UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000002526
Receipt No. 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

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


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
Email 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
Email tamukou@med.yokohama-cu.ac.jp

Sponsor
Institute Department of Medical Science and Cardiorenal Medicine
Institute
Department

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
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 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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003086

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.