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Recruitment status
Unique ID issued by UMIN UMIN000001324
Receipt No. 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

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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
Email

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
Email toyoshi@intmed3.med.kyushu-u.ac.jp

Sponsor
Institute Kyushu University Graduate School of Medical Science Department of Medicine and Bioregulatory Science
Institute
Department

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
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
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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001595

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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