NCT01756703

A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria

A Randomised, Double-blind, Placebo-controlled Study to Evaluate the Effect on Urine Albumin-to-Creatinine Ratio (UACR), Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of Multiple Oral Doses of MT-3995 as Add-on Therapy to ACE-I or ARB in Type II Diabetic Nephropathy Subjects With Albuminuria and an eGFR ≥60 mL/Min/1.73m^2

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 67 (actual)
• Sponsor: Tanabe Pharma Corporation · Industry
• Sex: All
• Age: 18 Years – 75 Years
• Healthy volunteers: Not accepted

Summary

The purpose of this study is to evaluate pharmacodynamics, safety, tolerability and pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects with Albuminuria

Conditions

• Diabetic Nephropathy

Interventions

Type	Name	Description
DRUG	MT-3995 Low	MT-3995 Low dose for 8 weeks
DRUG	MT-3995 High	MT-3995 High dose for 8 weeks
DRUG	Placebo	Placebo for 8 weeks

Timeline

• Start date: 2012-11-01
• Primary completion: 2014-08-01
• Completion: 2014-08-01
• First posted: 2012-12-27
• Last updated: 2015-02-09

Locations

43 sites across 5 countries: Bulgaria, Hungary, Lithuania, Romania, Slovakia