SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients

Sponsor

Mansoura University (Other)

Overall Status

Active, not recruiting

CT.gov ID

NCT05704088

Collaborator

(none)

100

Enrollment

Location

Arms

Anticipated Duration (Months)

7.1

Patients Per Site Per Month

Study Details

Study Description

Brief Summary

The goal of this Randomized, controlled trial in 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.

The main questions it aims to answer are:

Assess the role of sodium glucose co transporter 2 inhibitors (SGLT2i) in regression of ongoing kidney and cardiac diseases among diabetic or non-diabetic patients with lupus nephritis (LN) under different immunosuppressive therapies.
Investigate the impact of SGLT2i on bone and mineral metabolism in these patients.

Participants 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: will be maintained on their medication.

Condition or Disease	Intervention/Treatment	Phase
SGLT2 INHIBITORS Lupus Nephritis BMD	Drug: Dapagliflozin tablet Drug: placebo	Phase 4

Detailed Description

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

Study design and sample size:

Randomized, controlled trial that will include 100 patients with Lupus nephritis (LN) with an estimated glomerular filtration rate of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center.

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: will be maintained on their medication.

Study Protocol:

Patients in the study group will treated with dapagliflozin initiated at a total daily dosage of 10 mg once daily.

Methods:

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

I-before intervention:

Patients of both groups will be subjected to full history taking including duration of LN and drug history and routine clinical examination including blood pressure and BMI measurements.

Laboratory investigations:

Serum creatinine, Creatinine clearance. 24 hour urine protein, urine protein/creatinine ratio. Urine analysis. HBA1c. hemoglobin (HGB). Uric acid and lipid profile. Lupus serology. immunoreactive parathyroid hormone (iPTH). Vitamin D level. Fibroblast growth factor 23 level. bone turnover markers : bone specific alkaline phosphates propeptides of type 1 procollagen tartrate resistant acid phosphatase 5b sclerostin level

Radiological investigation:

Quantitative computed tomography: to detect bone and mineral density (BMD). Cardiovascular assessment: Echocardiography and vascular calcification incidence (NCCT model) : for detection of coronary calcification.

II-after intervention:

All patients will be evaluated monthly regarding:

Regular measurement of blood pressure each visit.

Laboratory investigations:

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.

All patients will be evaluated every 3 month regarding:

iPTH
Vitamin D level

All patients will be evaluated at 12 month regarding:

Fibroblast growth factor 23 level
High resolution quantitative computed tomography.
Bone turnover markers.

Study Design

Study Type:

Interventional

Actual Enrollment :

100 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Intervention Model Description:

Randomized, controlled trial that will include 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. 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: will be maintained on their medication.Randomized, controlled trial that will include 100 patients with LN with an estimated glomerular filtration rate (eGFR) of 25-75 ml/min/1.73m2. Diagnosis of LN was performed by renal biopsy, and all of the renal biopsies were carried out at urology and nephrology center. 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: will be maintained on their medication.

Masking:

Triple (Participant, Care Provider, Investigator)

Primary Purpose:

Prevention

Official Title:

SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients

Actual Study Start Date :

Oct 8, 2022

Anticipated Primary Completion Date :

Oct 8, 2023

Anticipated Study Completion Date :

Dec 8, 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 year.	Drug: Dapagliflozin tablet randomized control trial, study group will receive dapagliflozin tablets
Placebo Comparator: control group Control group: will receive placebo as add on drug once daily with or without food for one year.	Drug: placebo randomized control trial, control group will receive placebo tablets

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 year.

Drug: Dapagliflozin tablet

randomized control trial, study group will receive dapagliflozin tablets

Placebo Comparator: control group

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

Drug: placebo

randomized control trial, control group will receive placebo tablets

Outcome Measures

Primary Outcome Measures

effect of dapagliflozin on renal function [1 year]
Effect of dapagliflozin on eGFR (ml/ min).
effect of dapagliflozin on kidney function [1 year]
Effect of dapagliflozin on s.creatinine (mg/dl).
effect of dapagliflozin on BMD [1 year]
Effect of dapagliflozin on osteoporosis using Qct
effect of dapagliflozin on minerals [1 year]
Effect of dapagliflozin on serum calcium and phosphorus (mg/dl)
effect of dapagliflozin on Bone [1 year]
Effect of dapagliflozin on bone turnover markers (ng/dl)

Secondary Outcome Measures

effect of dapagliflozin on blood pressure [1 year]
measuring systolic and diastolic blood pressure mmgh before and after intervention
effect of dapagliflozin on body weight [1 year]
assessing body weight in kg before and after intervention

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years and Older

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

Inclusion Criteria:

Age of patient is more than 18.
Patients who are willing to sign informed consent.
Patients with SLE diagnosed according to EULAR/ACR classification criteria.
Patients with LN according to renal biopsy.
Patients with eGFR > 30 ml/min/1.73m2.

Exclusion Criteria:

With eGFR <30 ml/min per 1.73 m2.
Who is currently pregnancy or lactation.
With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).
Refuse to participate in the study or lost follow up.
With evidence of urinary obstruction of difficulty in voiding at screening.
Who are receiving high dose diuretics or combined angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin II receptor blockers (ARBS).
Who have frequent hypotensive episode or systolic blood pressure <100 mmHg. Active malignancy.
Active infection including HIV.
Any medications that may affect or interact with bone metabolism such as calcitonin, , denosumab, estrogen and fluoride during the last 6 months.
Current or previous organ transplantation, or expected to get a kidney transplant within 12 months

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:

Mohamed Hosny, nephrology specialist at urology and nephrology center (principle investigator), Mansoura University

ClinicalTrials.gov Identifier:

NCT05704088

Other Study ID Numbers:

MD.21.12.574

First Posted:

Jan 30, 2023

Last Update Posted:

Jan 30, 2023

Last Verified:

Jan 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:

Product Manufactured in and Exported from the U.S.:

Keywords provided by Mohamed Hosny, nephrology specialist at urology and nephrology center (principle investigator), Mansoura University

SGLT2 INHIBITORS

BMD

systemic lupus erythematosus

Additional relevant MeSH terms:

Nephritis

Lupus Nephritis

Dapagliflozin

Study Results

No Results Posted as of Jan 30, 2023