Empagliflozin in Patients With Glomerulonephritis

Proteinuria Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05283057
• Other study ID #: KA-21-297
• Status: Completed
• Phase: Phase 3
• Start date: February 20, 2020
• Est. completion date: September 30, 2021

Study information

• Verified date: March 2022
• Source: Kasr El Aini Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 50
• Est. completion date: September 30, 2021
• Est. primary completion date: September 30, 2021
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years to 75 Years

Eligibility

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.

Related Conditions & MeSH terms

• Glomerulonephritis
• Proteinuria

Intervention

Drug:
• Empagliflozin 25 MG
single dose of the SGLT inhibitor Empagliflozin was given
• placebo
single dose of placebo that is similar to Empagliflozin in physical appearance

Locations

Country	Name	City	State
Egypt	Cairo university hospitals	Cairo

Sponsors (1)

Lead Sponsor	Collaborator
Kasr El Aini Hospital

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	protein to creatinine ratio	measurement of urinary protein to creatinine ratio as a marker of proteinuria	3 months
Secondary	Decline of glomerular filtration rate	Decline in estimated glomerular filtration rate over	3 months