UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | C000000370 |
|---|---|
| Receipt number | 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 10:41:53 |
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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
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/
tsaito@fukuoka-u.ac.jp
Sponsor or person
Institute
Japanese Society of Kidney and Lipids
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000466
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