Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease (NCT05196347) | Clinical Trial Compass
CompletedPhase 3
Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease
Taiwan180 participantsStarted 2022-05-27
Plain-language 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.
Who can participate
Age range20 Years
SexALL
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Inclusion criteria
✓. 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 criteria
✕. 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.
✕
What they're measuring
1
eGFR slope
Timeframe: from randomization to renal replacement therap, study completion or censoring event, upto 96 weeks
. 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.