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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

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
IRCT
Registry ID
IRCT20211104052965N1
Enrollment
458
Registered
2022-09-06
Start date
2022-09-23
Completion date
Unknown
Last updated
2022-11-21

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

Conditions

Chronic kidney disease. Chronic kidney disease (CKD)

Interventions

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 deliver

Sponsors

Shahid Beheshti University of Medical Sciences
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 75 Years

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
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.

Countries

Iran (Islamic Republic of)

Contacts

Public ContactTahereh Sabaghian

Shahid Beheshti University of Medical Sciences

ph.sabaghian@gmail.com+982173430

Outcome results

None listed

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