UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001324 |
|---|---|
| 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 |
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Basic information
Public title
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Acronym
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Scientific Title
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Scientific Title:Acronym
Kyushu pitavastatin and pravastatin Intervention trial on Diabetic NEphropathY
Region
| Japan |
Condition
Condition
Type 2 diabetic nephropathy with Hypercholesterolemia
Classification by specialty
| Medicine in general | Endocrinology and Metabolism | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
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
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Changes in urinary albumin/creatinine ratio,Changes in eGFR
Key secondary outcomes
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
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
YES
Institution consideration
Institution is not considered as adjustment factor.
Blocking
NO
Concealment
Central registration
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Pitavastatin treatment group
Interventions/Control_2
Pravastatin treatment group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
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
Key exclusion criteria
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
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Ryouichi Takayanagi |
Organization
Kyushu University Graduate School of Medical Sciences
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5284
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Toyoshi Inoguchi |
Organization
Kyushu University Graduate School of Medical Science
Division name
Department of Medicine and Bioregulatory Science
Zip code
Address
3-1-1Maidashi, Higashi-ku, Fukuoka-shi, Fukuoka 812-8582, Japan
TEL
092-642-5284
Homepage URL
toyoshi@intmed3.med.kyushu-u.ac.jp
Sponsor or person
Institute
Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Self funding
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
| 2008 | Year | 08 | Month | 22 | 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
| 2008 | Year | 07 | Month | 12 | Day |
Date of IRB
Anticipated trial start date
| 2008 | Year | 08 | Month | 01 | Day |
Last follow-up date
| 2010 | Year | 01 | Month | 01 | Day |
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2008 | Year | 08 | Month | 20 | Day |
Last modified on
| 2008 | Year | 08 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001595
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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| Registered date | File name |
