Status:
COMPLETED
Study for the Effectiveness of Intensive Therapy Aiming at a Remission of Diabetic Nephropathy
Lead Sponsor:
Okayama University
Conditions:
Type 2 Diabetes Mellitus
Diabetic Nephropathy
Eligibility:
All Genders
20-75 years
Phase:
NA
Brief Summary
Study for the effectiveness of intensive therapy aiming at the remission of diabetic nephropathy
Detailed Description
Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Eligibility Criteria
Inclusion
- Patients with type 2 diabetes
- Urinary albumin-to-creatinine ratio: \>=300 mg/g creatinine twice in the first morning urine sample
- Serum creatinine level: =\<2.5 mg/dl
- Patients aged 20-75 years
Exclusion
- Type 1 diabetes
- Hereditary diabetes or secondary diabetes
- Non-diabetic nephropathy
- Familial hypercholesterolemia
- Secondary hypertension
- Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
- Malignant tumor or life threatening disease
- History of angioedema
- Patients undergoing LDL apheresis
- Biliary system obstruction or severe liver injury
- Liver dysfunction
- Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
- Pregnant or nursing patients
- Others: patients who are not suitable for this trial
Key Trial Info
Start Date :
November 11 2005
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
November 27 2014
Estimated Enrollment :
312 Patients enrolled
Trial Details
Trial ID
NCT00253786
Start Date
November 11 2005
End Date
November 27 2014
Last Update
July 23 2019
Active Locations (1)
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1
Okayama University Hospital
Okayama, Japan, 700-8558