UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000280 |
|---|---|
| Receipt number | 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 11:23:43 |
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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
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
shikata@md.okayama-u.ac.jp
Sponsor or person
Institute
Okayama University Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000357
