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

Diabetic Nephropathy Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01935167
• Other study ID #: DW1029M
• Status: Completed
• Phase: Phase 2
• First received: August 30, 2013
• Last updated: February 16, 2017
• Start date: October 2013
• Est. completion date: February 2015

Study information

• Verified date: February 2017
• Source: Dong Wha Pharmaceutical Co. Ltd.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 158
• Est. completion date: February 2015
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 30 Years and older

Eligibility

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.

Related Conditions & MeSH terms

• Diabetic Nephropathies
• Diabetic Nephropathy
• Kidney Diseases

Intervention

Drug:
• DW1029M 600mg
DW1029M 150mg 2 tablets b.i.d
• DW1029M 1200mg
DW1029M 300mg 2 tablets b.i.d
• Placebo
Placebo 2 tablets b.i.d.

Locations

Country	Name	City	State
Korea, Republic of	DongWha Pharm	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Dong Wha Pharmaceutical Co. Ltd.

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

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