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

NCT05704088 | Completed Phase 4

• 1 other identifier: MD.21.12.574
• Study Type: interventional
• Target: 100
• Locations: 1 country
• Sites: 1

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. 1\. 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.

Conditions

SGLT2 INHIBITORS; Lupus Nephritis; BMD

Keywords

SGLT2 INHIBITORS; BMD; systemic lupus erythematosus

Outcome Measures

Primary Outcomes (5)

• effect of dapagliflozin on renal function

  Effect of dapagliflozin on eGFR (ml/ min).

  1 year

• effect of dapagliflozin on kidney function

  Effect of dapagliflozin on s.creatinine (mg/dl).

  1 year

• effect of dapagliflozin on BMD

  Effect of dapagliflozin on osteoporosis using Qct

  1 year

• effect of dapagliflozin on minerals

  Effect of dapagliflozin on serum calcium and phosphorus (mg/dl)

  1 year

• effect of dapagliflozin on Bone

  Effect of dapagliflozin on bone turnover markers (ng/dl)

  1 year

Secondary Outcomes (2)

• effect of dapagliflozin on blood pressure

  1 year

• effect of dapagliflozin on body weight

  1 year

Study Arms (2)

study group

ACTIVE COMPARATOR

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

control group

PLACEBO COMPARATOR

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

Drug: placebo

Interventions

Dapagliflozin tablet DRUG

randomized control trial, study group will receive dapagliflozin tablets

study group

placebo DRUG

randomized control trial, control group will receive placebo tablets

control group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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

Sponsors & Collaborators

• Mansoura University: lead

Study Sites (1)

Urology and Nephrology Center

Al Mansurah, 35511, Egypt

Location

MeSH Terms

Conditions

Lupus Nephritis; Lupus Erythematosus, Systemic

Interventions

dapagliflozin

Condition Hierarchy (Ancestors)

Glomerulonephritis; Nephritis; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Connective Tissue Diseases; Skin and Connective Tissue Diseases; Autoimmune Diseases; Immune System Diseases

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: nephrology specialist at urology and nephrology center (principle investigator)

Model Details: 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.

Study Record Dates

• First Submitted: January 10, 2023
• First Posted: January 30, 2023
• Study Start: October 8, 2022
• Primary Completion: January 8, 2024
• Study Completion: January 8, 2024
• Last Updated: October 15, 2024

Record last verified: 2024-10

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, CSR

Locations

EG (1)