A Study of RTA 402 in Chronic Kidney Disease (CKD) Patien... | NCT01574365

Studies
A Study of RTA 402 in Chronic Kidney Disease (CKD) Patients With Type 2 Diabetes Mellitus

NCT01574365

Sponsor

Kyowa Kirin Co., Ltd.

Status

Terminated

Last Update Posted

Mar 3, 2017Actual

Enrollment

53Actual

Phase

Phase 2

Conditions

Chronic Kidney Disease
Type 2 Diabetes

Interventions

RTA 402

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

Feb 2017

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 2012

Primary Completion Date

Nov 2013Actual

Completion Date

Nov 2013Actual

First Submitted Date

Apr 4, 2012

First Submission Date that Met QC Criteria

Apr 5, 2012

First Posted Date

Apr 10, 2012Estimated

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

Feb 28, 2017

Last Update Posted Date

Mar 3, 2017Actual

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

A Phase 2 study of RTA 402 in Chronic kidney disease (CKD) patients with type 2 diabetes mellitus.

Detailed Description

To evaluate the efficacy and safety of RTA 402 in patients with type 2 diabetes mellitus.

To evaluate the safety and tolerability of RTA 402.

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 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

53Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
RTA402	Experimental	Drug: RTA 402
RTA402 Low	Experimental	Drug: RTA 402
RTA402 Medium-low	Experimental	Drug: RTA 402
RTA402 Medium-high	Experimental	Drug: RTA 402

Interventions

Name	Type	Description	Arm Group Labels	Other Names
RTA 402	Drug		RTA402 RTA402 Low RTA402 Medium-high RTA402 Medium-low

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Efficacy:Changes in eGFR	Changes in eGFR from baseline to the study week 12 or to the time of treatment discontinuation.	Up to 16 weeks
Adverse event collection and assessment	Adverse Event collection and assessment will be done for all treated subjects.	Up to 16 weeks

Secondary Outcomes

Measure	Description	Time Frame
Profile of Pharmacokinetics	Relationship between the study drug dose and the trough concentration of study drug	Baseline, week 4, 8 and 12.

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

CKD patients with type 2 diabetes mellitus
Patients whose eGFR levels are eligible for this study
Patients being treated with stable dose of ACE inhibitors and/or ARB etc.

Exclusion Criteria:

Patients with Type 1 diabetes
Patients with known non-diabetic renal disease
Patients with a history of renal transplantation
Patients with mean SBP > 160 mmHg or mean DBP > 90 mmHg
Patients with HbA1C > 10%
Patients with cardiovascular disease specified in the study protocol etc.

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

20 Years

Maximum Age

79 Years

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic
D003924	Diabetes Mellitus, Type 2

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided