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Recruitment status
Unique ID issued by UMIN C000000280
Receipt No. R000000357
Scientific Title Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Date of disclosure of the study information 2005/11/16
Last modified on 2016/06/09

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Basic information
Public title Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Acronym Study for the effectiveness of intensive therapy aiming at a remission of diabetic nephropathy (DNETT-Japan)
Scientific Title Study for the effectiveness of intensive therapy for diabetic nephropathy in unblinded, randomized intergroup comparison study.
Scientific Title:Acronym 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

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

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
1st name
Middle name
Last name Hirofumi Makino
Organization Okayama University, Graduate School of Medicine, Dentistry and Pharmaceutical Sciences
Division name Department of Kidney, Immunity, Endocrinology and Metabolism
Zip code
Address 2-5-1, Shikada-cho, Okayama City, Okayama, 700-8558
TEL 086-235-7232
Email

Public contact
Name of contact person
1st name
Middle name
Last name Kenichi Shikata
Organization Okayama University Hospital
Division name Department of Kidney, Immunity, Endocrinology and Metabolism
Zip code
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

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)

IRB Contact (For public release)
Organization
Address
Tel
Email

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

Related information
URL releasing protocol
Publication of results Unpublished

Result
URL related to results and publications
Number of participants that the trial has enrolled
Results
Results date posted
Results Delayed
Results Delay Reason
Date of the first journal publication of results
Baseline Characteristics
Participant flow
Adverse events
Outcome measures
Plan to share IPD
IPD sharing Plan description

Progress
Recruitment status
Date of protocol fixation
2005 Year 05 Month 31 Day
Date of IRB
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

Other
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/ctr_e/ctr_view.cgi?recptno=R000000357

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


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