Empagliflozin in Patients With Glomerulonephritis

NCT05283057 | Completed Phase 3

• 1 other identifier: KA-21-297
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

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.

Conditions

Glomerulonephritis; Proteinuria

Keywords

sodium glucose cotransporter inhibitors; Empagliflozin

Outcome Measures

Primary Outcomes (1)

• protein to creatinine ratio

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

  3 months

Secondary Outcomes (1)

• Decline of glomerular filtration rate

  3 months

Study Arms (2)

Group 1: Empagliflozin

ACTIVE COMPARATOR

25 patients with glomerulonephritis and proteinuria who were treated with Empagliflozin

Drug: Empagliflozin 25 MG

Group 2:

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Empagliflozin 25 MG DRUG

single dose of the SGLT inhibitor Empagliflozin was given

Also known as: EMPA

Group 1: Empagliflozin

placebo DRUG

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

Also known as: PLAC

Group 2:

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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
• m2 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.

Sponsors & Collaborators

• Kasr El Aini Hospital: lead

Study Sites (1)

Cairo university hospitals

Cairo, Egypt

Location

MeSH Terms

Conditions

Glomerulonephritis; Proteinuria

Interventions

empagliflozin; 5'-palmitoyl cytarabine

Condition Hierarchy (Ancestors)

Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Urination Disorders; Urological Manifestations; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Officials

• Tarek Abdelaziz, PHD

  Kasr Alainy faculty of medicine

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Study Record Dates

• First Submitted: March 7, 2022
• First Posted: March 16, 2022
• Study Start: February 20, 2020
• Primary Completion: September 30, 2021
• Study Completion: September 30, 2021
• Last Updated: March 16, 2022

Record last verified: 2022-03

Locations

EG (1)