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

Sponsor
Mansoura University
Study ID
NCT05735197
Phase
PHASE4
Status
Completed

Conditions

  • Bone Diseases, Metabolic
  • Chronic Kidney Diseases

Eligibility Criteria

Sex
ALL
Age
18 Years - N/A
Healthy Volunteers
Not accepted

Interventions

  • Dapagliflozin 10mg Tab — DRUG
    Dapagliflozin which is (SGLT2 inhibitor) will be used as add on medication.
  • Placebo — DRUG
    Placebo which has the same shape as Dapagliflozin but without active ingredient will be used as add on medication for control group.

Study Details

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.

Key Dates

Start date
Sep 1, 2022
Status verified
Nov 2024
Primary completion
Aug 10, 2023
Completion
Nov 1, 2023

Study Design

Enrollment
100 participants (actual)
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
PREVENTION

Arms

  • Active Comparator: Dapagliflozin group
    Includes 50 patients, they will receive SGLT2i as add on drug, Dapagliflozin 10 mg will be used once daily with or without food.
  • Placebo Comparator: Placebo group
    Includes 50 patients, they will receive placebo plus their medication.

Primary Outcome Measure

Effect of dapagliflozin on CKD progression [ Time Frame: 1 year ]

Related Studies