A clinical trial to determine if the test drug (Dapagliflozin) is better that placebo (Dummy drug) when used along with the standard therapy in patients with chronic kidney disease in reducing incidence of worsening of this condition.

Phase 3

• Conditions: 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.

• Registration Number: CTRI/2017/08/009535
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Closed to Recruitment of Participants
• Sex: Not specified
• Target Recruitment: 0

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 <=75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

4. UACR >=200 and <=5000 mg/g at visit 1

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

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

Study & Design

• Study Type: Interventional
• Study Design: Not specified