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

• Status: Active, not recruiting
• Trial end date: 2024-01-10
• Target enrollment: 0
• Participant gender: All

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:

1. Assess SGLT2i role in delaying the progression of ongoing chronic kidney disease.

2. Study the impact of SGLT2i on bone and mineral metabolism in this patients' population.

• Phase: Phase 4
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Mansoura University
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Patients aged more than 18 year.

2. 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.

3. Willing to sign informed consent.

Exclusion Criteria:

1. eGFR less than 25 ml/min per 1.73 m2.

2. Medical history of chronic disease (diabetes mellitus, chronic liver and/or respiratory diseases).

3. Patients with primary or secondary glomerulonephritis/ nephrotic syndrome (proteinuria ≥ 3.5 gm/day) and/or any evidence of active immunological/ collagen vascular disease.

4. Inability to sign the study consent form or refusal to participate in the study.

5. Evidence of urinary obstruction.

6. Patients with evidence of volume depletion or receiving a combination of angiotensin converting enzyme (ACE) inhibitors and angiotensin receptor blockers (ARBS)..

7. Patients with current history of frequent hypotensive episodes or systolic blood pressure <100 mmHg.

8. Patients with history of recurrent urinary tract infection and/or valvovaginitis

9. Patients with ongoing active malignancy.

10. Patients with any evidence of active infection including human immunodeficiency virus (HIV), hepatitis B virus (HBV), hepatitis C virus (HCV) and tuberculosis (TB).

11. Current or previous organ transplantation, or expected to get a kidney transplant within 12 months.

12. Patients who received any SGLT2i for more than 3 months in the past.

13. 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.

14. Pregnant and/or lactating woman.