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Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

Primary Purpose

SLE, Lupus Nephritis, SGLT2 Inhibitors

Status
Active
Phase
Phase 4
Locations
Egypt
Study Type
Interventional
Intervention
dapagliflozin
placebo
Sponsored by
Mansoura University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional prevention trial for SLE

Eligibility Criteria

16 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept 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.

Sites / Locations

  • Urology and Nephrology Center

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Active Comparator

Arm Label

study group

control group

Arm Description

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

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

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

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

Full Information

First Posted
February 18, 2023
Last Updated
February 18, 2023
Sponsor
Mansoura University
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1. Study Identification

Unique Protocol Identification Number
NCT05748925
Brief Title
Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients
Official Title
Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Active, not recruiting
Study Start Date
October 1, 2022 (Actual)
Primary Completion Date
October 1, 2023 (Anticipated)
Study Completion Date
December 1, 2023 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Mansoura University

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No

5. 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.
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: erythropoetin level Hepcidin level.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
SLE, Lupus Nephritis, SGLT2 Inhibitors

7. Study Design

Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Parallel Assignment
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.
Masking
ParticipantCare Provider
Masking Description
double blind
Allocation
Randomized
Enrollment
100 (Actual)

8. Arms, Groups, and Interventions

Arm Title
study group
Arm Type
Active Comparator
Arm Description
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
Arm Title
control group
Arm Type
Active Comparator
Arm Description
Control group: will receive placebo as add on drug once daily with or without food for one year.
Intervention Type
Drug
Intervention Name(s)
dapagliflozin
Intervention Description
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
Intervention Name(s)
placebo
Intervention Description
Control group: will be maintained on their medication
Primary Outcome Measure Information:
Title
Effect of dapagliflozin compared to placebo on renal function
Description
Effect of dapagliflozin compared to placebo on eGFR.
Time Frame
1 year
Title
Cardiovascular assessment in two groups
Description
effect of dapagliflozin compared to placebo on coronary calcification (NCCT model)
Time Frame
1 year
Title
Effect of dapagliflozin compared to placebo on Erythropoietin level
Description
Erythropoietin level will be measured in two groups before and after intervention
Time Frame
1 year
Title
Effect of dapagliflozin compared to placebo on hepcidin level
Description
hepcidin level will be measured in two groups before and after intervention
Time Frame
1 year
Secondary Outcome Measure Information:
Title
Effect of dapagliflozin compared to placebo on ECCHO parameters
Description
ECCHO will be done before and after intervention
Time Frame
1 year
Title
Effect of dapagliflozin compared to placebo on body weight
Description
body weight will be assessed throughout the study
Time Frame
1 year

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Accepts Healthy Volunteers
No
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.
Facility Information:
Facility Name
Urology and Nephrology Center
City
Mansoura
ZIP/Postal Code
35511
Country
Egypt

12. IPD Sharing Statement

Plan to Share IPD
Yes
IPD Sharing Plan Description
all individual participant data (IPD) that underlie results in a publication
IPD Sharing Time Frame
1 year

Learn more about this trial

Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients

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