Status:
COMPLETED
Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease
Lead Sponsor:
Kaohsiung Medical University
Conditions:
Chronic Kidney Diseases
Eligibility:
All Genders
20+ years
Phase:
PHASE3
Brief 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 fil...
Detailed Description
eGFR 30 mL/min/1.73m2 is a clinical cut point, below which advanced chronic kidney disease (CKD) (stage 4 and 5) is associated with a significantly increased risk of mortality and a 50-fold increased ...
Eligibility Criteria
Inclusion
- Provision of informed consent prior to any study specific procedures.
- Aged ≥20 years at the time of consent.
- eGFR ≥10 and ≤30 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation ) at randomization.
- eGFR decline ≥2.5 mL/min/1.73m2 (≥ 3 measurements, simple linear regression) in one year before randomization.
- In the pre-ESRD care and education program of Ministry of Health and Welfare of Taiwan (pre-ESRD program) for ≥3 months before randomization.
Exclusion
- Lupus nephritis, anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis and organ transplantation.
- Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.
- Any condition outside the renal and CV disease area, with a life expectancy of less than 2 years based on investigator's clinical judgement.
- Active malignancy requiring treatment at the time of visit 1.
- Women of child-bearing potential who are not willing to use a medically accepted method of contraception throughout the study, OR women who have a positive pregnancy test at enrolment OR women who are breast-feeding.
- Urinary tract obstruction (hydronephrosis, hydroureter and abnormal post-voiding residual urine volume under renal echography).
- Frequent urosepsis (≥2 times in one year before enrollment) and history of Fournier's gangrene.
- Inability of the patient, in the opinion of the investigator, to understand and/or comply with treatment, procedures and/or follow-up OR any conditions that, in the opinion of the investigator, may render the patient unable to complete the study.
Key Trial Info
Start Date :
May 27 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 31 2024
Estimated Enrollment :
180 Patients enrolled
Trial Details
Trial ID
NCT05196347
Start Date
May 27 2022
End Date
August 31 2024
Last Update
March 13 2025
Active Locations (1)
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1
Chi-Chih Hung
Kaohsiung City, Taiwan