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NCT05735197
Effect of Dapagliflozin on Renal Outcomes and Bone Mineral Disease in Non-diabetic Chronic Kidney Disease Patients
Phase 4 trial testing Dapagliflozin 10mg Tab in Chronic Kidney Diseases in 100 participants. Completed in 1 November 2023.
10 August 2023
Quick facts
| Lead sponsor | Mansoura University |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | randomized |
| Design | parallel |
| Masking | single |
| Primary purpose | prevention |
| Enrollment | 100 |
| Start date | 1 September 2022 |
| Primary completion | 10 August 2023 |
| Estimated completion | 1 November 2023 |
| Sites | 1 location across Egypt |
Drugs / interventions tested
- Dapagliflozin 10mg Tab — full drug profile →
- Placebo
Conditions studied
- Chronic Kidney Diseases — all drugs for Chronic Kidney Diseases →
- Bone Diseases, Metabolic — all drugs for Bone Diseases, Metabolic →
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):
-
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 -
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:
- PubMed search for NCT05735197
- Europe PMC full search
- ASCO Meeting Library
- ESMO Meeting Library
- bioRxiv preprints
- medRxiv preprints
- Google Scholar
Related trials
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Trials testing the same drug.
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- NCT06427226 — Evaluation of the Possible Safety and Efficacy of Dapagliflozin in the Prophylaxis of Doxorubicin-Induced Cardiotoxicity · Phase 2 · recruiting
- NCT06373523 — MASLD in Primary Hypothyroidism and Efficacy of Dapaglifozin · EARLY_PHASE1 · not yet recruiting
- NCT06434025 — IV Iron and SGLT2 Inhibitor on Ventricular Function and Myocardial Iron Content in Heart Failure With Iron Deficiency · Phase 3 · not yet recruiting
Other recruiting trials for Chronic Kidney Diseases
Currently open trials in the same condition.
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- NCT06463483 — Automated Insulin Delivery in Adults With Advanced Kidney Disease · NA · recruiting
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Other Mansoura University trials
Trials by the same sponsor.
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- NCT07534943 — Effectiveness of Oleanolic Acid as Intracanal Medicament on Infectious/Inflammatory Contents in Teeth With Apical Period · NA · active not recruiting
Verify against primary sources
- ClinicalTrials.gov — authoritative US registry record
- WHO ICTRP — international registry index
- EU Clinical Trials Register
- Sponsor press releases (Google)
- Trial protocol + status: ClinicalTrials.gov NCT05735197 (US National Library of Medicine, public domain)
- Publications: Europe PMC API search by NCT ID, retrieved 10 June 2026
- Drug + disease cross-links: matched in real time against Drug Landscape's normalised drug + company + condition tables
- Sponsor: as reported to ClinicalTrials.gov by Mansoura University
- Last refreshed: 8 November 2024
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