Empagliflozin in Patients With Glomerulonephritis

• Sponsor: Kasr El Aini Hospital (Other)
• Overall Status: Completed
• CT.gov ID: NCT05283057
• Collaborator: (none)
• Enrollment: 50
• Location: 1
• Arms: 2
• Actual Duration (Months): 19.3
• Patients Per Site Per Month: 2.6

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Glomerulonephritis; Proteinuria	Drug: Empagliflozin 25 MG; Drug: placebo	Phase 3

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 Design

• Study Type: Interventional
• Actual Enrollment: 50 participants
• Allocation: Randomized
• Intervention Model: Parallel Assignment
• Masking: Triple (Participant, Care Provider, Investigator)
• Primary Purpose: Treatment
• Official Title: Effect of Sodium Glucose Transporter 2 Inhibitor Empagliflozin on Proteinuria and Kidney Disease Progression in Patients With Non-diabetic Glomerulonephritis- A Randomized Controlled Trial
• Actual Study Start Date: Feb 20, 2020
• Actual Primary Completion Date: Sep 30, 2021
• Actual Study Completion Date: Sep 30, 2021

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: Group 1: Empagliflozin 25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin	Drug: Empagliflozin 25 MG; single dose of the SGLT inhibitor Empagliflozin was given; Other Names: EMPA
Placebo Comparator: Group 2: 25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo	Drug: placebo; single dose of placebo that is similar to Empagliflozin in physical appearance; Other Names: PLAC

Outcome Measures

Primary Outcome Measures

1. protein to creatinine ratio [3 months]

   measurement of urinary protein to creatinine ratio as a marker of proteinuria

Secondary Outcome Measures

1. Decline of glomerular filtration rate [3 months]

   Decline in estimated glomerular filtration rate over

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years to 75 Years
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

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:

• 1. 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.

1. 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.

2. 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.

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

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

5. Pregnancy or breastfeeding.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Cairo university hospitals	Cairo		Egypt

Sponsors and Collaborators

• Kasr El Aini Hospital

Investigators

• Principal Investigator: Tarek Abdelaziz, PHD, Kasr Alainy faculty of medicine

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

• Responsible Party: Tarek Samy Abdelaziz, Professor, Kasr El Aini Hospital
• ClinicalTrials.gov Identifier: NCT05283057
• Other Study ID Numbers: KA-21-297
• First Posted: Mar 16, 2022
• Last Update Posted: Mar 16, 2022
• Last Verified: Mar 1, 2022

• Studies a U.S. FDA-regulated Drug Product: No
• Studies a U.S. FDA-regulated Device Product: No
• Keywords provided by Tarek Samy Abdelaziz, Professor, Kasr El Aini Hospital: sodium glucose cotransporter inhibitors; Empagliflozin
• Additional relevant MeSH terms: Proteinuria; Glomerulonephritis; Empagliflozin

Study Results

No Results Posted as of Mar 16, 2022