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Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease

NCT05196347 · Status: COMPLETED · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 180

Last updated 2025-03-13

No results posted yet for this study

Summary

This is an investigator-led, randomized, open-label, blinded-endpoint, multicenter study that will include a total of approximately 180 subjects from 2 sites. Subjects with an estimated glomerular filtration rate (eGFR) of 10 to 30 mL/min/1.73m2 will be included. The goal of this study is to assess the efficacy and safety of dapagliflozin (Forxiga®, AstraZeneca) in reducing renal function progression and complications of chronic kidney disease (CKD) in patients with CKD stage 4 and 5 under the integrated CKD care. Subjects will be allocated to integrated CKD care program + dapagliflozin or integrated CKD care program alone. The primary endpoint is eGFR decline after randomization between 2 arms. The secondary endpoints are renal and cardiovascular composite outcomes.

Conditions

  • Chronic Kidney Diseases

Interventions

DRUG

Dapagliflozin

In dapagliflozin arm, subjects will be received dapagliflozin 5 mg for 4 weeks. Uptitration to 10 mg will be done between 5 to 12th weeks, if eGFR dip \<20%.

Sponsors & Collaborators

  • Kaohsiung Medical University

    lead OTHER

Principal Investigators

  • Chi-Chih Hung, MD · Kaohsiung Medical University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
20 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2022-05-27
Primary Completion
2024-08-31
Completion
2024-08-31
FDA Drug
Yes

Countries

  • Taiwan

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 NCT05196347 on ClinicalTrials.gov