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

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

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

Official Title
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Study for the Effectiveness of Intensive Therapy for Diabetic Nephropathy in Unblinded, Randomized Intergroup Comparison Study.

Conditions
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Type 2 Diabetes Mellitus, Diabetic Nephropathy

Intervention / Treatment
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* Other: Intensive multifactorial therapy
* Other: Standard therapy


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: 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 Criteria: 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

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 75 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Intensive multifactorial therapy (Protocol A)<br>Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. | Other: Intensive multifactorial therapy<br>* Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care<br>|
| Active Comparator: Standard therapy (Protocol A)<br>Protocol A: serum creatinine <1.2 mg/dl in male and <1.0 mg/dl in female. | Other: Standard therapy<br>* Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)<br>|
| Experimental: Intensive multifactorial therapy (Protocol B)<br>Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. | Other: Intensive multifactorial therapy<br>* Blood glucose control: HbA1c < 6.2% Blood pressure control: SBP < 125 mmHg, DBP: < 75 mmHg Lipid profile: T-cho < 180 mg/dl, LDL-cho < 100 mg/dl, HDL-cho >40 mg/dl Dietary intervention: TDEI < 30 kcal/kg/day, sodium < 5 g/day, protein < 0.8 g/kg/day Pharmacological intervention: ACE-Is or ARBs, HMG-CoA reductase inhibitors, multivitamins Instruction by co-medicals: Taking medicines, smoking cessation, nutrition care<br>|
| Active Comparator: Standard therapy (Protocol B)<br>Protocol B: serum creatinine: 1.2-2.5 mg/dl in male and 1.0-2.5 mg/dl in female. | Other: Standard therapy<br>* Blood glucose control: HbA1c < 6.9% Blood pressure control: SBP < 130 mmHg, DBP: < 80 mmHg Lipid profile: T-cho < 200 mg/dl, LDL-cho < 120 mg/dl, HDL-cho >40 mg/dl, Dietary intervention: TDEI < 25-30 kcal/kg/day, sodium < 6 g/day, protein < 1.0 g/kg/day Pharmacological intervention: No restrictions (continuing prior therapy) Instruction by co-medicals: No restrictions (continuing prior therapy)<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A |  | 5 years | 
| 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 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| GFR in Protocol A |  | 5 years | 
| 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 | 
| GFR in Protocol B |  | 5 years | 
| Cardiovascular event in Protocol B |  | 5 years | 
| Progression of retinopathy in Protocol B |  | 5 years | 
| Urinary albumin/creatinine ratio in Protocol B |  | 5 years | 
| Urinary protein/creatinine ratio in Protocol B |  | 5 years | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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diabetes, nephropathy