Unique ID issued by UMIN | UMIN000001324 |
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Receipt number | R000001595 |
Scientific Title | Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY |
Date of disclosure of the study information | 2008/08/22 |
Last modified on | 2008/08/20 10:39:38 |
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Japan |
Type 2 diabetic nephropathy with Hypercholesterolemia
Medicine in general | Endocrinology and Metabolism | Nephrology |
Others
NO
To conduct a randomized controlled trial to compare the effects of 12 months' treatment with pitavastatin and pravastatin in type 2 diabetes patients with diabetic nephropathy and hypercholesterolemia
Safety
Changes in urinary albumin/creatinine ratio,Changes in eGFR
urinary albumin/creatinine ratio, serum creatinine , Urea nitrogen, serum cystein C, LDL-C,TC,TG,HDL-C,non HDL-C, 8-isoprostane, urinary L-FABP, urinary typeIV collagen
Interventional
Parallel
Randomized
Individual
Open -no one is blinded
Active
NO
YES
Institution is not considered as adjustment factor.
NO
Central registration
2
Treatment
Medicine |
Pitavastatin treatment group
Pravastatin treatment group
20 | years-old | <= |
Not applicable |
Male and Female
1.Type 2 diabetes patients with diabetic nephropathy and hypercholesterolemia fulfilling one or more of the following criteria
1) Biopsy-proven diabetic nephropathy
2) Duration of diabetes more than 5 years
3) Diabetic retinopathy
2.At least on two occasions during the observation period (0 month excluded), urinary albumin/ creatinine ratio in the range of 30-600mg/g.
3.Hypercholesterolemia
4.Over 20 years of age
5.Outpatient
1."Contraindications""Relative Contraindications""Absolute Contraindications for Coadministration" and "Relative Contraindications for Coadministration" for pitavastatin or pravastatin
2.Patients with hypothyroidism or inherited muscle disorder (muscular dystrophy etc.) and
patients with a previous history of drug-induced myopathy
3.Non- diabetic nephropathy
4. Renal dysfunction (s-Cr over 1.5 mg/dl)
5.Urinary tract infection
6.Uncontrolled diabetes, defined as HbA1c>10.0%
7.Malignancy
8. Stroke
9. Heart failure (NYHA Class >= III) or myocardial infarction
10.Angina with symptom
11.Participating in clinical trials or clinical research
12.Judged as unsuitable for participating in this study by the attending physician
100
1st name | |
Middle name | |
Last name | Ryouichi Takayanagi |
Kyushu University Graduate School of Medical Sciences
Department of Medicine and Bioregulatory Science
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
092-642-5284
1st name | |
Middle name | |
Last name | Toyoshi Inoguchi |
Kyushu University Graduate School of Medical Science
Department of Medicine and Bioregulatory Science
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
092-642-5284
toyoshi@intmed3.med.kyushu-u.ac.jp
Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science
none
Self funding
NO
2008 | Year | 08 | Month | 22 | Day |
Unpublished
2008 | Year | 07 | Month | 12 | Day |
2008 | Year | 08 | Month | 01 | Day |
2010 | Year | 01 | Month | 01 | Day |
2008 | Year | 08 | Month | 20 | Day |
2008 | Year | 08 | Month | 20 | Day |
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001595
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