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Main
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Note: This record shows only 22 elements of the WHO Trial Registration Data Set. To view changes that have been made to the source record, or for additional information about this trial, click on the URL below to go to the source record in the primary register. |
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Register:
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JPRN |
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Last refreshed on:
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17 October 2023 |
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Main ID: |
JPRN-C000000370 |
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Date of registration:
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27/03/2006 |
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Prospective Registration:
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No |
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Primary sponsor: |
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Public title:
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Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study)
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Scientific title:
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Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor (simvastatin) in type 2 diabetic nephropathy with hyperlipidemia (MIDN Study) - Multicenter study for the effect preserving renal function of HMG-CoA reductase inhibitor in type 2 diabetic nephropathy (MIDN Study) |
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Date of first enrolment:
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2004/07/01 |
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Target sample size:
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200 |
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Recruitment status: |
Complete: follow-up complete |
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URL:
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https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000000466 |
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Study type:
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Interventional |
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Study design:
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Parallel Randomized
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Phase:
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Not selected
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Countries of recruitment
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Japan
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Contacts
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Name:
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Takao Saito |
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Address:
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Japan |
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Telephone:
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092-801-1011ext.3374 |
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Email:
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tsaito@fukuoka-u.ac.jp |
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Affiliation:
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Japanese Society of Kidney and Lipids Division of Nephrology and Rheumatology, Fukuoka University Hospital |
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Name:
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Takao Saito |
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Address:
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7-45-1 Nanakuma, Jonan-ku, Fukuoka 814-0180, Japan
Japan |
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Telephone:
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Email:
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Affiliation:
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Fukuoka University School of Medicine Division of Nephrology and Rheumatology, Department of Internal Medicine |
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Key inclusion & exclusion criteria
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Inclusion criteria:
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.
Age minimum:
30years-old
Age maximum:
75years-old
Gender:
Male and Female
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Health Condition(s) or Problem(s) studied
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Type 2 diabetic nephropathy with hyperlipidemia
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Intervention(s)
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Treated with simvastatin at 10 to 20mg/day per os for 1 year. An achieved LDL cholesterol level is 100mg/dL.
Treated with dietary intervention and antihyperlipidemic agents except HMG-CoA reductase inhibitors. An achieved LDL cholesterol level is 120mg/dL.
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Primary Outcome(s)
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urine albumin/creatinine ratio and its reduction rate. urine protein/creatinine ratio and its reduction rate.
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Secondary Outcome(s)
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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.
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Source(s) of Monetary Support
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Japan Kidney Foundation
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Ethics review
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Status: YES
Approval date:
Contact:
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Results
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Results available:
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Yes |
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Date Posted:
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Date Completed:
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01/12/2007 |
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URL:
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