Clinical Trial: A Study in CKD Patients With Type 2 Diabetes Mellitus and Albuminuria
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: An Exploratory Phase 2, Randomized, Double-blind, Placebo-controlled, Parallel Design Study to Evaluate the Safety, Tolerability, and Pharmacodynamics of AZD1722 in CKD Patients With Type 2 Diabetes M
Brief Summary: The purpose of this study is to determine if the study drug is safe, tolerable and active in reducing albuminuria in patients with Chronic Kidney Disease with Type 2 Diabetes.
Detailed Summary:
Sponsor: Ardelyx
Current Primary Outcome: Changes in Urine Albumin to Creatinine Ratio (UACR) [ Time Frame: Baseline to Week 12 ]
Original Primary Outcome: Same as current
Current Secondary Outcome: PD effect on UACR, eGFR, blood pressure, p-NT-proBNP, s-cardiac troponin, u-aldosterone, p-renin activity, and bioimpedance [ Time Frame: Baseline to Week 12 ]
Original Secondary Outcome: Same as current
Information By: Ardelyx
Dates:
Date Received: May 2, 2013
Date Started: May 2013
Date Completion:
Last Updated: September 18, 2015
Last Verified: September 2015