This trial is active, not recruiting.

Condition diabetic nephropathy
Treatments mt-3995 low, mt-3995 high, placebo
Phase phase 2
Sponsor Mitsubishi Tanabe Pharma Corporation
Start date November 2012
End date November 2014
Trial size 90 participants
Trial identifier NCT01756703, MT-3995-E06


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

United States No locations recruiting
Other countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
mt-3995 low
MT-3995 Low dose for 8 weeks
mt-3995 high
MT-3995 High dose for 8 weeks
(Placebo Comparator)
Placebo for 8 weeks

Primary Outcomes

Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
time frame: up to 8 weeks
Frequency and nature of treatment-emergent adverse events and serious adverse events.
time frame: up to 16 weeks

Secondary Outcomes

Percentage change from baseline in UACR compared to placebo
time frame: up to 8 weeks
Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
time frame: up to 8 weeks
Plasma concentrations of MT-3995 and its major metabolite
time frame: up to 16 weeks

Eligibility Criteria

Male or female participants from 18 years up to 75 years old.

Inclusion Criteria: - Subjects with Type II diabetic nephropathy, who have been treated with angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB) - Glycosylated haemoglobin (HbA1c) ≤10.5% - An estimated glomerular filtration rate (eGFR) ≥60 mL/min/1.73m^2 - Subject with albuminuria Exclusion Criteria: - History of Type I diabetes, pancreas or β-cell transplantation, or diabetes secondary to pancreatitis or pancreatectomy - Serum potassium level <3.5 or >5.0 mmol/L - Subjects who had acute kidney injury (AKI) within 3 months prior to baseline or have undergone renal dialysis at any time prior to randomisation - Subjects with a history of renal transplant - Subjects with clinically significant hypotension

Additional Information

Official title 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
Trial information was received from ClinicalTrials.gov and was last updated in September 2014.
Information provided to ClinicalTrials.gov by Mitsubishi Tanabe Pharma Corporation.