Empagliflozin in Patients With Glomerulonephritis
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 Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Study Type
Enrollment (Actual)
Phase
- Phase 3
Contacts and Locations
Study Locations
-
-
-
Cairo, Egypt
- Cairo university hospitals
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-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- Age ≥18 and ≤75 years.
- Urinary protein excretion > 500 mg/g and eGFR ≥ 30 mL/min/1.73 m2 (CKD stages 1-3).
- On a stable dose of an ACEi or ARBs together with their immunosuppression protocol for at least 4 weeks prior to randomization.
- Who signed informed consent.
- 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 Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
|---|---|
|
Active Comparator: Group 1: Empagliflozin
25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin
|
single dose of the SGLT inhibitor Empagliflozin was given
Other Names:
|
|
Placebo Comparator: Group 2:
25 patients with glomerulonephritis and proteinuria who were treated with standard treatment and placebo
|
single dose of placebo that is similar to Empagliflozin in physical appearance
Other Names:
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
protein to creatinine ratio
Time Frame: 3 months
|
measurement of urinary protein to creatinine ratio as a marker of proteinuria
|
3 months
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
|---|---|---|
|
Decline of glomerular filtration rate
Time Frame: 3 months
|
Decline in estimated glomerular filtration rate over
|
3 months
|
Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Tarek Abdelaziz, PHD, Kasr Alainy Faculty of Medicine
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Actual)
Study Completion (Actual)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- KA-21-297
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
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