages based on published data. They are not a prediction for this specific trial or your individual situation.

Contact this trial

Phone: 0240087453

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

Print a one-page summary to share with your doctor.

Trial details

Status
Recruiting
Phase
Phase 3
Registry
ClinicalTrials.gov
Start date
3 May 2024
Est. completion
3 May 2027

Where this trial is recruiting

🇫🇷 France

Primary endpoints

Feasibility of a transient replacement of CNIs by belatacept in renal transplant patients with early graft dysfunction. Creatinine clearance did not decrease by more than 25% from the cessation of belatacept 6 months after reintroduction of CNI.

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 27 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov