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IRCT20150303021315N25 IRCT 2021-09-13 Nanoalvand Company Efficacy and safety evaluation of Suprotac® in comparison with Prograf® in prevention of liver transplant rejection Open-label, randomized study to evaluate efficacy and safety of Suprotac® in comparison with Prograf® in liver transplant patients in Iran 2021-09-06 anticipated 196 Complete https://irct.ir/trial/56321 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Eligible patients will be assigned to treatment using stratified block randomization with blocks of size 2 or 4. Randomization will be stratified according to living or deceased donors. The patients will be carried out using R-CRAN software version 3.6.3. Blocks will be made using permuted block randomization for a total of 196 patients (1:1 allocation ratio). The random series Excel will be placed in the patient recruitment center and a person will be responsible for assigning a random code by the investigator. This code will be assigned in order of entry and based on the stratification in which the patient's donor is living or deceased. 4 Liver transplant. Intervention 1: Intervention group: Suprotac® (Nanoalvand) is administered at a dose of 0.1–0.15 mg/kg orally on the first day post-transplant. Then, dose will be adjusted if needed to reach the desired trough level. Treatment is continued for one year. Intervention 2: Control group: Prograf® (Tacrolimus produced by Astellas Pharma) is administered at a dose of 0.1–0.15 mg/kg orally on the first day post-transplant. Then, dose will be adjusted if needed to reach the desired trough level. Treatment is continued for one year. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no intention for the company to do
public Nassim Anjidani
No 42, Attar Neyshaboori St., Vanak Sq., Tehran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 anjidani.n@orchidpharmed.com Orchid Pharmed scientific Nassim Anjidani
No 42, Attar Neyshaboori St., Vanak Sq., Tehran
Tehran Iran (Islamic Republic of) 1994766411 +98 21 4347 3000 anjidani.n@orchidpharmed.com Orchid Pharmed Iran (Islamic Republic of) Patient aged between 18 to 70 years Ability to comprehend and willing to sign the informed consent form for this study 18 years 70 years Both Use of other investigational drugs at the time or within 30 days of enrolment, or within five half-lives of those drugs, whichever is longer (except for dialysis-related drugs which are not expected to interact with the study regimens) Patients with contraindication for tacrolimus or any other ingredients of the formulation Patients with Glomerular Filtration Rate greater than 30 at the time of enrolment to the study Z94.4 Liver transplant status Treatment - Drugs Treatment - Drugs Intervention group: Suprotac® (Nanoalvand) is administered at a dose of 0.1–0.15 mg/kg orally on the first day post-transplant. Then, dose will be adjusted if needed to reach the desired trough level. Treatment is continued for one year. Control group: Prograf® (Tacrolimus produced by Astellas Pharma) is administered at a dose of 0.1–0.15 mg/kg orally on the first day post-transplant. Then, dose will be adjusted if needed to reach the desired trough level. Treatment is continued for one year. Transplantation rejection. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Liver transplant rejection approved by biopsy or clinical symptoms and laboratory tests (enhancement in alanine aminotransferase or aspartate aminotransferase liver enzymes). Death. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Incidence of death written in the adverse event’s section of the case report form. Graft loss. Timepoint: All along the study duration until one year after transplantation surgery. Method of measurement: Transplant rejection not responsive to the treatment according to the biopsy or clinical symptoms and laboratory tests (enhancement in alanine aminotransferase or aspartate aminotransferase liver enzymes). Mean trough concentration per dose of tacrolimus. Timepoint: Baseline, months 2, 4, 6 and 10. Method of measurement: Dividing trough concentration to the consumed daily dose. Adverse events. Timepoint: Baseline, months 2, 4, 6 and 10. Method of measurement: All adverse events are assessed through patient reporting, physician diagnosis, or laboratory abnormalities, and are then classified by severity (based on Common Terminology Criteria for Adverse Events (CTCAE)), seriousness, relationship to the study drug, action taken, and outcome. Nanoalvand Company Approved 2021-07-03 Research Ethics Committees of Shiraz University of Medical Sciences Zand Street Shiraz Fars Iran (Islamic Republic of)