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To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

Primary Purpose

Diabetic Nephropathy

Status
Completed
Phase
Phase 2
Locations
Korea, Republic of
Study Type
Interventional
Intervention
DW1029M 600mg
DW1029M 1200mg
Placebo
Sponsored by
Dong Wha Pharmaceutical Co. Ltd.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Diabetic Nephropathy focused on measuring Microalbuminuria

Eligibility Criteria

30 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

Inclusion Criteria:

  • 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

Exclusion Criteria:

  • 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.

Sites / Locations

  • DongWha Pharm

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Experimental

Experimental

Placebo Comparator

Arm Label

A Group

B Group

C Group

Arm Description

DW1029M 600mg for 24 weeks

DW1029M 1200mg for 24 weeks

Placebo for 24 weeks

Outcomes

Primary Outcome Measures

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

Secondary Outcome Measures

Log UAE
Urinary Albumin Excretion(UAE) after 12 and 24 weeks
eGFR
estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks
log ACR
logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks
SCC
Serum Creatinine Concentration(SCC) after 12 and 24 weeks
Cystatin C
Cystatin C after 12 and 24 weeks

Full Information

First Posted
August 30, 2013
Last Updated
February 16, 2017
Sponsor
Dong Wha Pharmaceutical Co. Ltd.
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1. Study Identification

Unique Protocol Identification Number
NCT01935167
Brief Title
To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Official Title
A Phase Ⅱ, Prospective, 24 Weeks, Double-blind, Placebo-controlled, Randomized, Multi-center Clinical Trial for the Evaluation of the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy
Study Type
Interventional

2. Study Status

Record Verification Date
February 2017
Overall Recruitment Status
Completed
Study Start Date
October 2013 (undefined)
Primary Completion Date
August 2014 (Actual)
Study Completion Date
February 2015 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Dong Wha Pharmaceutical Co. Ltd.

4. Oversight

Data Monitoring Committee
No

5. Study Description

Brief Summary
Phase 2 clinical study to evaluate of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy
Detailed Description
A Phase Ⅱ, prospective, 24 weeks, double-blind, placebo-controlled, randomized, multi-center clinical trial for the evaluation of the efficacy and safety of DW1029M on microalbuminuria in Patients With Diabetic Nephropathy

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Diabetic Nephropathy
Keywords
Microalbuminuria

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
158 (Actual)

8. Arms, Groups, and Interventions

Arm Title
A Group
Arm Type
Experimental
Arm Description
DW1029M 600mg for 24 weeks
Arm Title
B Group
Arm Type
Experimental
Arm Description
DW1029M 1200mg for 24 weeks
Arm Title
C Group
Arm Type
Placebo Comparator
Arm Description
Placebo for 24 weeks
Intervention Type
Drug
Intervention Name(s)
DW1029M 600mg
Other Intervention Name(s)
DW1029M 150mg 2 tablets
Intervention Description
DW1029M 150mg 2 tablets b.i.d
Intervention Type
Drug
Intervention Name(s)
DW1029M 1200mg
Other Intervention Name(s)
DW1029M 300mg 4 tablets
Intervention Description
DW1029M 300mg 2 tablets b.i.d
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo 2 tablets b.i.d.
Primary Outcome Measure Information:
Title
log ACR
Description
logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks
Time Frame
24 weeks after 1st administration
Secondary Outcome Measure Information:
Title
Log UAE
Description
Urinary Albumin Excretion(UAE) after 12 and 24 weeks
Time Frame
24 weeks after 1st administration
Title
eGFR
Description
estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks
Time Frame
12 and 24 weeks after 1st administration
Title
log ACR
Description
logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks
Time Frame
12 weeks after 1st administration
Title
SCC
Description
Serum Creatinine Concentration(SCC) after 12 and 24 weeks
Time Frame
12 and 24 weeks after 1st administration
Title
Cystatin C
Description
Cystatin C after 12 and 24 weeks
Time Frame
12 and 24 weeks after 1st administration

10. Eligibility

Sex
All
Minimum Age & Unit of Time
30 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria: 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 Exclusion Criteria: 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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
MoonKyu Lee, Professor
Organizational Affiliation
Samsung Medical Center
Official's Role
Principal Investigator
Facility Information:
Facility Name
DongWha Pharm
City
Seoul
ZIP/Postal Code
100-130
Country
Korea, Republic of

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

To Determine the Efficacy and Safety of DW1029M on Microalbuminuria in Patients With Diabetic Nephropathy

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