Empagliflozin in Patients With Glomerulonephritis

NCT ID: NCT05283057

Last Updated: 2022-03-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE3
• Total Enrollment: 50 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2020-02-20
• Study Completion Date: 2021-09-30

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.

Conditions

Glomerulonephritis; Proteinuria

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: TRIPLE

Study Groups

Group 1: Empagliflozin

25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin

Group Type: ACTIVE_COMPARATOR

Empagliflozin 25 MG

Intervention Type: DRUG

single dose of the SGLT inhibitor Empagliflozin was given

Group 2:

25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo

Group Type: PLACEBO_COMPARATOR

placebo

Intervention Type: DRUG

single dose of placebo that is similar to Empagliflozin in physical appearance

Interventions

Empagliflozin 25 MG

single dose of the SGLT inhibitor Empagliflozin was given

Intervention Type: DRUG

placebo

single dose of placebo that is similar to Empagliflozin in physical appearance

Intervention Type: DRUG

Other Intervention Names

EMPA; PLAC

Eligibility Criteria

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.

• Minimum Eligible Age: 18 Years
• Maximum Eligible Age: 75 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Kasr El Aini Hospital

OTHER

Sponsor Role: lead

Responsible Party

Tarek Samy Abdelaziz

Professor

Responsibility Role: PRINCIPAL_INVESTIGATOR

Principal Investigators

Tarek Abdelaziz, PHD

Role: PRINCIPAL_INVESTIGATOR

Kasr Alainy faculty of medicine

Locations

Cairo university hospitals

Cairo, , Egypt

Countries

Egypt

Other Identifiers

KA-21-297

Identifier Type: -

Identifier Source: org_study_id