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IRCT20101106005113N4 IRCT 2025-06-05 Dr. Abidi Pharmaceuticals Safety and Effectiveness of SGLT2 Inhibitors in Kidney Transplantation Patients Clinical trial of evaluation of the safety and effectiveness of SGLT2 inhibitors in new kidney transplant patients 2025-05-22 anticipated 60 Complete https://irct.ir/trial/83706 interventional Randomization: Randomized, Blinding: Not blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization Approach: Restricted Randomization using Block Randomization. Purpose of Blocking: To balance the number of participants between the intervention group and the control group. Block Configuration: Create 6 blocks, each containing 10 participants (with 5 participants assigned to the intervention group and 5 to the control group within each block). Random Selection of Blocks: Use random number generation tools, like the R programming language, to generate 6 random numbers within the range of 1 to 6. Application of Sealed Envelopes: Record the random sequences on cards and store them in opaque, sealed envelopes, arranged in numerical order. 1-2 Kidney Transplant. Intervention 1: Intervention group: Following kidney transplantation and stabilization of kidney function, indicated by a steady serum creatinine level at discharge, the patient will receive a daily dose of 10 mg Empagliflozin from Abidi Pharmaceutical Company for three months, in conjunction with the immunosuppressive regimen. Intervention 2: Control group: Only received an immunosuppressed protocol and did not receive any intervention. Yes - There is a plan to make this available What will be shared: The data obtained from the primary and secondary outcomes of the study will first be provided to the Nephrology Research Center of the university for use by other researchers. Secondly, it will be shared with the funding company to be sent to its central organization (Abidi Pharmaceutical Company) so that international researchers can access this data. Finally, the results of the study will be published as an article. When: The access period begins 1 months after the results are published. To whom: researchers in the field of medicine and pharmacology Conditions: The use of documents for writing scientific articles or research reports is permitted with proper citation (including the IRCT registration code and the names of the researchers) and contingent upon obtaining written permission from the Nephrology Research Center of Tehran University of Medical Sciences. Where to obtain: M R Khatami, Nephrology Research Center, Imam Khomeini hospital khatamis@sina.tums.ac.ir How to obtain: The requests should be sent to Nephrology Research Center, by the name of main researcher and after the evaluation of position of the requester the data will be available for him/her. Comments:
public Mohammad Reza Khatami
Keshavarz Blvd.
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2085 khatamis@sina.tums.ac.ir Tehran University of Medical Sciences scientific Mohammad Reza Khatami
Keshavarz Blvd
Tehran Iran (Islamic Republic of) 1419733141 +98 21 6119 2085 khatamis@sina.tums.ac.ir Tehran University of Medical Sciences Iran (Islamic Republic of) New Kidney Transplant Age group 18 to 75 years old Able to adhere to the studied medication regimen (no drug sensitivity or previous contraindications) 18 years 75 years Both Empagliflozin sensitivity Diabetes Mellitus type 1 Urosepsis Informed Consent Refusal Glomerular filtration rate (GFR) of less than 20 mL/min. Z94.0 Kidney transplant status Treatment - Drugs Other Intervention group: Following kidney transplantation and stabilization of kidney function, indicated by a steady serum creatinine level at discharge, the patient will receive a daily dose of 10 mg Empagliflozin from Abidi Pharmaceutical Company for three months, in conjunction with the immunosuppressive regimen. Control group: Only received an immunosuppressed protocol and did not receive any intervention. Glomerular filtration rate. Timepoint: Patients will be evaluated at the beginning of the study, as well as one month and three months after initiating treatment with Empagliflozin 10 mg. Method of measurement: MDRD equation. HbA1C. Timepoint: before intervention and 1, 3 , month after intervention. Method of measurement: Laboratory test. Urinary tract infections. Timepoint: before intervention and 1, 3 , month after intervention. Method of measurement: Urine Culture media. Microalbuminuria. Timepoint: before intervention and 1, 3 , month after intervention. Method of measurement: Random urine Albumin to Creatinine ratio. Acute Transplant Rejection. Timepoint: before intervention and 1, 3 , month after intervention. Method of measurement: Transplanted Kidney Biopsy. Dr. Abidi Pharmaceuticals Approved 2025-05-20 Imam Khomeini Hospital Complex, Tehran University of Medical Sciences (Research Ethics Committee) Tehran, at the end of Keshavarz Boulevard, Imam Khomeini Hospital, Kidney Transplant Department. tehran Tehran Iran (Islamic Republic of)