Clinical Trial: Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Study Status: Completed
Recruit Status: Completed
Study Type: Interventional
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Evaluate Efficacy and Safety of MT-3995 in Patients With Diabetic Nephropathy
Brief Summary: The purpose of this study is to evaluate the efficacy of MT-3995 in subjects with diabetic nephropathy, compared with placebo, using urine albumin- to-creatinine ratio (UACR) in the first morning void urine sample as an indicator.
Detailed Summary:
Sponsor: Mitsubishi Tanabe Pharma Corporation
Current Primary Outcome: Change form baseline in UACR [ Time Frame: Week 24 ]
Original Primary Outcome: Same as current
Current Secondary Outcome:
- Change in UACR classification [ Time Frame: From baseline to 24 weeks ]
- Change in renal function [ Time Frame: From baseline to 24 weeks ]
- Change in serum potassium [ Time Frame: From baseline to 24 weeks ]
- Adverse events [ Time Frame: From baseline to 24 weeks ]
Original Secondary Outcome: Same as current
Information By: Mitsubishi Tanabe Pharma Corporation
Dates:
Date Received: August 4, 2015
Date Started: July 2015
Date Completion:
Last Updated: March 1, 2017
Last Verified: March 2017
