Effect of empagliflozin on renal events in non-diabetic chronic kidney disease patients

Phase 4

Recruiting

• Conditions: Chronic kidney disease.; Chronic kidney disease (CKD)

• Registration Number: IRCT20211104052965N1
• Lead Sponsor: Shahid Beheshti University of Medical Sciences

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 21 November 2022

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 458

Inclusion Criteria

Patients over 18 years old
Patients with 20=eGFR=75 mL/min/1.73m2 (calculated by MDRD formula) at the first visit

Exclusion Criteria

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

Study & Design

• Study Type: interventional
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
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.

Secondary Outcome Measures

Name	Time	Method
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.