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IRCT20230909059387N1 IRCT 2026-02-07 Shiraz University of Medical Sciences Tacrolimus with extended release in kidney transplant Comparison of efficacy and safety of extended-release versus immediate-release tacrolimus in renal transplant patients: a double-blind randomized controlled trial 2026-02-20 anticipated 200 Complete https://irct.ir/trial/88647 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Participants will be randomly allocated in a 1:1 ratio to one of two treatment groups using block randomization with permuted blocks of four. The six possible block permutations (AABB, ABAB, ABBA, BBAA, BABA, BAAB) will be used. Random numbers will be generated from a random number table, with numbers 1–6 corresponding to the block permutations; numbers 0, 7, 8, and 9 will be disregarded. Randomization will continue until the full sample size is assigned. The unit of randomization will be the individual participant. No stratified randomization will be applied. The randomization sequence will be generated in advance and used at enrollment. Allocation concealment will be maintained using the pre-generated randomization sequence, Blinding description: This study is conducted as a double-blind randomized controlled trial. Study participants are blinded to treatment allocation and are not informed whether they receive extended-release tacrolimus (Advagraf®) or immediate-release tacrolimus (Prograf®). The principal investigator and all healthcare providers involved in patient care, including physicians and nurses, are blinded to group assignment throughout the study period. Randomization is performed using a pre-generated allocation sequence, which is kept confidential and is not accessible to investigators, healthcare providers, data collectors, or outcome assessors. 3 Kidney transplantation in adult recipients receiving tacrolimus based immunosuppressive therapy during the early post transplantation period.. Intervention 1: Intervention group: Participants receive once daily extended release tacrolimus (Advagraf®, Astellas) at a starting dose of 5 milligrams per day as part of a standardized immunosuppressive regimen including anti-thymocyte globulin induction, oral prednisolone tapering, and either mycophenolate mofetil or mycophenolic acid. Dose adjustments are based on target trough blood levels of 8 to 10 nanograms per milliliter. Intervention 2: Control group: Participants receive twice daily immediate release tacrolimus (Prograf®, Astellas) at a starting dose of 2 milligrams twice daily in the same standardized immunosuppressive regimen. Dose adjustments are based on target trough blood levels of 8 to 10 nanograms per milliliter. Yes - There is a plan to make this available What will be shared: Deidentified individual participant data set including demographic variables, baseline clinical characteristics, intervention assignment, primary and secondary outcome measures collected during the first month after kidney transplantation. When: The data will become available starting a few months after publication of the main study results To whom: Deidentified data will be available to qualified researchers affiliated with academic or research institutions. Conditions: Data will be shared for scientific research purposes only. Requests must include a clear research proposal and will be reviewed by the principal investigator. Data use is limited to analyses consistent with the approved proposal. Where to obtain: Requests should be submitted via email to the principal investigator at Shiraz University of Medical Sciences. Communication will be conducted primarily by email. Email: nakisarasaei@gmail.com How to obtain: Applicants must submit a written request including study objectives and analysis plan. Requests will be reviewed within approximately 2 weeks, and approved data will be shared after signing a data use agreement. Comments:
public Nakisa Rasaei
Internal ward office, Namazi Hospital, Namazi square, Shiraz
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 nakisarasaei@gmail.com Shiraz University of Medical Sciences scientific Nakisa Rasaei
Internal ward office, Namazi Hospital, Namazi square, Shiraz
Shiraz Iran (Islamic Republic of) 7193613311 +98 71 3612 5000 nakisarasaei@gmail.com Shiraz University of Medical Sciences Iran (Islamic Republic of) All patients at this center have received a kidney transplant from a deceased and brain-dead donor Adult recipients (age ≥ 18 years) undergoing their first kidney transplant. Willingness and ability to provide written informed consent as they are to receive a tacrolimus-based immunosuppressive regimen. 18 years no limit Both Recipients of multiple organ transplants Patients undergoing retransplantation Known sensitivity to tacrolimus or its excipients ABO blood group incompatible transplant Pregnant or lactating women Desire to use a specific dosage form of Tacrolimus Z94.0 Kidney transplant status Treatment - Drugs Treatment - Drugs Intervention group: Participants receive once daily extended release tacrolimus (Advagraf®, Astellas) at a starting dose of 5 milligrams per day as part of a standardized immunosuppressive regimen including anti-thymocyte globulin induction, oral prednisolone tapering, and either mycophenolate mofetil or mycophenolic acid. Dose adjustments are based on target trough blood levels of 8 to 10 nanograms per milliliter. Control group: Participants receive twice daily immediate release tacrolimus (Prograf®, Astellas) at a starting dose of 2 milligrams twice daily in the same standardized immunosuppressive regimen. Dose adjustments are based on target trough blood levels of 8 to 10 nanograms per milliliter. Incidence of biopsy proven acute rejection within the first month after kidney transplantation. Timepoint: During the first four weeks after kidney transplantation. Method of measurement: For cause kidney biopsy performed in cases of suspected acute rejection or unexplained increase in serum creatinine, with histopathological confirmation by a transplant pathologist. Renal graft function assessed by serum creatinine level. Timepoint: Day 1, Day 2, Week 1, Week 2, Week 3, and Week 4 after kidney transplantation. Method of measurement: Serum creatinine measured using standard laboratory methods. Shiraz University of Medical Sciences Approved 2025-12-24 Ethics committee of shiraz university of medical sciences Imam Hossein Square, Zand Street, Shiraz Shiraz Fars Iran (Islamic Republic of)