Evaluation Renoprotective Effect SGLT2 inhibitors on Prognosis of Transplant Kidney Patients

Status

Active, not recruiting

Phases

Phase 3

Study type

Interventional

Source

IRCT

Registry ID

IRCT20220708055414N1

Enrollment

Registered

2023-02-19

Start date

2022-08-22

Completion date

Unknown

Last updated

2023-03-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Condition 1: Diabetes mellitus type 2. Condition 2: Transplant Kidney. Type 2 diabetes mellitus with kidney complications Kidney transplant status

Interventions

Intervention 1: Intervention group: The group that takes Empagloflozin tablets 10 mg daily for 24 weeks. Intervention 2: Control group: The group that takes Plasebo(lactose monohydrate) tablets daily

Eligibility

Sex/Gender

All

Age

18 Years to No maximum

Inclusion criteria

Inclusion criteria: Age>18 years old Stable state of renal function for at least the last three months Consent to participate in the study Sustained immunosuppressive therapy for at least three months Transplantation > one year ago Diabetic patient according to the criteria of the American Diabetes Association

Exclusion criteria

Exclusion criteria: Surgery or medical conditions that affect the rate of Absorption,Distribution and Metabolism or Excretion of the drug More than one transplant Pregnancy or Breastfeeding Allergy or Contraindications Type 1 diabetes Participation in any clinical study within 3 months before the initial dose GFR>45 Frequent UTI History of Alcohol use in the 12 months prior to the initial dose Donating blood or Removing 400 ml of blood is required 8 weeks before the initial dose

Design outcomes

Primary

Measure	Time frame
Function of transplant kidney. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Glomerular filteration rate-Creatinine(lab test).	—

Secondary

Measure	Time frame
FBS. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hb A1C. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hemoglobin. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hematocrite. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Uric acid. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Na. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Potasium. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.	—

Measure

Time frame

FBS. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hb A1C. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hemoglobin. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Hematocrite. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Uric acid. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Na. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.;Potasium. Timepoint: At the beginning of the study-End of 8th 16th 24th week. Method of measurement: Laboratory biochemical tests.

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Countries

Iran (Islamic Republic of)

Contacts

Public ContactFatemeh Jalali

Tehran University of Medical Sciences

shariatihosp@tums.ac.ir+98 21 8490 1000

Outcome results

None listed

Source: IRCT (via WHO ICTRP) · Data processed: Feb 4, 2026