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IRCT20211104052965N1 IRCT 2022-09-06 Shahid Beheshti University of Medical Sciences Effect of empagliflozin on renal events in non-diabetic chronic kidney disease patients Investigating the effect of empagliflozin on renal events in non-diabetic chronic kidney disease patients with and without proteinuria. A double-blind placebo-controlled randomized clinical trial study 2022-09-23 anticipated 458 Complete https://irct.ir/trial/65344 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: Patients will be randomized by simple individual randomization through https://www.sealedenvelope.com/simple-randomiser/v1/lists. Tablets are delivered to patients in sealed envelopes with drug and placebo codes, Blinding description: Patients and health care provider who visit the patient and deliver the pills to the patient are completely blinded through the sealed and coded medicine envelope, and the person who packed the envelopes and designed the codes in Performance does not matter. 4 Chronic kidney disease. The intervention group, patients are treated with empagliflozin tablets manufactured by Alhavi Pharmaceutical Company with a dose of 10 mg daily in the morning after breakfast. The medicine is delivered to the patients in opaque bottles.. Yes - There is a plan to make this available What will be shared: All demographic, laboratory and clinical interview information and results will be provided anonymously When: After the article is published To whom: Information will be available to researchers of scientific institutions Conditions: The data can be accessed by the authors in compliance with the copyright Where to obtain: People can email hosseinamini96@yahoo.com and submit their request How to obtain: After stating the reason for the need for access, the data will be shared Comments:
public Tahereh Sabaghian
Imam Hossein hospital, Shahid Madani street
Tehran Iran (Islamic Republic of) 1617763141 +982173430 ph.sabaghian@gmail.com Shahid Beheshti University of Medical Sciences scientific Tahereh Sabaghian
Imam Hossein hospital, Shahid Madani street
Tehran Iran (Islamic Republic of) 1617763141 +982173430 ph.sabaghian@gmail.com Shahid Beheshti University of Medical Sciences Iran (Islamic Republic of) Patients over 18 years old Patients with 20≤eGFR≤75 mL/min/1.73m2 (calculated by MDRD formula) at the first visit 18 years 75 years Both Dominant or autosomal recessive polycystic kidney disease, lupus nephritis or vasculitis with anti-neutrophil cytoplasmic antibody (ANCA) Received cytotoxic therapy, immunosuppressive therapy, or other immunologic therapy for primary or secondary renal disease within 6 months prior to the first visit Organ transplant history Blood pressure less than 90/60 mmHg Treatment with a sodium glucose cotransporter (SGLT 2) inhibitor within 8 weeks before the first visit or previous drug intolerance Frequent UTI Type 1 and 2 diabetes Class (NYHA) IV congestive heart failure at first visit Myocardial infarction, unstable angina, stroke and transient ischemic attack (TIA) within 12 weeks before the first visit Cardiovascular interventions such as CABG, PCI and valve replacement or repair within 12 weeks before the first visit Conditions such as malignancies where the patient does not have a good prognosis based on the clinical judgment of the researcher Active malignancy at the first visit Liver failure (AST and ALT more than three times normal and total bilirubin more than twice normal) Women prone to pregnancy who do not use contraceptive methods Pregnancy and breastfeeding Candida infection and low hygiene N18 Chronic kidney disease (CKD) Treatment - Drugs The intervention group, patients are treated with empagliflozin tablets manufactured by Alhavi Pharmaceutical Company with a dose of 10 mg daily in the morning after breakfast. The medicine is delivered to the patients in opaque bottles. The reduction of microalbuminuria. Timepoint: The second, fourth and sixth months after starting the study. Method of measurement: Laboratory measurement of albumin to creatinine ratio in random urine samples. Does the patient experience an increase in the ratio of albumin to creatinine in the random urine sample or not?. Timepoint: The second, fourth and sixth months after starting the study. Method of measurement: Laboratory measurement of albumin to creatinine ratio in random urine samples. Checking the patient's GFR through the MDRD formula every two months. Timepoint: The second, fourth and sixth months after starting the study. Method of measurement: Laboratory measurement of serum creatinine and calculation of GFR through the MDRD formula. The patient's condition in terms of high blood pressure and the use of antihypertensive drugs. Timepoint: The second, fourth and sixth months after starting the study. Method of measurement: Direct measurement of blood pressure. Investigation of drug side effects such as urinary tract infection. Timepoint: The second, fourth and sixth months after starting the study. Method of measurement: Clinical interview. Shahid Beheshti University of Medical Sciences Approved 2022-07-24 Ethics Committee of Shahid Beheshti University of Medical Sciences Ethics Committee of Shahid Beheshti University of Medical Sciences, next to Ayatollah Taleghani Hospital, Shahid Aarabi street, Velenjak, Tehran, Iran. Tehran Tehran Iran (Islamic Republic of)