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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN C000000370
Receipt No. R000000466
Scientific Title Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study)
Date of disclosure of the study information 2006/03/27
Last modified on 2009/11/06

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Basic information
Public title Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study)
Acronym Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor in type 2 diabetic nephropathy (MIDN Study)
Scientific Title Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study)
Scientific Title:Acronym Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor in type 2 diabetic nephropathy (MIDN Study)
Region
Japan

Condition
Condition Type 2 diabetic nephropathy with hyperlipidemia
Classification by specialty
Medicine in general Cardiology Endocrinology and Metabolism
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 The blood pressure of patients with type 2 diabetic nephropathy has been stable for more than 3 months by antihypertensive agents including an angiotensin II receptor blocker. In this condition, we divide the subjects into an intensive therapy group with simvastatin and a standard therapy group. We make the different target of LDL-C level in each group and compare the preventive effects against renal lesions.
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes urine albumin/creatinine ratio and its reduction rate.
urine protein/creatinine ratio and its reduction rate.
Key secondary outcomes creatinine clearance (Ccr).
reciprocal of serum creatinine (1/Scr).
HOMA-IR.
urine protein, albumin and type IV collagen.
serum total cholesterol, LDL-cholesterol, HDL-cholesterol, triglycerides, cystatin C, glucose and insulin.

Base
Study type Interventional

Study design
Basic design Parallel
Randomization Randomized
Randomization unit
Blinding Open -no one is blinded
Control Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 2
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Treated with simvastatin at 10 to 20mg/day per os for 1 year. An achieved LDL cholesterol level is 100mg/dL.
Interventions/Control_2 Treated with dietary intervention and antihyperlipidemic agents except HMG-CoA reductase inhibitors. An achieved LDL cholesterol level is 120mg/dL.
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
30 years-old <=
Age-upper limit
75 years-old >=
Gender Male and Female
Key inclusion criteria 1) The subject has not needed to be treated with insulin during 6 months after the diagnosis of type 2 diabetes mellitus.
2) The subject is hyperlipidemic with more than 200mg/dL of serum total cholesterol or more than 120mg/dL of serum LDL cholesterol.
3) The subject's urine protein/creatinine ratio is between 300 and 3500mg/gCr.
4) The subject's blood pressure has been controlled in less than 140/90mmHg for more than 3months.
5) The subject has voluntarily signed a document of the informed consent.
Key exclusion criteria 1) Type 1 diabetes mellitus.
2) The subject has cardio-vascular complications as follows:
receiving coronary artery bypass grafting (CABG) or percutaneous transluminal coronary angioplasty (PTCA) within 3 months; unstable angina; myocardial infarction; transient ischemic attack (TIA) within 6 months, congestive heart failure classified into class III or IV of New York Heart Association (NYHA); cerebral infarction within 3months.
3) The subject has non diabetic nephropathy such as chronic glomerulonephritis, nephrotic syndrome and polycystic kidney.
4) The subject's serum creatinine is more than 2.5mg/dL.
5) The subject has secondary hypertension except that due to diabetes.
6) The subject's HbA1c is more than 9%.
7) The subject is inappropriate for participation in the study for other reasons, as determined by an investigator.
Target sample size 200

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Takao Saito
Organization Fukuoka University School of Medicine
Division name Division of Nephrology and Rheumatology, Department of Internal Medicine
Zip code
Address 7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
TEL
Email

Public contact
Name of contact person
1st name
Middle name
Last name Takao Saito
Organization Japanese Society of Kidney and Lipids
Division name Division of Nephrology and Rheumatology, Fukuoka University Hospital
Zip code
Address
TEL 092-801-1011ext.3374
Homepage URL http://www.evidence.jp/midn/
Email tsaito@fukuoka-u.ac.jp

Sponsor
Institute Japanese Society of Kidney and Lipids
Institute
Department

Funding Source
Organization Japan Kidney Foundation
Organization
Division
Category of Funding Organization Non profit foundation
Nationality of Funding Organization

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

IRB Contact (For public release)
Organization
Address
Tel
Email

Secondary IDs
Secondary IDs NO
Study ID_1
Org. issuing International ID_1
Study ID_2
Org. issuing International ID_2
IND to MHLW

Institutions
Institutions

Other administrative information
Date of disclosure of the study information
2006 Year 03 Month 27 Day

Related information
URL releasing protocol
Publication of results Published

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 Completed
Date of protocol fixation
2004 Year 03 Month 13 Day
Date of IRB
Anticipated trial start date
2004 Year 07 Month 01 Day
Last follow-up date
2007 Year 12 Month 01 Day
Date of closure to data entry
2008 Year 04 Month 01 Day
Date trial data considered complete
2008 Year 04 Month 01 Day
Date analysis concluded
2009 Year 03 Month 01 Day

Other
Other related information

Management information
Registered date
2006 Year 03 Month 25 Day
Last modified on
2009 Year 11 Month 06 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000466

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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