PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus

• Status: Recruiting
• Trial end date: 2024-03-15
• Target enrollment: 0
• Participant gender: All

Summary

The investigators believe that the pharmacological properties of Envarsus®, well studied in kidney transplantation, may be also suitable after simultaneous kidney and pancreas transplantation than Prograf. Indeed, Envarsus® has demonstrated a clinical efficacy and safety in a complete clinical development plan.

This study is to establish the pharmacokinetic profile of tacrolimus prolonged-release (hereafter referred to as 'ENVARSUS®') in diabetics who have undergone kidney and pancreas transplantation, and compare it to the pharmacokinetic profile of standard twice-daily tacrolimus. The study will be conducted in 25 patients hospitalized at Nantes University Hospital.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Nantes University Hospital
• Collaborator: Chiesi Farmaceutici S.p.A.
• Treatments: Tacrolimus

Criteria

Inclusion Criteria:

• Patient is willing and able to give informed consent for participation in the trial.

• Male or Female, aged 18 years or above.

• Type I Diabetics patients with end stage chronic renal failure

• Recipient of kidney and pancreas-transplant

• Both transplants are functioning at time of PK profile measurements

• Standard immunosuppressive therapy has been started post-operatively, in accordance with local policy, including tacrolimus.

• In the Investigator's opinion, is able and willing to comply with all trial requirements.

• Patients with social security.

Exclusion Criteria:

The participant may not enter the trial if ANY of the following apply:

• Patient is inappropriate for standard immunosuppressive therapy.

• Any other significant disease or disorder which, in the opinion of the Investigator, may either put the patients at risk because of participation in the trial, or may influence the result of the trial, or the patient's ability to participate in the trial.

• Concomitant therapy with drugs potentially interfering with tacrolimus pharmacokinetics, especially those interfering with CYP3A4 (see 4.4 section in tacrolimus / ENVARSUS® summary of product characteristics).

• Pregnant or breast-feeding women and female patient with potential childbearing refusing contraception.

• Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship.