A study to evaluate if dapagliflozin can prevent the gradual loss of kidney function and improve survival for patients with chronic kidney disease.

Phase 1

• Conditions: Chronic kidney disease (CKD); MedDRA version: 21.1Level: PTClassification code 10064848Term: Chronic kidney diseaseSystem Organ Class: 10038359 - Renal and urinary disorders; Therapeutic area: Diseases [C] - Cardiovascular Diseases [C14]

• Registration Number: EUCTR2016-003896-24-DK
• Lead Sponsor: AstraZeneca AB

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2016-12-19
• Last Update Posted: 13 July 2020

Recruitment & Eligibility

• Status: ot Recruiting
• Sex: All
• Target Recruitment: 4000

Inclusion Criteria

• Provision of signed informed consent prior to any study specific procedures

• Female or male aged =18 years at the time of consent

• eGFR =25 and =75 mL/min/1.73m2 (CKD-EPI Formula) at visit 1

• Evidence of increased albuminuria 3 months or more before visit 1 and UACR =200 and =5000 mg/g at visit 1

• 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
Are the trial subjects under 18? no
Number of subjects for this age range:
F.1.2 Adults (18-64 years) yes
F.1.2.1 Number of subjects for this age range 2000
F.1.3 Elderly (>=65 years) yes
F.1.3.1 Number of subjects for this age range 2000

Exclusion Criteria

• Autosomal dominant or autosomal recessive polycystic kidney disease, lupus nephritis or ANCA-associated vasculitis

• Receiving cytotoxic therapy, immunosuppressive therapy or other immunotherapy for primary or secondary renal disease within 6 months prior to enrolment

• History of organ transplantation

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

• Type 1 diabetes mellitus

• New York Heart Association (NYHA) class IV Congestive Heart Failure at the time of enrolment

• MI, unstable angina, stroke or transient ischemic attack within 12 weeks prior to enrolment

Study & Design

• Study Type: Interventional clinical trial of medicinal product
• Study Design: Not specified