Status:
COMPLETED
PK Study in Diabetic Transplant récipients : From Twice-daily Tacrolimus to Once-daily Extended-release Tacrolimus
Lead Sponsor:
Nantes University Hospital
Collaborating Sponsors:
Chiesi Farmaceutici S.p.A.
Conditions:
Kidney Transplantation
Pancreas Transplantation
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief 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 Pro...
Detailed Description
The study will be conducted in 25 patients hospitalized at Nantes University Hospital. Tacrolimus will be started on the day of surgery (or on the day after) according to Nantes local standard doses a...
Eligibility Criteria
Inclusion
- 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
- At least one of the two transplants are functioning at time of PK profile measurements : a patient with early pancreatic graft failure due to thrombosis may be included if the kidney is well functioning
- 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
- 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).
- Loss of the pancreatic graft due to immunological causes
- Pregnant or breast-feeding women and female patient with potential childbearing refusing contraception.
- Vulnerable people: persons deprived of liberty; under trusteeship or under curatorship.
Key Trial Info
Start Date :
September 28 2020
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 7 2023
Estimated Enrollment :
25 Patients enrolled
Trial Details
Trial ID
NCT04496401
Start Date
September 28 2020
End Date
November 7 2023
Last Update
December 14 2023
Active Locations (1)
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1
Nantes University Hospital
Nantes, France, 44093