Graft Acute Kidney Injury: Vitamin B3 to Facilitate Renal Recovery In the Early Life of a Transplant

• Status: Not yet recruiting
• Trial end date: 2023-09-01
• Target enrollment: 0
• Participant gender: All

Summary

Delayed graft function occurs in more than 20% of kidney transplantations. It is an episode of post-ischemic acute kidney injury with long-term consequences on the allograft's function. Based on preclinical data and on a stage 1 clinical trial, we hypothesize that an acquired defect in NAD+ biosynthesis is instrumental in delayed graft function and that a treatment with high doses of vitamin B3 (nicotinamide) will improve the early renal graft function.

Thus, we plan to recruit 204 kidney allograft recipients immediately before transplantation and randomize them to either placebo or nicotinamide treatment for 3 administrations before transplantation, immediately after it and on the next day.

We will judge on the efficacy of nicotinamide to foster early graft function by comparing the creatinine reduction ratio between the placebo and the nicotinamide treated groups.

We will collect serum before and 2 days after transplantation and urine 2 days and 3 months after transplantation to study the relationship between biological markers of NAD+ biosynthesis and nicotinamide's effect on early kidney graft function.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Assistance Publique - Hôpitaux de Paris
• Collaborators: Centre National de la Recherche Scientifique, France; Institut National de la Santé Et de la Recherche Médicale, France
• Treatments: Niacin; Niacinamide; Nicotinic Acids

Criteria

Inclusion Criteria:

• Age ≥18 years,

• Patients in end stage renal disease (ESRD) requiring dialysis (hemodialysis or peritoneal dialysis),

• Kidney transplant with deceased donor (brain death or cardiac death Maastricht 3),

• Affiliation to French social security ("AME" excepted),

• Written informed consent

Exclusion Criteria:

• Preemptive transplant,

• Pregnancy,

• Liver disease defined by the necessity for a specialized follow-up by an hepatologist or by elevated liver enzymes > 3N (ALAT, gammaGT) on the day of transplantation,

• Transplantation of multiple organs,

• Hypersensitivity to nicotinamide or one of excipients,

• Participation to another interventional study (RIPH1),

• Patient under legal protection measure (tutorship or curatorship) and patient deprived of freedom.