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

Status

Active, not recruiting

Phases

Unknown

Study type

Interventional

Source

REPEC

Registry ID

PER-055-16

Enrollment

200

Registered

2017-05-17

Start date

2017-03-15

Completion date

Unknown

Last updated

2023-09-04

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dapagliflozin 10 mg Green, plain, diamond shaped, film coated tablets 10 mg

Matching placebo for Dapagliflozin 10 mg Green, plain, diamond shaped, film coated tablets placebo

Dapagliflozin 5 mg Green, plain, diamond shaped, film coated tablets 5 mg

Matching placebo for Dapagliflozin 5 mg Green, plain, diamond shaped,film coated tablets placebo. At randomization, visit 2 (day 0), eligible patients will be randomly assigned to 1 of 2 treatm

Placebo – one placebo tablet to match dapagliflozin 10 mg, given once daily per oral use

Eligibility

Sex/Gender

All

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

Countries

Argentina, Brazil, Canada, China, Denmark, Germany, Hungary, India, Korea South, Mexico, Peru, Philippines, Poland, Russian Federation, Sweden, United Kindgdom, United States, Vietnam

Contacts

Public ContactUrsula Isabel Rodriguez-Frias

ASTRAZENECA PERU S.A.

Ursula.RodriguezFrias@astrazeneca.com6101515

Outcome results