Empagliflozin in Patients With Glomerulonephritis

Phase 3

Completed

• Conditions: Glomerulonephritis; Proteinuria
• Interventions: Drug: Empagliflozin 25 MG; Drug: placebo

• Registration Number: NCT05283057
• Lead Sponsor: Kasr El Aini Hospital

Brief Summary

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes. one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.

Detailed Description

Sodium-glucose cotransporter 2 (SGLT2) inhibitors are newly developed antihyperglycemic medications. In addition to their glucose lowering properties, they have been shown to have favourable effects on the cardiovascular and renal outcome in patients with diabetes.The favourable cardiovascular effects include increased diuresis , reduction of blood pressure and reduction of hospitalisation for heart failure one of the most interesting renal effects is reduction of proteinuria. The aim of our study was examine the effect of SGLT inhibitors on proteinuria in patients with glomerulonephritis. This study is a randomised controlled trial.

Study Timeline

• Study Start: 2020-02-20
• Primary Completion: 2021-09-30
• Study Completion: 2021-09-30
• Status Verified: 2022-03
• Study First Submitted: 2022-03-07
• Study First Submitted QC: 2022-03-07
• Last Update Submitted: 2022-03-07
• Study First Posted: 2022-03-16
• Last Update Posted: 2022-03-16

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 50

Inclusion Criteria

1. Age ≥18 and ≤75 years.
2. Urinary protein excretion > 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
3. On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
4. Who signed informed consent.
5. Women of Child-Bearing Potential (WOCBP) used an acceptable method of contraception to avoid pregnancy throughout the study and for up to 4 weeks after the last dose of study drug in such a manner that the risk of pregnancy was minimized.

Exclusion Criteria

• a) Diagnosis of type 1 or type 2 diabetes mellitus b) Urinary protein excretion of less than 500 mg/g and eGFR < 30 ml/min

  • 1.7m2 c) Active malignancy d) Any medication, surgical or medical condition that may significantly alter the absorption, distribution, metabolism, or excretion of medications including, but not limited to any of the following: History of active inflammatory bowel disease within the last six months; Major gastrointestinal tract surgery such as gastrectomy, gastroenterostomy, or bowel resection; Gastro-intestinal ulcers and/or gastrointestinal or rectal bleeding within last six months; Pancreatic injury or pancreatitis within the last six months.

    e) Evidence of hepatic disease as determined by any one of the following: ALT or AST values exceeding 3x ULN at the screening visit, a history of hepatic encephalopathy, a history of esophageal varices, or a history of portocaval shunt.

    f) Evidence of urinary tract obstruction. g) History of hypersensitivity or contraindications to empagliflozin. h) Subject who, in the assessment of the investigator, may be at risk for dehydration or volume depletion that may affect the interpretation of efficacy or safety data.

    i) Participation in any clinical investigation within 3 months prior to initial dosing.

    j) History of noncompliance to medical regimens or unwillingness to comply with the study protocol.

    k) Pregnancy or breastfeeding.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Group 1: Empagliflozin	Empagliflozin 25 MG	25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin
Group 2:	placebo	25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo

Primary Outcome Measures

Name	Time	Method
protein to creatinine ratio	3 months	measurement of urinary protein to creatinine ratio as a marker of proteinuria

Secondary Outcome Measures

Name	Time	Method
Decline of glomerular filtration rate	3 months	Decline in estimated glomerular filtration rate over

Trial Locations

Locations (1)

Cairo university hospitals; 🇪🇬 Cairo, Egypt