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

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01756716
• Other study ID #: MT-3995-E07
• Status: Completed
• Phase: Phase 2
• First received: December 20, 2012
• Last updated: February 5, 2015
• Start date: December 2012
• Est. completion date: September 2014

Study information

• Verified date: February 2015
• Source: Mitsubishi Tanabe Pharma Corporation
• Contact: n/a
• Is FDA regulated: No
• Health authority: Czech Republic: State Institute for Drug ControlHungary: National Institute of PharmacyBulgaria: Bulgarian Drug AgencyRomania: Ministry of Public HealthSlovakia: State Institute for Drug ControlPoland: Office for Registration of Medicinal Products
• Study type: Interventional

Clinical Trial 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 and Moderately Decreased GFR

Recruitment information / eligibility

• Status: Completed
• Enrollment: 49
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 75 Years

Eligibility

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 ß-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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Albuminuria
• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• MT-3995 Low
MT-3995 Low dose for 8 weeks
• MT-3995 High
MT-3995 High dose for 8 weeks
• Placebo
Placebo for 8 weeks

Locations

Country	Name	City	State
Bulgaria	Investigational site	Blagoevgrad
Bulgaria	Investigational site	Pazardzhik
Bulgaria	Investigational site	Pleven
Bulgaria	Investigational site	Plovdiv
Bulgaria	Investigational site	Ruse
Bulgaria	Investigational site	Sofia
Bulgaria	Investigational site	Varna
Czech Republic	Investigational site	Ceske Budejovice
Czech Republic	Investigational site	Cesky Krumlov
Czech Republic	Investigational site	Karlovy Vary
Czech Republic	Investigational site	Ostrava
Czech Republic	Investigational site	Ostrava-Vitkovice
Czech Republic	Investigational site	Praha
Czech Republic	Investigational site	Slany
Czech Republic	Investigational site	Znojmo
Hungary	Investigational site	Baja
Hungary	Investigational site	Budapest
Hungary	Investigational site	Debrecen
Hungary	Investigational site	Eger
Hungary	Investigational site	Kistelek
Hungary	Investigational site	Komarom
Hungary	Investigational site	Pecs
Hungary	Investigational site	Szigetvar
Hungary	Investigational site	Szikszo
Hungary	Investigational site	Zalaegerszeg
Poland	Investigational site	Krakow
Poland	Investigational site	Ruda Slaska
Poland	Investigational site	Rzeszow
Poland	Investigational site	Swietochlowice
Romania	Investigational site	Bacau
Romania	Investigational site	Braila
Romania	Investigational site	Bucuresti
Romania	Investigational site	Buzau
Romania	Investigational site	Cluj-Napoca
Romania	Investigational site	Deva
Romania	Investigational site	Iasi
Romania	Investigational site	Oradea
Romania	Investigational site	Ploiesti, Judet Prahova
Romania	Investigational site	Satu Mare
Romania	Investigational site	Targu Mures
Romania	Investigational site	Timisoara
Slovakia	Investigational site	Bardejov
Slovakia	Investigational site	Bratislava
Slovakia	Investigational site	Levice
Slovakia	Investigational site	Lucenec
Slovakia	Investigational site	Martin
Slovakia	Investigational site	Nitra
Slovakia	Investigational site	Presov
Slovakia	Investigational site	Sahy
Slovakia	Investigational site	Sturovo

Sponsors (1)

Lead Sponsor	Collaborator
Mitsubishi Tanabe Pharma Corporation

Countries where clinical trial is conducted

Bulgaria,  Czech Republic,  Hungary,  Poland,  Romania,  Slovakia, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.		up to 8 weeks	No
Primary	Frequency and nature of treatment-emergent adverse events and serious adverse events.		up to 16 weeks	Yes
Secondary	Percentage change from baseline in UACR compared to placebo		up to 8 weeks	No
Secondary	Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.		up to 8 weeks	No
Secondary	Plasma concentrations of MT-3995 and its major metabolite		up to 16 weeks	No