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

UMIN ID: C000000280

Registered date:16/11/2005

Basic Information

• Health condition(s) or Problem(s) studied: Diabetic Nephropathy
• Date of first enrollment: 2005/07/01
• Target sample size: 600
• Countries of recruitment: Japan
• Study type: Interventional

Intervention(s)

Drug Therapy:1.Integrated therapy group: ACE inhibitors or ARB, HMG-CoA reductase inhibitors, multi-vitamins2. Conventional therapy group: Not limited (Continuation of conventional therapy)
Guidance by Diabetes Medical Instructors:1.Integrated therapy group: Patient compliance instruction, antismoking instruction, nutrition instruction2.Conventional therapy group: Not limited (Continuation of conventional therapy)

Outcome(s)

• Primary Outcome: Protein/creatinine ratio in albuminuria(first urine in early-morning)
• Secondary Outcome: Protocol A:1) GFR 2) cardiovascular event 3) progression of retinopathy 4) albumin/creatinine ratio 5)albuminuria (collected for 24 hrs.) Protocol B:1)GFR 2)cardiovascular event 3)progression of retinopathy 4)albumin/creatinine ratio 5)protein/creatinine ratio

Key inclusion & exclusion criteria

• Age minimum: 20years-old
• Age maximum: 75years-old
• Gender: Male and Female
• Exclude criteria: Patients who fall into the following categories are not eligible:1) Patients with type 1 diabetes mellitus2) Patients with hereditary diabetes mellitus or secondary diabetes mellitus.3) Patients with non-diabetic nephropathy, e.g., glomerular nephritis, lupus nephritis.4) Patients with familial hypercholesterolemia.5) Patients with secondary hypertension.6) Patients with unstable angina pectoris, or patients who have developed myocardial infarction or cerebral hemorrhage within 6 months prior to the observation period.7) Patients with any life-threatening disease which will be the cause of death within five years such as malignant tumor.8) Patients with a history of angio edema.9) Patients under LDL-apheresis by a adsorber with dextran sulphate cellose.10) Patients with biliary obstruction or severe hepatopathy.11) Patients considered as having hypergasia of hepatic metabolism such as acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis, hepatic cancer, or jaundice.12) Patients with a history of hypersensitivity against ACE inhibitors, ARBs, or HMG-CoA reductase inhibitors.13) 0patiens, and patients who want to become pregnant during the study period.14) Other patients judged as being inappropriate for the subjects of the study by investigators.

Related Information

• Primary Sponsor: Okayama University Hospital
• Source(s) of Monetary Support: Health, Labor and Welfare Ministry
• Secondary ID(s): NCT00253786