NCT01574365

Brief Summary

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

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
53

participants targeted

Target at P25-P50 for phase_2

Timeline
Completed

Started Feb 2012

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

February 1, 2012

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

April 4, 2012

Completed
6 days until next milestone

First Posted

Study publicly available on registry

April 10, 2012

Completed
1.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2013

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

November 1, 2013

Completed
Last Updated

March 3, 2017

Status Verified

February 1, 2017

Enrollment Period

1.8 years

First QC Date

April 4, 2012

Last Update Submit

February 28, 2017

Conditions

Chronic Kidney DiseaseType 2 Diabetes

Keywords

CKD patients with type 2 diabetes

Outcome Measures

Primary Outcomes (2)

  • 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 (1)

  • Profile of Pharmacokinetics

    Baseline, week 4, 8 and 12.

Study Arms (4)

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

RTA 402DRUG
RTA402RTA402 LowRTA402 Medium-highRTA402 Medium-low

Eligibility Criteria

Age20 Years - 79 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Unknown Facility

Toride, Ibaraki, Japan

Location

MeSH Terms

Conditions

Renal Insufficiency, ChronicDiabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and SymptomsDiabetes MellitusGlucose Metabolism DisordersMetabolic DiseasesNutritional and Metabolic DiseasesEndocrine System Diseases

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

April 4, 2012

First Posted

April 10, 2012

Study Start

February 1, 2012

Primary Completion

November 1, 2013

Study Completion

November 1, 2013

Last Updated

March 3, 2017

Record last verified: 2017-02

Locations

JP(1)