Dapagliflozin and Renal Surrogate Outcomes in Advanced Chronic Kidney Disease

• Status: Not yet recruiting
• Trial end date: 2023-09-30
• Target enrollment: 0
• Participant gender: All

Summary

This is an investigator-led, randomized, open-label, blinded-endpoint, multicenter study that will include a total of approximately 225 subjects from 3 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 end point is eGFR decline 12-52 weeks after randomization between 2 arms.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Kaohsiung Medical University
• Treatments: Dapagliflozin

Criteria

Inclusion Criteria:

1. Provision of informed consent prior to any study specific procedures.

2. Aged ≥20 years at the time of consent.

3. eGFR ≥10 and ≤30 mL/min/1.73m2 (Modification of Diet in Renal Disease (MDRD) equation ) at randomization.

4. eGFR decline ≥2.5 mL/min/1.73m2 (≥ 3 measurements, simple linear regression) in one year before randomization.

5. Urine albumin-to-creatinine ratio (UACR) 200-5000 mg/g or urine protein-to-creatinine ratio (UPCR) 300-7500 mg/g at least in one measurement in one year before randomization.

6. 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:

1. Lupus nephritis, anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis and organ transplantation.

2. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor.

3. Any condition outside the renal and CV disease area, with a life expectancy of less than 2 years based on investigator's clinical judgement.

4. Active malignancy requiring treatment at the time of visit 1.

5. 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.

6. Urinary tract obstruction (hydronephrosis, hydroureter and abnormal post-voiding residual urine volume under renal echography).

7. Frequent urosepsis (≥2 times in one year before enrollment) and history of Fournier's gangrene.

8. 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.