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

Primary Purpose

Type 2 Diabetes Mellitus, Diabetic Nephropathy

Status

Completed

Phase

Not Applicable

Locations

Japan

Study Type

Interventional

Intervention

Intensive multifactorial therapy

Standard therapy

About this trial

This is an interventional treatment trial for Type 2 Diabetes Mellitus focused on measuring diabetes, nephropathy

Eligibility Criteria

20 Years - 75 Years (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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

Sites / Locations

Okayama University Hospital

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Active Comparator

Experimental

Active Comparator

Arm Label

Intensive multifactorial therapy (Protocol A)

Standard therapy (Protocol A)

Intensive multifactorial therapy (Protocol B)

Standard therapy (Protocol B)

Arm Description

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

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

Outcomes

Primary Outcome Measures

Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A

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

Secondary Outcome Measures

GFR in Protocol A

Cardiovascular event in Protocol A

Progression of retinopathy in Protocol A

Urinary albumin/creatinine ratio in Protocol A

Proteinuria (24 h collection sample) in Protocol A

GFR in Protocol B

Cardiovascular event in Protocol B

Progression of retinopathy in Protocol B

Urinary albumin/creatinine ratio in Protocol B

Urinary protein/creatinine ratio in Protocol B

Full Information

NCT ID

NCT00253786

First Posted

November 10, 2005

Last Updated

July 19, 2019

Sponsor

Okayama University

1. Study Identification

Unique Protocol Identification Number

NCT00253786

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

July 2019

Overall Recruitment Status

Completed

Study Start Date

November 11, 2005 (Actual)

Primary Completion Date

November 27, 2014 (Actual)

Study Completion Date

November 27, 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Principal Investigator

Name of the Sponsor

Okayama University

4. Oversight

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Type 2 Diabetes Mellitus, Diabetic Nephropathy

Keywords

diabetes, nephropathy

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

312 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Intensive multifactorial therapy (Protocol A)

Arm Type

Experimental

Arm Description

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

Arm Title

Standard therapy (Protocol A)

Arm Type

Active Comparator

Arm Description

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

Arm Title

Intensive multifactorial therapy (Protocol B)

Arm Type

Experimental

Arm Description

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

Arm Title

Standard therapy (Protocol B)

Arm Type

Active Comparator

Arm Description

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

Intervention Type

Other

Intervention Name(s)

Intensive multifactorial therapy

Intervention Description

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

Intervention Type

Other

Intervention Name(s)

Standard therapy

Intervention Description

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)

Primary Outcome Measure Information:

Title

Urinary protein/creatinine ratio (in the first morning urine sample) in Protocol A

Time Frame

5 years

Title

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

Time Frame

5 years

Secondary Outcome Measure Information:

Title

GFR in Protocol A

Time Frame

5 years

Title

Cardiovascular event in Protocol A

Time Frame

5 years

Title

Progression of retinopathy in Protocol A

Time Frame

5 years

Title

Urinary albumin/creatinine ratio in Protocol A

Time Frame

5 years

Title

Proteinuria (24 h collection sample) in Protocol A

Time Frame

5 years

Title

GFR in Protocol B

Time Frame

5 years

Title

Cardiovascular event in Protocol B

Time Frame

5 years

Title

Progression of retinopathy in Protocol B

Time Frame

5 years

Title

Urinary albumin/creatinine ratio in Protocol B

Time Frame

5 years

Title

Urinary protein/creatinine ratio in Protocol B

Time Frame

5 years

10. Eligibility

Sex

All

Minimum Age & Unit of Time

20 Years

Maximum Age & Unit of Time

75 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Hirofumi Makino, M.D.

Organizational Affiliation

Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences

Official's Role

Principal Investigator

Facility Information:

Facility Name

Okayama University Hospital

City

Okayama

ZIP/Postal Code

700-8558

Country

Japan

12. IPD Sharing Statement

Learn more about this trial

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

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