Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

NCT05748925 | Completed Phase 4 Results

• 1 other identifier: MD.21.10.550
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

This study aims to assess sodium glucose linked transoprter inhibitors(SGT2i) role in regression of ongoing kidney and cardiac diseases among lupus nephritis patient either diabetic or non-diabetic under different immunosuppressive therapy. The main objective of this study is to: To compare use of sodium glucose linked transoprter inhibitors (SGLT2i) versus standard care in regression of chronic kidney disease in patient with lupus nephritis (LN). To study the safety and efficacy of this drug group with use of immunosuppression and possible interaction. Patients with an estimated glomerular filtration rate (eGFR) \>30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.We will follow up all patients for 12 months and compare their results.

Conditions

SLE; Lupus Nephritis; SGLT2 Inhibitors

Outcome Measures

Primary Outcomes (6)

• Effect of Dapagliflozin Compared to Placebo on Renal Function After One Year

  Effect of dapagliflozin compared to placebo on eGFR,24- hour urinary protein

  one year

• Cardiovascular Assessment in Two Groups

  Coronary artery calcification will be measured using non-contrast computed tomography (NCCT). The Agatston score, a standardized method for quantifying coronary calcification, will be used to assess and compare baseline and 1-year follow-up measurements between the dapagliflozin and placebo groups.

  1 year

• Effect of Dapagliflozin Compared to Placebo on Erythropoietin Level

  Erythropoietin level will be measured in two groups before and after intervention

  1 year

• Effect of Dapagliflozin Compared to Placebo on Hepcidin Level

  hepcidin level will be measured in two groups before and after intervention

  1 year

• Effect of Dapagliflozin Compared to Placebo on Renal Function

  Effect of dapagliflozin compared to placebo on 24- hour urinary protein after 1 year

  1 year

• Effect of Dapagliflozin Compared to Placebo on Renal Function

  Effect of Dapagliflozin Compared to Placebo on Renal Function on uric acid after 1 year

  1 year

Secondary Outcomes (2)

• Effect of Dapagliflozin Compared to Placebo on ECCHO Parameters

  1 year

• Effect of Dapagliflozin Compared to Placebo on Body Weight

  1 year

Study Arms (2)

study group

ACTIVE COMPARATOR

study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food for one ye

Drug: dapagliflozin

control group

ACTIVE COMPARATOR

Control group: will receive placebo as add on drug once daily with or without food for one year.

Drug: placebo

Interventions

dapagliflozin DRUG

The patients will be randomized into two groups Study group: will receive SGLT2i as add on drug or replace another drug according to the patient clinical situation, Dapagliflozin 10 mg will be used once daily with or without food.

study group

placebo DRUG

Control group: will be maintained on their medication

control group

Eligibility Criteria

• Age: 16 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Patients aged more than 16 year.
• Willing to sign informed consent.
• Diagnosis of SLE according to EULAR/ACR classification criteria.
• Renal biopsy showed lupus nephritis.
• Patient with eGFR \> 30 ml/min/1.73m2 by cockcroft-gault equation.

You may not qualify if:

• Patients with eGFR \<30 ml/min per 1.73 m2.
• Current pregnancy or lactation.
• Medical history of chronic disease (CLD, cancer, severe respiratory distress, gastrointestinal tract lesions).
• Patients refusing to participate in the study or lost follow up.
• Evidence of urinary obstruction of difficulty in voiding at screening.
• Patients who are receiving high dose diuretics or combined ACEI, Angiotensin II receptor blockers (ARBS).
• Patients who have frequent hypotensive episode or SBP \<100 mmHg.

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Lupus Erythematosus, Systemic; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Results Point of Contact

• Title: Nourelsabah Mohamed Elbialy , consaltant nephrology
• Organization: mansoura urology and nephrology center

nourelsabah@mans.edu.eg

01065619243

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, CARE PROVIDER
• Masking Details: double blind
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Nephrology specialist at mansoura urology and nephrology center

Model Details: randomized controlled trial, It will include 100 patients with lupus nephritis, Diagnosis of glomerulonephritis was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. Patients with an estimated glomerular filtration rate (eGFR) \>30 ml/min/1.73m2 will be randomized into two groups Study group will receive SGLT2i inhibitor as add on drug or replace another drug according to patient clinical situation, Dapagliflozin 10 mg and 25 mg will be used once daily with or without food. Control group will be maintained on placebo.

Study Record Dates

• First Submitted: February 18, 2023
• First Posted: March 1, 2023
• Study Start: October 1, 2022
• Primary Completion: January 1, 2024
• Study Completion: January 1, 2024
• Last Updated: April 16, 2025
• Results First Posted: April 16, 2025

Record last verified: 2025-04

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: 1 year

Locations

EG (1)