Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05748925

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
SLE Lupus Nephritis SGLT2 Inhibitors	Drug: dapagliflozin Drug: placebo	Phase 4

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.

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:

erythropoetin level
Hepcidin level.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

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.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.

Masking:

Double (Participant, Care Provider)

Masking Description:

double blind

Primary Purpose:

Prevention

Official Title:

Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients

Actual Study Start Date :

Oct 1, 2022

Anticipated Primary Completion Date :

Oct 1, 2023

Anticipated Study Completion Date :

Dec 1, 2023

Arms and Interventions

Arm	Intervention/Treatment
Active Comparator: 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	Drug: 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.
Active Comparator: control group Control group: will receive placebo as add on drug once daily with or without food for one year.	Drug: placebo Control group: will be maintained on their medication

Arm

Intervention/Treatment

Active Comparator: 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

Drug: 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.

Active Comparator: control group

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

Drug: placebo

Control group: will be maintained on their medication

Outcome Measures

Primary Outcome Measures

Effect of dapagliflozin compared to placebo on renal function [1 year]
Effect of dapagliflozin compared to placebo on eGFR.
Cardiovascular assessment in two groups [1 year]
effect of dapagliflozin compared to placebo on coronary calcification (NCCT model)
Effect of dapagliflozin compared to placebo on Erythropoietin level [1 year]
Erythropoietin level will be measured in two groups before and after intervention
Effect of dapagliflozin compared to placebo on hepcidin level [1 year]
hepcidin level will be measured in two groups before and after intervention

Secondary Outcome Measures

Effect of dapagliflozin compared to placebo on ECCHO parameters [1 year]
ECCHO will be done before and after intervention
Effect of dapagliflozin compared to placebo on body weight [1 year]
body weight will be assessed throughout the study

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Urology and Nephrology Center	Mansoura		Egypt	35511

Sponsors and Collaborators

Mansoura University

Investigators

None specified.

Study Documents (Full-Text)

None provided.

More Information

Publications

None provided.

Responsible Party:

Nourelsabah Mohamed, Nephrology specialist at mansoura urology and nephrology center, Mansoura University

ClinicalTrials.gov Identifier:

NCT05748925

Other Study ID Numbers:

MD.21.10.550

First Posted:

Mar 1, 2023

Last Update Posted:

Mar 1, 2023

Last Verified:

Feb 1, 2023

Individual Participant Data (IPD) Sharing Statement:

Yes

Plan to Share IPD:

Yes

Studies a U.S. FDA-regulated Drug Product:

Studies a U.S. FDA-regulated Device Product:

Additional relevant MeSH terms:

Nephritis

Lupus Nephritis

Dapagliflozin

Study Results

No Results Posted as of Mar 1, 2023