Safety, Tolerability and Pharmacokinetic Study of MT-3995... | NCT02205372

Studies
Safety, Tolerability and Pharmacokinetic Study of MT-3995 at a Low Dose in Subjects With Diabetic Nephropathy

NCT02205372

Sponsor

Tanabe Pharma Corporation

Status

Completed

Last Update Posted

Sep 16, 2015Estimated

Enrollment

31Actual

Phase

Phase 1Phase 2

Conditions

Diabetic Nephropathy

Interventions

MT-3995
Placebo

Countries

Japan

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2015

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jul 2014

Primary Completion Date

Aug 2015Actual

Completion Date

Aug 2015Actual

First Submitted Date

Jul 27, 2014

First Submission Date that Met QC Criteria

Jul 30, 2014

First Posted Date

Jul 31, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 14, 2015

Last Update Posted Date

Sep 16, 2015Estimated

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

Brief Summary

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

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 1Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

31Actual

Label	Type	Description	Intervention Names
MT-3995	Experimental		Drug: MT-3995
Placebo	Placebo Comparator		Drug: Placebo

Name	Type	Description	Arm Group Labels	Other Names
MT-3995	Drug		MT-3995
Placebo

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Frequency and nature of treatment-emergent adverse events and serious adverse events.		20 weeks

Secondary Outcomes

Measure	Description	Time Frame
Plasma concentrations of MT-3995		20 weeks
Plasma concentrations of major metabolite of MT-3995		20 weeks
Change from baseline in Urine albumin-to-creatinine ratio (UACR)

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Subjects with Type 2 diabetes mellitus and diabetic nephropathy, who have been treated with a stable dose of angiotensin converting enzyme-inhibitor (ACE-I) or angiotensin II receptor blocker (ARB)
Glycosylated haemoglobin (HbA1c) ≤10.5%
Subject with albuminuria

Exclusion Criteria:

Subjects with type 1 diabetes mellitus, diabetes mellitus resulting from pancreatic disorder, secondary diabetes mellitus (Cushing's syndrome, steroidogenic diabetes).
Serum potassium level <3.5 or >5.0 mmol/L
Subjects who had acute kidney injury within 3 months prior to baseline or have undergone hemodialysis at any time prior to randomisation
Subjects with clinically significant hypotension

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

75 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Masaomi Nangaku, Professor	Division of Nephrology and Endocrinology University of Tokyo School of medicine	Study Director
Kazuoki Kondou, Adviｓer	Tanabe Pharma Corporation	Study Director

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Touei Hospital		Sapporo	Hokkaido		Japan

Condition Browse Module

MeSH Terms

ID	Term
D003928	Diabetic Nephropathies

Ancestor Terms

ID	Term
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases
D005261	Female Urogenital Diseases and Pregnancy Complications

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
C000719999	apararenone

Ancestor Terms

Not provided

Browse Leaves

Not provided

Browse Branches

Not provided