UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Title of the study (Brief title)	Study for the effectiveness of intensive therapy aiming at a remission of diabetic nephropathy (DNETT-Japan)
Region	Japan

Condition
Condition	Diabetic Nephropathy
Classification by specialty	Endocrinology and Metabolism Nephrology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Protocol A: Prevention of nephropathy progression in the integrated therapy for diabetic patients with overt nephropathy (urinary albumin/creatinine ratio>=300mg/gCr, and serum creatinine level<1.2mg/dL for male; serum creatinine level<1.0mg/dL for female) randomized to the integrated therapy or the conventional therapy is examined by assessing the excretion of urinary protein as a primary outcome.Protocol B: Prevention of nephropathy progression in the integrated therapy for diabetic patients with overt nephropathy (urinary albumin/creatinine ratio >= 300mg/gCr, and 1.2mg/dL <= serum creatinine level <= 2.5mg/dL for male; 1.0mg/dL <= serum creatinine level <= 2.5mg/dL for female) randomized to the integrated therapy or the conventional therapy is examined by assessing the doubling of serum creatinine level, introduction of dialysis therapy or renal transplant, and death as primary outcomes.
Basic objectives2	Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Not applicable

Assessment
Primary outcomes	Protein/creatinine ratio in albuminuria(first urine in early-morning)
Key secondary outcomes	Protocol A:1) GFR 2) cardiovascular event 3) progression of retinopathy 4) albumin/creatinine ratio 5)albuminuria (collected for 24 hrs.) Protocol B:1)GFR 2)cardiovascular event 3)progression of retinopathy 4)albumin/creatinine ratio 5)protein/creatinine ratio

In outcomes field, the entry of just a few words such as "safety" or "efficiency" will not be accepted. Specify the name of outcome measures, including the time when you plan to measure. Usually, only one primary outcome is accepted. Write the other outcomes in "secondary outcomes" field.

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	NO
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	No need to know

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine Behavior,custom
Interventions/Control_1	Drug Therapy:1.Integrated therapy group: ACE inhibitors or ARB, HMG-CoA reductase inhibitors, multi-vitamins2. Conventional therapy group: Not limited (Continuation of conventional therapy)
Interventions/Control_2	Guidance by Diabetes Medical Instructors:1.Integrated therapy group: Patient compliance instruction, antismoking instruction, nutrition instruction2.Conventional therapy group: Not limited (Continuation of conventional therapy)
Interventions/Control_3
Interventions/Control_4
Interventions/Control_5
Interventions/Control_6
Interventions/Control_7
Interventions/Control_8
Interventions/Control_9
Interventions/Control_10

In interventions field, include the details of interventions, such as duration, amount, and frequency. If the intervention includes prescription or use of medical devices, duration is required.

Eligibility
Age-lower limit	20 years-old <=
Age-upper limit	75 years-old >=
Gender	Male and Female
Key inclusion criteria	Sujects are eligible if all of the following criteria are satisfied:1) Patients with type 2 diabetes mellitus (according to the diagnostic criteria of Japan Diabetes Society, 1999)2) Patients who show urinary albumin/creatinine ratio >= 300mg/gCr (first urine in early-morning) twice in succession through the observation period.3) Patients with serum creatinine level <2.5mg/dL through the observation period.4) Patients whose consent is obtained at age >20 years or <70 years.When the criteria 2) and 3) are not fulfilled, eligibility may be confirmed by obtaining additional samples. However, the prolongation of the observation period is limited up to 3 months.
Key exclusion criteria	Patients who fall into the following categories are not eligible:1) Patients with type 1 diabetes mellitus2) Patients with hereditary diabetes mellitus or secondary diabetes mellitus.3) Patients with non-diabetic nephropathy, e.g., glomerular nephritis, lupus nephritis.4) Patients with familial hypercholesterolemia.5) Patients with secondary hypertension.6) Patients with unstable angina pectoris, or patients who have developed myocardial infarction or cerebral hemorrhage within 6 months prior to the observation period.7) Patients with any life-threatening disease which will be the cause of death within five years such as malignant tumor.8) Patients with a history of angio edema.9) Patients under LDL-apheresis by a adsorber with dextran sulphate cellose.10) Patients with biliary obstruction or severe hepatopathy.11) Patients considered as having hypergasia of hepatic metabolism such as acute hepatitis, acute exacerbation of chronic hepatitis, cirrhosis, hepatic cancer, or jaundice.12) Patients with a history of hypersensitivity against ACE inhibitors, ARBs, or HMG-CoA reductase inhibitors.13) 0patiens, and patients who want to become pregnant during the study period.14) Other patients judged as being inappropriate for the subjects of the study by investigators.
Target sample size	600

Research contact person
Name of lead principal investigator	Hirofumi Makino
Organization	Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name	Department of Kidney, Immunity, Endocrinology and Metabolism
Address	2-5-1, Shikada-cho, Okayama City, Okayama, 700-8558
TEL	086-235-7232
Email

Public contact
Name of contact person	Kenichi Shikata
Organization	Okayama University Hospital
Division name	Department of Kidney, Immunity, Endocrinology and Metabolism
Address	2-5-1, Shikada-cho, Okayama City, Okayama, 700-8558
TEL	086-235-7235
Homepage URL
Email	shikata@md.okayama-u.ac.jp

Sponsor
Institute	Okayama University Hospital
Institute
Department

Sponsor means an organization that is responsible for plan, deployment and report of the research including funding management. It doesn't mean funding agency". Therefore, all clinical trial should have the one.

Funding Source
Organization	Health, Labor and Welfare Ministry
Organization
Division
Category of Funding Organization
Nationality of Funding Organization	Japan

Other related organizations
Co-sponsor
Name of secondary funｄer(s)

Secondary IDs
Secondary IDs	YES
Study ID_1	NCT00253786
Org. issuing International ID_1	ClinicalTrials.gov
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information	2005 Year 11 Month 16 Day

Progress
Recruitment status	Recruiting
Date of protocol fixation	2005 Year 05 Month 31 Day
Anticipated trial start date	2005 Year 07 Month 01 Day
Last follow-up date	2011 Year 06 Month 01 Day
Date of closure to data entry	2012 Year 12 Month 01 Day
Date trial data considered complete	2012 Year 12 Month 01 Day
Date analysis concluded	2013 Year 03 Month 01 Day

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
Other related information

Management information
Registered date	2005 Year 11 Month 09 Day
Last modified on	2016 Year 06 Month 09 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000000357