NCT01935167

Brief Summary

Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

Trial Health

87
On Track

Trial Health Score

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

Enrollment
158

participants targeted

Target at P75+ for phase_2

Timeline
Completed

Started Oct 2013

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
completed

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

First Submitted

Initial submission to the registry

August 30, 2013

Completed
5 days until next milestone

First Posted

Study publicly available on registry

September 4, 2013

Completed
27 days until next milestone

Study Start

First participant enrolled

October 1, 2013

Completed
10 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2014

Completed
6 months until next milestone

Study Completion

Last participant's last visit for all outcomes

February 1, 2015

Completed
Last Updated

February 17, 2017

Status Verified

February 1, 2017

Enrollment Period

10 months

First QC Date

August 30, 2013

Last Update Submit

February 16, 2017

Conditions

Diabetic Nephropathy

Keywords

Microalbuminuria

Outcome Measures

Primary Outcomes (1)

  • log ACR

    logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks

    24 weeks after 1st administration

Secondary Outcomes (5)

  • Log UAE

    24 weeks after 1st administration

  • eGFR

    12 and 24 weeks after 1st administration

  • log ACR

    12 weeks after 1st administration

  • SCC

    12 and 24 weeks after 1st administration

  • Cystatin C

    12 and 24 weeks after 1st administration

Study Arms (3)

A Group

EXPERIMENTAL

DW1029M 600mg for 24 weeks

Drug: DW1029M 600mg

B Group

EXPERIMENTAL

DW1029M 1200mg for 24 weeks

Drug: DW1029M 1200mg

C Group

PLACEBO COMPARATOR

Placebo for 24 weeks

Drug: Placebo

Interventions

DW1029M 600mgDRUG

DW1029M 150mg 2 tablets b.i.d

Also known as: DW1029M 150mg 2 tablets
A Group
DW1029M 1200mgDRUG

DW1029M 300mg 2 tablets b.i.d

Also known as: DW1029M 300mg 4 tablets
B Group
PlaceboDRUG

Placebo 2 tablets b.i.d.

C Group

Eligibility Criteria

Age30 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • Has confirmed diabetic mellitus prior to 6years
  • Has confirmed microalbuminuria 30 \~ 299㎍/㎎creatinine prior to 5months one time and microalbuminuria 30 \~ 299㎍/㎎creatinine during screening period
  • Blood Pressure(BP) ≤ 150 / 90 mmHg
  • estimated glomerular filtration rate(eGFR) ≥ 30 ml/min/1.73m2
  • Hemoglobin A1c(HbA1c) ≤ 9%
  • Low density lipoprotein(LDL-C) ≤ 130mg/dl

You may not qualify if:

  • kidney or liver disease as follows i.Serum Creatinine \> 2.0mg/dl ii.Alanine Aminotransferase(ALT) or Aspartate Aminotransferase(AST) \> 2 x Upper Limit Normal(ULN) iii.Total Bilirubin \> 2 x ULN
  • Organic gastrointestinal disorder or Chronic gastroenterologic disorders prior to 6 months as follows \[NOTE\] Active Crohn's disease, Active ulcerative colitis, Chronic peptic ulcer disease, etc.
  • cardiovascular disease prior to 3 months as follows \[NOTE\] Unstable angina pectoris, Myocardial infarction, Coronary artery bypass surgery, Percutaneous Transluminal Coronary Angioplasty, transient ischemic attack, cerebrovascular accident etc.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

DongWha Pharm

Seoul, Seoul, 100-130, South Korea

Location

MeSH Terms

Conditions

Diabetic Nephropathies

Condition Hierarchy (Ancestors)

Kidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesDiabetes ComplicationsDiabetes MellitusEndocrine System Diseases

Study Officials

  • MoonKyu Lee, Professor

    Samsung Medical Center

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

August 30, 2013

First Posted

September 4, 2013

Study Start

October 1, 2013

Primary Completion

August 1, 2014

Study Completion

February 1, 2015

Last Updated

February 17, 2017

Record last verified: 2017-02

Data Sharing

IPD Sharing
Will not share

Locations

KR(1)