Ignite Creation Date:
2024-05-06 @ 6:41 PM
Last Modification Date:
2024-10-26 @ 2:52 PM
Study NCT ID:
NCT05748925
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2023-03-01
First Post:
2023-02-18
Brief Title:
Cardio Renal Effects of SGLT2 Inhibitors Among Lupus Nephritis Patients
Sponsor:
Mansoura University
Organization:
Mansoura University
Study Overview
Official Title:
Study of the Cardio Renal Effects of SGLT2 Inhibitors Among Diabetic and Non-diabetic Lupus Nephritis Patients
Status:
ACTIVE_NOT_RECRUITING
Status Verified Date:
2023-02
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
Brief Summary:
This study aims to assess sodium glucose linked transoprter inhibitorsSGT2i 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 mlmin173m2 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 placeboWe will follow up all patients for 12 months and compare their results
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 mlmin173m2 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 placeboWe 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 mlmin173m2 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 mlmin173m2 by cockcroft-gault equation 3 Exclusion criteria Patients with eGFR 30 mlmin per 173 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 inhibitorsACEI 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 mgkg 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 proteincreatinine 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 proteincreatinine 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
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 mlmin173m2 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 mlmin173m2 by cockcroft-gault equation 3 Exclusion criteria Patients with eGFR 30 mlmin per 173 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 inhibitorsACEI 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 mgkg 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 proteincreatinine 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 proteincreatinine 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
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
False
Is a FDA Regulated Device?:
False
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None