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

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

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

Study Overview

• Status: Completed
• Conditions: Diabetic Nephropathy
• Intervention / Treatment: Drug: DW1029M 600mg; Drug: DW1029M 1200mg; Drug: Placebo

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

• Study Type: Interventional
• Enrollment (Actual): 158
• Phase: Phase 2

Contacts and Locations

Study Locations

• Korea, Republic of
  • Seoul, Korea, Republic of, 100-130
    • DongWha Pharm

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 30 years and older (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: Double

Number of Arms

3

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Group; DW1029M 600mg for 24 weeks	Drug: DW1029M 600mg; DW1029M 150mg 2 tablets b.i.d; Other Names: DW1029M 150mg 2 tablets
Experimental: B Group; DW1029M 1200mg for 24 weeks	Drug: DW1029M 1200mg; DW1029M 300mg 2 tablets b.i.d; Other Names: DW1029M 300mg 4 tablets
Placebo Comparator: C Group; Placebo for 24 weeks	Drug: Placebo; Placebo 2 tablets b.i.d.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
log ACR	logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks	24 weeks after 1st administration

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Log UAE	Urinary Albumin Excretion(UAE) after 12 and 24 weeks	24 weeks after 1st administration
eGFR	estimated Glomerular Filtration Rate(eGFR) after 12 and 24 weeks	12 and 24 weeks after 1st administration
log ACR	logarithm of the Albumin Creatinine Ratio(ACR) after 12 weeks	12 weeks after 1st administration
SCC	Serum Creatinine Concentration(SCC) after 12 and 24 weeks	12 and 24 weeks after 1st administration
Cystatin C	Cystatin C after 12 and 24 weeks	12 and 24 weeks after 1st administration

Collaborators and Investigators

• Sponsor: Dong Wha Pharmaceutical Co. Ltd.
• Investigators: Principal Investigator: MoonKyu Lee, Professor, Samsung Medical Center

Study record dates

Study Major Dates

• Study Start: October 1, 2013
• Primary Completion (Actual): August 1, 2014
• Study Completion (Actual): February 1, 2015

Study Registration Dates

• First Submitted: August 30, 2013
• First Submitted That Met QC Criteria: September 3, 2013
• First Posted (Estimate): September 4, 2013

Study Record Updates

• Last Update Posted (Actual): February 17, 2017
• Last Update Submitted That Met QC Criteria: February 16, 2017
• Last Verified: February 1, 2017

More Information

Terms related to this study

• Keywords: Microalbuminuria
• Additional Relevant MeSH Terms: Urologic Diseases; Endocrine System Diseases; Diabetes Complications; Diabetes Mellitus; Kidney Diseases; Diabetic Nephropathies
• Other Study ID Numbers: DW1029M

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO