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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. The completion date has passed and the status has not been verified in more than two years.
Verified January 2007 by Okayama University.
Recruitment status was:  Recruiting
Information provided by:
Okayama University Identifier:
First received: November 10, 2005
Last updated: January 15, 2007
Last verified: January 2007
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
Intervention Model: Parallel Assignment
Masking: None (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:

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.

Ages Eligible for Study:   20 Years to 75 Years   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT00253786

Contact: Kenichi Shikata, M.D. 086-235-7235

Okayama University Hospital Recruiting
Okayama, Japan, 700-8558
Contact: Kenichi Shikata, M.D.    086-235-7235   
Principal Investigator: Hirofumi Makino, M.D.         
Sponsors and Collaborators
Okayama University
Principal Investigator: Hirofumi Makino, M.D. Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
  More Information Identifier: NCT00253786     History of Changes
Other Study ID Numbers: DNETT-Japan
Study First Received: November 10, 2005
Last Updated: January 15, 2007

Keywords provided by Okayama University:

Additional relevant MeSH terms:
Diabetes Mellitus
Diabetes Mellitus, Type 2
Kidney Diseases
Diabetic Nephropathies
Glucose Metabolism Disorders
Metabolic Diseases
Endocrine System Diseases
Urologic Diseases
Diabetes Complications
Angiotensin-Converting Enzyme Inhibitors
Hydroxymethylglutaryl-CoA Reductase Inhibitors
Protease Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Anticholesteremic Agents
Hypolipidemic Agents
Lipid Regulating Agents processed this record on September 21, 2017