Last reviewed · How we verify

NCT05735197

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

Completed Phase 4 Last updated 8 November 2024
What this trial tests

Phase 4 trial testing Dapagliflozin 10mg Tab in Chronic Kidney Diseases in 100 participants. Completed in 1 November 2023.

Timeline
1 September 2022
Primary endpoint
10 August 2023
1 November 2023

Quick facts

Lead sponsorMansoura University
PhasePhase 4
StatusCompleted
Study typeINTERVENTIONAL
Allocationrandomized
Designparallel
Maskingsingle
Primary purposeprevention
Enrollment100
Start date1 September 2022
Primary completion10 August 2023
Estimated completion1 November 2023
Sites1 location across Egypt

Drugs / interventions tested

Conditions studied

Sponsor

Mansoura University

Who can join

18 and older, any sex, with Chronic Kidney Diseases or Bone Diseases, Metabolic. Patients with the condition only — healthy volunteers not accepted.

Sponsor's own description

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.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

  1. New and Emerging Nonimmunosuppressive Drug Therapies for Primary Adult Glomerular Diseases.
    Mushailov V, Radhakrishnan J. · · 2025 · PMID 42165056 · DOI 10.1016/j.xkme.2025.101133
  2. Impact of dapagliflozin on bone mineral metabolism in non-diabetic patients with chronic kidney disease: a randomized, double-blind, placebo-controlled study.
    Elshayeb M, Abdulgalil A, El-Husseini A, Elhadedy M, et al · · 2026 · PMID 41800320 · DOI 10.1093/ckj/sfaf384

Verify or expand the search:

Other trials of Dapagliflozin 10mg Tab

Trials testing the same drug.

Other recruiting trials for Chronic Kidney Diseases

Currently open trials in the same condition.

Other Mansoura University trials

Trials by the same sponsor.

Verify against primary sources

Data sources for this page

Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT05735197.

Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing