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 March 2013 by Mitsubishi Tanabe Pharma Corporation
Sponsor:
Mitsubishi Tanabe Pharma Corporation
Information provided by (Responsible Party):
Mitsubishi Tanabe Pharma Corporation
ClinicalTrials.gov Identifier:
NCT01756716
First received: December 20, 2012
Last updated: March 14, 2013
Last verified: March 2013
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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 macroalbuminuria
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 |
Locations
| Bulgaria | |
| Investigational site | Recruiting |
| Blagoevgrad, Bulgaria | |
| Investigational site | Recruiting |
| Gabrovo, Bulgaria | |
| Investigational site | Recruiting |
| Plovdiv, Bulgaria | |
| Investigational site | Recruiting |
| Ruse, Bulgaria | |
| Investigational site | Recruiting |
| Sofia, Bulgaria | |
| Investigational site | Recruiting |
| Varna, Bulgaria | |
| Czech Republic | |
| Investigational site | Recruiting |
| Cesky Krumlov, Czech Republic | |
| Investigational site | Recruiting |
| Ostrava, Czech Republic | |
| Investigational site | Recruiting |
| Ostrava-Vitkovice, Czech Republic | |
| Investigational site | Recruiting |
| Slany, Czech Republic | |
| Investigational site | Recruiting |
| Znojmo, Czech Republic | |
| Hungary | |
| Investigational site | Recruiting |
| Baja, Hungary | |
| Investigational site | Recruiting |
| Debrecen, Hungary | |
| Investigational site | Recruiting |
| Eger, Hungary | |
| Investigational site | Recruiting |
| Kistelek, Hungary | |
| Investigational site | Recruiting |
| Komarom, Hungary | |
| Investigational site | Recruiting |
| Pecs, Hungary | |
| Investigational site | Recruiting |
| Szigetvar, Hungary | |
| Investigational site | Recruiting |
| Szikszo, Hungary | |
| Investigational site | Recruiting |
| Zalaegerszeg, Hungary | |
| Romania | |
| Investigational site | Recruiting |
| Bacau, Romania | |
| Investigational site | Recruiting |
| Buzau, Romania | |
| Investigational site | Recruiting |
| Cluj-Napoca, Romania | |
| Investigational site | Recruiting |
| Deva, Romania | |
| Investigational site | Recruiting |
| Isai, Romania | |
| Investigational site | Recruiting |
| Oradea, Romania | |
| Investigational site | Recruiting |
| Targu Mures, Romania | |
| Investigational site | Recruiting |
| Timisoara, Romania | |
| Slovakia | |
| Investigational site | Recruiting |
| Banska Bystrica, Slovakia | |
| Investigational site | Recruiting |
| Bardejov, Slovakia | |
| Investigational site | Recruiting |
| Bratislava, Slovakia | |
| Investigational site | Recruiting |
| Levice, Slovakia | |
| Investigational site | Recruiting |
| Lucenec, Slovakia | |
| Investigational site | Recruiting |
| Martin, Slovakia | |
| Investigational site | Recruiting |
| Nitra, Slovakia | |
| Investigational site | Recruiting |
| Presov, Slovakia | |
| Investigational site | Recruiting |
| Sturovo, Slovakia | |
| Investigational site | Recruiting |
| Zilina, Slovakia | |
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: | March 14, 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 |
Keywords provided by Mitsubishi Tanabe Pharma Corporation:
|
Diabetic Nephropathy |
Additional relevant MeSH terms:
|
Albuminuria Diabetic Nephropathies 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 May 19, 2013