Trial record 15 of 59 for:    Open Studies | "Diabetic Nephropathies"

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

This study is currently recruiting participants.
Verified December 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01756716
First received: December 20, 2012
Last updated: December 24, 2013
Last verified: December 2013
  Purpose

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


Condition Intervention Phase
Diabetic Nephropathy
Drug: MT-3995 Low
Drug: MT-3995 High
Drug: Placebo
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Investigator)
Primary Purpose: Treatment
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 ≥30-<60 mL/Min/1.73m^2

Resource links provided by NLM:


Further study details as provided by Mitsubishi Tanabe Pharma Corporation:

Primary Outcome Measures:
  • Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Frequency and nature of treatment-emergent adverse events and serious adverse events. [ Time Frame: up to 16 weeks ] [ Designated as safety issue: Yes ]

Secondary Outcome Measures:
  • Percentage change from baseline in UACR compared to placebo [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group. [ Time Frame: up to 8 weeks ] [ Designated as safety issue: No ]
  • Plasma concentrations of MT-3995 and its major metabolite [ Time Frame: up to 16 weeks ] [ Designated as safety issue: No ]

Estimated Enrollment: 90
Study Start Date: December 2012
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: December 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: MT-3995 Low group Drug: MT-3995 Low
MT-3995 Low dose for 8 weeks
Experimental: MT-3995 High group Drug: MT-3995 High
MT-3995 High dose for 8 weeks
Placebo Comparator: Placebo group Drug: Placebo
Placebo for 8 weeks

  Eligibility

Ages Eligible for Study:   18 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

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) ≥30-<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
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01756716

Contacts
Contact: Information Desk at Mitsubishi Pharma Europe information@mitsubishi-pharma.eu

  Show 50 Study Locations
Sponsors and Collaborators
Mitsubishi Tanabe Pharma Corporation
  More Information

No publications provided

Responsible Party: Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier: NCT01756716     History of Changes
Other Study ID Numbers: MT-3995-E07
Study First Received: December 20, 2012
Last Updated: December 24, 2013
Health Authority: Czech Republic: State Institute for Drug Control
Hungary: National Institute of Pharmacy
Bulgaria: Bulgarian Drug Agency
Romania: Ministry of Public Health
Slovakia: State Institute for Drug Control
Poland: Office for Registration of Medicinal Products

Keywords provided by Mitsubishi Tanabe Pharma Corporation:
Diabetic Nephropathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Albuminuria
Kidney Diseases
Proteinuria
Urination Disorders
Urologic Diseases
Urological Manifestations
Signs and Symptoms
Diabetes Complications
Diabetes Mellitus
Endocrine System Diseases

ClinicalTrials.gov processed this record on April 17, 2014