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Active Not Recruiting NCT05735197

Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients

Conditions: Chronic Kidney Diseases, Bone Diseases, Metabolic

Sex: All
Ages: 18 Years – N/A
Phase: PHASE4
Enrollment: 100
Sponsor: Mansoura University

Location: Egypt

Summary

It is a randomized controlled trial in which 100 non diabetic chronic kidney disease (CKD) patient is being participated.Their estimated glomerular filtration rate (eGFR) between 25-75 ml/min/1.73 m2.Participants will be randomized into two groups:Study group: includes 50 patients, they will receive Sodium glucose co-transporter 2 inhibitor (SGLT2i) as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.Control group: includes 50 patients, they will receive placebo their medication.The investigators will follow up all patients for 12 months and compare their results.This study aims to:Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.

Eligibility Criteria

Inclusion Criteria:Patients aged more than 18 year.CKD patient with eGFR from 25 to 75 ml/min/1.73m2 with no evidence of acute drop of the GFR in the last 3 months.Willing to sign informed consent.Exclusion Criteria:eGFR less than 25 ml/min per 1.73 m2.Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.Inability to sign the study consent form or refusal to participate in the study.Evidence of urinary obstruction.Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS)..Patients with current history of frequent hypotensive episodes or systolic blood pressure <100 mmHg.Patients with history of recurrent urinary tract infection and/or valvovaginitisPatients with ongoing active malignancy.Patients with any evidence of active infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and tuberculosis (TB).Current or previous organ transplantation, or expected to get a kidney transplant within 12 months.Patients who received any SGLT2i for more than 3 months in the past.Patients who are already on medications that may affect or interact with bone metabolism such as bisphosphonates, calcitonin, steroid, denosumab and estrogen during the last 6 months.Pregnant and/or lactating woman.

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View on ClinicalTrials.gov

Source: ClinicalTrials.gov (NCT05735197). StuddyBuddy aggregates publicly available trial information.