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

NCT05735197 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 100

Last updated 2024-11-08

No results posted yet for this study

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.

Conditions

  • Chronic Kidney Diseases
  • Bone Diseases, Metabolic

Interventions

DRUG

Dapagliflozin 10mg Tab

Dapagliflozin which is (SGLT2 inhibitor) will be used as add on medication.

DRUG

Placebo

Placebo which has the same shape as Dapagliflozin but without active ingredient will be used as add on medication for control group.

Sponsors & Collaborators

  • Mansoura University

    lead OTHER

Principal Investigators

  • Mohamed Mohsen elshayeb, Msc · Mansoura Urology and nephrology center, Mansoura University

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-09-01
Primary Completion
2023-08-10
Completion
2023-11-01

Countries

  • Egypt

Study Locations

More Related Trials

Entities

Drugs

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT05735197 on ClinicalTrials.gov