Clinical trial NCT01756716: A Study to Evaluate Pharmacodynamics, Safety, Tolerability and Pharmacokinetics of MT-3995 in Type II Diabetic Nephropathy Subjects With Albuminuria and Moderately Decreased GFR
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
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE2
Conditions: Diabetic Nephropathy
Keywords: Diabetic Nephropathy
Lead sponsor: Mitsubishi Tanabe Pharma Corporation
Sponsor class: INDUSTRY
First posted: 2012-12-27
Enrollment: 49
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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


Eligibility 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

Primary outcomes:
measure: Percentage change from baseline in Urine albumin-to-creatinine ratio (UACR) within group.
timeFrame: up to 8 weeks
measure: Frequency and nature of treatment-emergent adverse events and serious adverse events.
timeFrame: up to 16 weeks
Secondary outcomes:
measure: Percentage change from baseline in UACR compared to placebo
timeFrame: up to 8 weeks
measure: Change from baseline in Systolic Blood Pressure and Diastolic Blood Pressure within group.
timeFrame: up to 8 weeks
measure: Plasma concentrations of MT-3995 and its major metabolite
timeFrame: up to 16 weeks
Other outcomes:
Locations:
city: Blagoevgrad
country: Bulgaria
facility: Investigational site
city: Pazardzhik
country: Bulgaria
facility: Investigational site
city: Pleven
country: Bulgaria
facility: Investigational site
city: Plovdiv
country: Bulgaria
facility: Investigational site
city: Ruse
country: Bulgaria
facility: Investigational site
city: Sofia
country: Bulgaria
facility: Investigational site
city: Varna
country: Bulgaria
facility: Investigational site
city: Ceske Budejovice
country: Czech Republic
facility: Investigational site
city: Cesky Krumlov
country: Czech Republic
facility: Investigational site
city: Karlovy Vary
country: Czech Republic
facility: Investigational site
city: Ostrava-Vitkovice
country: Czech Republic
facility: Investigational site
city: Ostrava
country: Czech Republic
facility: Investigational site
city: Praha
country: Czech Republic
facility: Investigational site
city: Slany
country: Czech Republic
facility: Investigational site
city: Znojmo
country: Czech Republic
facility: Investigational site
city: Baja
country: Hungary
facility: Investigational site
city: Budapest
country: Hungary
facility: Investigational site
city: Debrecen
country: Hungary
facility: Investigational site
city: Eger
country: Hungary
facility: Investigational site
city: Kistelek
country: Hungary
facility: Investigational site
city: Komarom
country: Hungary
facility: Investigational site
city: Pecs
country: Hungary
facility: Investigational site
city: Szigetvar
country: Hungary
facility: Investigational site
city: Szikszo
country: Hungary
facility: Investigational site
city: Zalaegerszeg
country: Hungary
facility: Investigational site
city: Krakow
country: Poland
facility: Investigational site
city: Ruda Slaska
country: Poland
facility: Investigational site
city: Rzeszow
country: Poland
facility: Investigational site
city: Swietochlowice
country: Poland
facility: Investigational site
city: Bacau
country: Romania
facility: Investigational site
city: Braila
country: Romania
facility: Investigational site
city: Bucuresti
country: Romania
facility: Investigational site
city: Buzau
country: Romania
facility: Investigational site
city: Cluj-Napoca
country: Romania
facility: Investigational site
city: Deva
country: Romania
facility: Investigational site
city: Iasi
country: Romania
facility: Investigational site
city: Oradea
country: Romania
facility: Investigational site
city: Ploiesti, Judet Prahova
country: Romania
facility: Investigational site
city: Satu Mare
country: Romania
facility: Investigational site
city: Targu Mures
country: Romania
facility: Investigational site
city: Timisoara
country: Romania
facility: Investigational site
city: Bardejov
country: Slovakia
facility: Investigational site
city: Bratislava
country: Slovakia
facility: Investigational site
city: Levice
country: Slovakia
facility: Investigational site
city: Lucenec
country: Slovakia
facility: Investigational site
city: Martin
country: Slovakia
facility: Investigational site
city: Nitra
country: Slovakia
facility: Investigational site
city: Presov
country: Slovakia
facility: Investigational site
city: Sahy
country: Slovakia
facility: Investigational site
city: Sturovo
country: Slovakia
facility: Investigational site
Study officials:
References: