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

Phase 2

Completed

• Conditions: Diabetic Nephropathy
• Interventions: Drug: DW1029M 1200mg; Drug: Placebo; Drug: DW1029M 600mg

• Registration Number: NCT01935167
• Lead Sponsor: Dong Wha Pharmaceutical Co. Ltd.

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

Study Timeline

• Study First Submitted: 2013-08-30
• Study First Submitted QC: 2013-09-03
• Study First Posted: 2013-09-04
• Study Start: 2013-10
• Primary Completion: 2014-08
• Study Completion: 2015-02
• Status Verified: 2017-02
• Last Update Submitted: 2017-02-16
• Last Update Posted: 2017-02-17

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 158

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 & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
B Group	DW1029M 1200mg	DW1029M 1200mg for 24 weeks
C Group	Placebo	Placebo for 24 weeks
A Group	DW1029M 600mg	DW1029M 600mg for 24 weeks

Primary Outcome Measures

Name	Time	Method
log ACR	24 weeks after 1st administration	logarithm of the Albumin Creatinine Ratio(ACR) after 24 weeks

Secondary Outcome Measures

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

Trial Locations

Locations (1)

DongWha Pharm; 🇰🇷 Seoul, Korea, Republic of