NCT05704088CompletedPhase 4
SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Lupus Nephritis Patients
SGLT2 Inhibitors Between Reno Protective Effects and Impact on Bone and Mineral Disease Among Diabetic and Non- Diabetic Lupus Nephritis Patients
Source: ClinicalTrials.gov · Last updated 15 Oct 2024
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 100 (actual)
- First submitted
- 10 Jan 2023
- Start date
- 8 Oct 2022
- Primary completion date
- 8 Jan 2024
- Lead sponsor
- Mansoura University
- Diseases
- Lupus (SLE)
- NCT number
- NCT05704088
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 100
- From 8 Oct 2022 to the primary completion date, 8 Jan 2024
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- Who are receiving high dose diuretics or combined angiotensin-converting enzyme inhibitor (ACEI) and Angiotensin II receptor blockers (ARBS).
- 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
Other illness
- With medical history of chronic disease (chronic liver disease, cancer, severe respiratory distress, gastrointestinal tract lesions).
- Who have frequent hypotensive episode or systolic blood pressure \<100 mmHg. Active malignancy.
- Active infection including HIV.
Lab values
- With eGFR \<30 ml/min per 1.73 m2.
Other
- Who is currently pregnancy or lactation.
- Refuse to participate in the study or lost follow up.
- With evidence of urinary obstruction of difficulty in voiding at screening.
Who the study is looking for
- 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.
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Urology and Nephrology Center Coordinator of this site? Confirm its status | Al Mansurah | Egypt | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.