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

Okayama University

Status: Completed

Conditions: Diabetic Nephropathy; Type 2 Diabetes Mellitus

Treatments: Other: Intensive multifactorial therapy; Other: Standard therapy

Study type: Interventional

Funder types: Other

Identifiers

NCT00253786

DNETT-Japan

Details and patient eligibility

About

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

Full description

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

Enrollment: 312 patients

Sex: All

Ages: 20 to 75 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

1. Patients with type 2 diabetes
2. Urinary albumin-to-creatinine ratio: >=300 mg/g creatinine twice in the first morning urine sample
3. Serum creatinine level: =<2.5 mg/dl
4. Patients aged 20-75 years

Exclusion criteria

1. Type 1 diabetes
2. Hereditary diabetes or secondary diabetes
3. Non-diabetic nephropathy
4. Familial hypercholesterolemia
5. Secondary hypertension
6. Unstable angina pectoris or history of myocardial infarction/stroke within 6 months prior to consent acquisition
7. Malignant tumor or life threatening disease
8. History of angioedema
9. Patients undergoing LDL apheresis
10. Biliary system obstruction or severe liver injury
11. Liver dysfunction
12. Allergy for ACE-Is, ARBs or HMG-CoA reductase inhibitors
13. Pregnant or nursing patients
14. Others: patients who are not suitable for this trial

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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312 participants in 4 patient groups

Intensive multifactorial therapy (Protocol A)

Experimental group

Description:

Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.

Treatment:

Other: Intensive multifactorial therapy

Standard therapy (Protocol A)

Active Comparator group

Description:

Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.

Treatment:

Other: Standard therapy

Intensive multifactorial therapy (Protocol B)

Experimental group

Description:

Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.

Treatment:

Other: Intensive multifactorial therapy

Standard therapy (Protocol B)

Active Comparator group

Description:

Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.

Treatment:

Other: Standard therapy