Health Condition 1: N182- Chronic kidney disease, stage 2 (mild) Health Condition 2: null- Men and women â?¥18 years of age with Chronic Kidney Disease.
Conditions
Interventions
Intervention1: Dapagliflozin: Dapagliflozin Tablets
Control Intervention1: Placebo: Matching placebo for Dapagliflozin
Sponsors
AstraZeneca AB
Eligibility
Inclusion criteria
Inclusion criteria: 1. Provision of signed informed consent prior to any study specific procedures 2. Female or male aged >=18 years at the time of consent 3. eGFR >=25 and 4. UACR >=200 and 5. Stable, and for the patient maximum tolerated labelled daily dose, treatment with ACE-I or ARB for at least 4 weeks before visit 1, if not medically contraindicated
Exclusion criteria
Exclusion criteria: 1. Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis 2. Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment 3. History of organ transplantation 4. Receiving therapy with an SGLT2 inhibitor within 8 weeks prior to enrolment or previous intolerance of an SGLT2 inhibitor 5. Type 1 diabetes mellitus (T1D) 6. New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment (see Appendix C) 7. MI, unstable angina, stroke or transient ischemic attack (TIA) within 12 weeks prior to enrolment 8. Coronary revascularization (percutaneous coronary intervention [PCI] or coronary artery bypass grafting [CABG]) or valvular repair/replacement within 12 weeks prior to enrolment or is planned to undergo any of these procedures after randomization 9. Any condition outside the renal and CV disease area, such as but not limited to malignancy, with a life expectancy of less than 2 years based on investigator´s clinical judgement 10. Active malignancy requiring treatment at the time of visit 1 (with the exception of successfully treated basal cell or treated squamous cell carcinoma). 11. Hepatic impairment (aspartate transaminase [AST] or alanine transaminase [ALT] >3x the upper limit of normal [ULN]; or total bilirubin >2x ULN at time of enrolment) 12. Known blood borne diseases such as specified in Appendix B (category A and B) 13. Women of child-bearing potential (ie, those who are not chemically or surgically sterilised or who are not post-menopausal) who are not willing to use a medically accepted method of contraception that is considered reliable in the judgment of the investigator OR women who have a positive pregnancy test at enrolment or randomization OR women who are breast-feeding
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To determine if dapagliflozin is superior to placebo in reducing the incidence of the primary composite endpoint of more than 50% sustained decline in estimated glomerular filtration rate (eGFR), reaching end stage renal disease (ESRD), CV or renal death when added to current background therapy in patients with eGFR less than 25 and less than 75 ml/min/1.73m2 and albuminuria (urine albumin creatinine ratio [UACR] more than 200 and less than 5000 mg/g).Timepoint: 1. 50% sustained decline in eGFR 2. Reaching ESRD a. Sustained eGFR less than15 mL/min/1.73m2 or, b. Chronic dialysis treatment or, c. Receiving a renal transplant 3. CV death 4. Renal death | — |
Secondary
| Measure | Time frame |
|---|---|
| To determine whether dapagliflozin compared with placebo will result in a reduction of the incidence of the composite endpoints of worsening of renal function.Timepoint: 1. more than 50% sustained decline in eGFR 2. Reaching ESRD 3. Renal death 4. CV death 5. Hospitalization for heart failure | — |
Countries
Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Mexico, Peru, Philippines, Poland, Republic of Korea, Romania, Russian Federation, Spain, Sweden, Ukraine, United Kingdom, United States of America, Viet Nam
Contacts
Public ContactMr Tapankumar M Shah
AstraZeneca Pharma India Limited
Outcome results
None listed