Clinical trial NCT05283057: Empagliflozin in Patients With Glomerulonephritis
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE3
Conditions: Glomerulonephritis
Proteinuria
Keywords: sodium glucose cotransporter inhibitors
Empagliflozin
Lead sponsor: Kasr El Aini Hospital
Sponsor class: OTHER
First posted: 2022-03-16
Enrollment: 50
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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.

Primary outcomes:
measure: protein to creatinine ratio
timeFrame: 3 months
Secondary outcomes:
measure: Decline of glomerular filtration rate
timeFrame: 3 months
Other outcomes:
Locations:
city: Cairo
country: Egypt
facility: Cairo university hospitals
Study officials:
affiliation: Kasr Alainy faculty of medicine
name: Tarek Abdelaziz, PHD
role: PRINCIPAL_INVESTIGATOR
References: