A STUDY TO EVALUATE THE EFFECT OF DAPAGLIFLOZIN ON RENAL OUTCOMES AND CARDIOVASCULAR MORTALITY IN PATIENTS WITH CHRONIC KIDNEY DISEASE

Not Applicable

• Conditions: -N19 Unspecified kidney failure; Unspecified kidney failure; N19

• Registration Number: PER-055-16
• Lead Sponsor: ASTRAZENECA PERU S.A.,

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2017-05-17
• Study Completion: 2020-06-12
• Last Update Posted: 4 September 2023

Recruitment & Eligibility

• Status: Complete
• Sex: All
• Target Recruitment: 218

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

Exclusion criteria is shared in Section 3.2 of the protocol (pages 26-27) there are 17 exclusion criteria

Study & Design

• Study Type: Interventional
• Study Design: Not specified