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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00253786
Recruitment Status : Unknown
Verified January 2007 by Okayama University.
Recruitment status was:  Recruiting
First Posted : November 15, 2005
Last Update Posted : January 17, 2007
Information provided by:
Okayama University

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

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

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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 600 participants
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.
Study Start Date : July 2005
Estimated Study Completion Date : June 2011

Resource links provided by the National Library of Medicine

U.S. FDA Resources

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

Secondary Outcome Measures :
  1. Protocol A:
  2. GFR
  3. Cardiovascular event
  4. Progression of retinopathy
  5. Albumin/creatinine ratio
  6. Albuminuria (collected for 24 hrs.)
  7. Protocol B:
  8. Protein/creatinine ratio

Information from the National Library of Medicine

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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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): 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 Identifier: NCT00253786     History of Changes
Other Study ID Numbers: DNETT-Japan
First Posted: November 15, 2005    Key Record Dates
Last Update Posted: January 17, 2007
Last Verified: January 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