UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002526 |
|---|---|
| Receipt number | R000003086 |
| Scientific Title | Effects of Statin on Renal Function in Patients with Chronic Kidney Disease |
| Date of disclosure of the study information | 2009/09/18 |
| Last modified on | 2015/09/19 10:07:24 |
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Basic information
Public title
Effects of Statin on Renal Function in
Patients with Chronic Kidney Disease
Acronym
Effects of Statin on Renal Function in
Patients with Chronic Kidney Disease
Scientific Title
Effects of Statin on Renal Function in
Patients with Chronic Kidney Disease
Scientific Title:Acronym
Effects of Statin on Renal Function in
Patients with Chronic Kidney Disease
Region
| Japan |
Condition
Condition
Chronic kidney disease
Hypercholesterolemia
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
We examine therapeutic effects of lipid-lowering therapy by statin on renal function in CKD patients.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Pragmatic
Developmental phase
Phase IV
Assessment
Primary outcomes
Percent changes in eGFR from baseline
Urinary protein excretion (UACR)
Key secondary outcomes
1)Percent changes in TC,LDL-C,HDL-C,TG
2)Percent changes in Glucose,HbA1c,
3)Percent changes in hs-CRP
4)Percent changes in Pentosidine,L-FABP
5)Ambulatory BP monitering,PWV,ABI, central blood pressure
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
YES
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
Statin group: Pitavastatin is administrated and dosage will be We increased or decreased appropriately to reach the target LDL-C level (100mg/dl).
Interventions/Control_2
Control group: Lipid-lowering therapy is performed by using non-statin medication or strategy.
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)Chronic kidney disease patients with albuminuria (urine albumin excretion ratio, UACR >= 30 mg/g-creatinine)
2)Patient who is equal to or more than LDL-C 100mg/dL
3)Outpatients
Key exclusion criteria
1)patient with less than eGFR 15mL/min/1.73m2
2)Patients meeting the contraindications or relative contraindications for pitavastatin
3)malignant tumor patient and the patient who have an anamnesis within five years
4)patient who developed cerebrovascular disorder within one month
5)patients with hypothyroidism, hereditary muscular disorder (muscular dystrophy), and medicine-related muscle disorder
6)Patients currently taking lipid lowering therapy
7)abnormal glycemia
8)angina
9)Patients participating in other studies
10)Patients ineligible for the study determined by doctors
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
tamukou@med.yokohama-cu.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kouichi TAMURA |
Organization
Yokohama City University School of Medicine
Division name
Department of Cardiorenal Medicine
Zip code
Address
3-9 Fukuura, Kanazawa-ku, Yokohama 236-0004, JAPAN
TEL
045-787-2635
Homepage URL
tamukou@med.yokohama-cu.ac.jp
Sponsor or person
Institute
Department of Medical Science and Cardiorenal Medicine
Institute
Department
Personal name
Funding Source
Organization
Self
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Japan
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
横浜市立大学附属病院
Yokohama City Univrsity Hospital
Other administrative information
Date of disclosure of the study information
| 2009 | Year | 09 | Month | 18 | 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
Completed
Date of protocol fixation
| 2009 | Year | 08 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2014 | Year | 08 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 08 | Month | 01 | Day |
Date trial data considered complete
| 2016 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 09 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2009 | Year | 09 | Month | 18 | Day |
Last modified on
| 2015 | Year | 09 | Month | 19 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003086
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| Registered date | File name |
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| Registered date | File name |
| Research case data | |
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