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Completed

NCT Number: NCT01756703

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

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

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Key information

Conditions

Diabetic Nephropathy Diabetes Complications Diabetes Mellitus Diabetic Nephropathies Endocrine System Diseases Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Urogenital Diseases Urologic Diseases

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Investigational site, Blagoevgrad, Bulgaria

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Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

MT-3995 Low

Drug

MT-3995 Low dose for 8 weeks

MT-3995 High

Drug

MT-3995 High dose for 8 weeks

Placebo

Drug

Placebo for 8 weeks

Primary outcomes

  1. Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.

    Time frame: up to 8 weeks

  2. Frequency and nature of treatment-emergent adverse events and serious adverse events.

    Time frame: up to 16 weeks

Secondary outcomes

  1. Percentage change from baseline in UACR compared to placebo

    Time frame: up to 8 weeks

  2. Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.

    Time frame: up to 8 weeks

  3. Plasma concentrations of MT-3995 and its major metabolite

    Time frame: up to 16 weeks

Sponsors and collaborators

Lead sponsor

Tanabe Pharma Corporation

Industry

Registry information

Official study 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

Important dates

Study start
2012
Primary completion
2014
Study completion
2014
First posted
Dec 27, 2012
Registry last updated
Feb 9, 2015

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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