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

Not Applicable

Completed

• Conditions: Type 2 Diabetes Mellitus; Diabetic Nephropathy
• Interventions: Other: Standard therapy; Other: Intensive multifactorial therapy

• Registration Number: NCT00253786
• Lead Sponsor: Okayama University

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.

Study Timeline

• Study First Submitted: 2005-11-10
• Study First Submitted QC: 2005-11-10
• Study Start: 2005-11-11
• Study First Posted: 2005-11-15
• Primary Completion: 2014-11-27
• Study Completion: 2014-11-27
• Status Verified: 2019-07
• Last Update Submitted: 2019-07-19
• Last Update Posted: 2019-07-23

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 312

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Standard therapy (Protocol A)	Standard therapy	Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.
Intensive multifactorial therapy (Protocol A)	Intensive multifactorial therapy	Protocol A: serum creatinine \<1.2 mg/dl in male and \<1.0 mg/dl in female.
Intensive multifactorial therapy (Protocol B)	Intensive multifactorial therapy	Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.
Standard therapy (Protocol B)	Standard therapy	Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female.

Primary Outcome Measures

Name	Time	Method
Composite endpoint of time to first occurrence of (1) Doubling of serum creatinine, (2) Need for chronic dialysis or renal transplantation, or (3) Death in Protocol B	5 years
Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A	5 years

Secondary Outcome Measures

Name	Time	Method
Cardiovascular event in Protocol A	5 years
Progression of retinopathy in Protocol A	5 years
Urinary albumin/creatinine ratio in Protocol A	5 years
Proteinuria (24 h collection sample) in Protocol A	5 years
Cardiovascular event in Protocol B	5 years
Progression of retinopathy in Protocol B	5 years
GFR in Protocol A	5 years
GFR in Protocol B	5 years
Urinary protein/creatinine ratio in Protocol B	5 years
Urinary albumin/creatinine ratio in Protocol B	5 years

Trial Locations

Locations (1)

Okayama University Hospital; 🇯🇵 Okayama, Japan