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Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy

The recruitment status of this study is unknown because the information has not been verified recently.
Verified January 2007 by Okayama University.
Recruitment status was  Recruiting
Sponsor:
Information provided by:
Okayama University
ClinicalTrials.gov Identifier:
NCT00253786
First received: November 10, 2005
Last updated: January 15, 2007
Last verified: January 2007
History of Changes
  Purpose

Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy


Condition Intervention
Type 2 Diabetes Mellitus
Diabetic Nephropathy
 Drug: ACE inhibitors,ARB, HMG-CoA reductase inhibitors, vitamins
Behavioral: Compliance, antismoking, and nutrition instruction

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Okayama University:

Primary Outcome Measures:
  • Protein/creatinine ratio in albuminuria(first urine in early-morning)

Secondary Outcome Measures:
  • Protocol A:
  • GFR
  • Cardiovascular event
  • Progression of retinopathy
  • Albumin/creatinine ratio
  • Albuminuria (collected for 24 hrs.)
  • Protocol B:
  • Protein/creatinine ratio

Estimated Enrollment: 600
Study Start Date: July 2005
Estimated Study Completion Date: June 2011
Detailed Description:

Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.

  Eligibility

Ages Eligible for Study:   20 Years to 75 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Type 2 diabetes mellitus
  • Urinary albumin/creatinine ratio >= 300mg/gCr
  • Serum creatinine level <2.5mg/dL through the observation period
  • Patients whose consent is obtained at age >20 years or =<75 years

Exclusion Criteria:

  • Type 1 diabetes mellitus
  • Hereditary diabetes mellitus or secondary diabetes mellitus
  • Non-diabetic nephropathy
  • Familial hypercholesterolemia
  • Secondary hypertension
  • Unstable angina pectoris
  • Myocardial infarction
  • Cerebral hemorrhage
  • Life-threatening disease such as malignant tumor
  • History of angioedema
  • Under LDL-apheresis by a adsorbent with dextran sulphate cellose
  • Biliary obstruction
  • Severe hepatopathy
  • Hypergasia of hepatic metabolism such as acute hepatitis
  • Exacerbation of chronic hepatitis
  • Cirrhosis
  • Hepatic cancer
  • Jaundice
  • History of hypersensitivity against ACE inhibitors
  • History of hypersensitivity against ARB
  • History of hypersensitivity against HMG-CoA reductase inhibitors
  • Pregnant, lactating, and probably pregnant patients
  • Patients who want to become pregnant during the study period
  • Patients judged as being inappropriate for the subjects
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00253786

Contacts
Contact: Kenichi Shikata, M.D. 086-235-7235 shikata@md.okayama-u.ac.jp

Locations
Japan
Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: Kenichi Shikata, M.D.     086-235-7235     shikata@md.okayama-u.ac.jp    
Principal Investigator: Hirofumi Makino, M.D.            
Sponsors and Collaborators
Okayama University
Investigators
Principal Investigator: Hirofumi Makino, M.D. Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  More Information

No publications provided

ClinicalTrials.gov Identifier: NCT00253786     History of Changes
Other Study ID Numbers: DNETT-Japan
Study First Received: November 10, 2005
Last Updated: January 15, 2007
Health Authority: Japan: Ministry of Health, Labor and Welfare

Keywords provided by Okayama University:
diabetes
nephropathy

Additional relevant MeSH terms:
Diabetic Nephropathies
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Angiotensin-Converting Enzyme Inhibitors
Vitamins
Hydroxymethylglutaryl-CoA Reductase Inhibitors
 Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Pharmacologic Actions
Micronutrients
Growth Substances
Physiological Effects of Drugs
Anticholesteremic Agents
Hypolipidemic Agents
Antimetabolites
Lipid Regulating Agents
Therapeutic Uses

ClinicalTrials.gov processed this record on June 17, 2013