Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

NCT ID: NCT05748925

Last Updated: 2025-04-16

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 84 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2022-10-01
• Study Completion Date: 2024-01-01

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.

Detailed Description

Study sitting:

Nephrology and renal transplant unit at urology and nephrology center in Mansoura University.

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. The primary endpoint will be sustained decline in eGFR ≥50%, ESKD, or kidney or cardiovascular death We will follow up all patients for 12 months and compare their results.

2. Inclusion criteria: Patients aged more than 16 year. Willing to sign informed consent. Diagnosis of Systemic Lupus Erythematosus (SLE) according to american college of rheumatology (ACR) classification criteria.

Renal biopsy showed lupus nephritis. Patient with eGFR > 30 ml/min/1.73m2 by cockcroft-gault equation. 3. Exclusion criteria: 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 Angiotensin converting enzymes inhibitors(ACEI) and Angiotensin II receptor blockers (ARBS).

Patients who have frequent hypotensive episode or systolic blood pressure (SBP) <100 mmHg.

Operational design:

Study Protocol:

Patients included in the study will treated with dapaglifilozin initiated at a total daily dosage of 10 mg/kg per day.

Study design:

Type of the study: randomized controlled study.

The following data will be gathered and evaluated for all patients:

I-before intervention:

Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. Hemoglobin (HGB). Uric acid and lipid profile. Lupus serology.

II-after intervention: All patients will be evaluated monthly regarding:

Serum creatinine, creatinine clearance. 24 hour proteinuria, protein/creatinine ratio. Fasting, random and postprandial glucose levels. calcineurin inhibitors (CNI) trough level if used. Urine analysis. HGB level. Uric acid, lipid profile. Lupus serology.

Cardiovascular assessment:

Echocardiogram. Atherosclerosis and vascular calcification incidence (NCCT model). Regular measurement of blood pressure each visit

ll patients will be evaluated at 12 month regarding:

1. erythropoetin level

2. Hepcidin level.

Conditions

SLE; Lupus Nephritis; SGLT2 Inhibitors

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: PREVENTION
• Blinding Strategy: DOUBLE

Study Groups

study group

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

Group Type: ACTIVE_COMPARATOR

dapagliflozin

Intervention Type: 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.

control group

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

Group Type: ACTIVE_COMPARATOR

placebo

Intervention Type: DRUG

Control group: will be maintained on their medication

Interventions

dapagliflozin

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.

Intervention Type: DRUG

placebo

Control group: will be maintained on their medication

Intervention Type: DRUG

Eligibility Criteria

Inclusion Criteria

• 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.

Exclusion Criteria

• 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.

• Minimum Eligible Age: 16 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Mansoura University

OTHER

Sponsor Role: lead

Responsible Party

Nourelsabah Mohamed

Nephrology specialist at mansoura urology and nephrology center

Responsibility Role: PRINCIPAL_INVESTIGATOR

Locations

Urology and Nephrology Center

Al Mansurah, , Egypt

Countries

Egypt

Provided Documents

Document Type: Study Protocol

View Document

Document Type: Statistical Analysis Plan

View Document

Other Identifiers

MD.21.10.550

Identifier Type: -

Identifier Source: org_study_id