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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000001600
Receipt No. R000001922
Scientific Title Effect of Pitavastatin on Amelioration for Renal Function in Patients with Chronic Kidney Disease
Date of disclosure of the study information 2009/01/20
Last modified on 2014/08/19

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Basic information
Public title Effect of Pitavastatin on Amelioration for Renal Function in Patients with Chronic Kidney Disease
Acronym effect of PitavaSTatin on Amelioration for Renal function in patients with Chronic Kidney Disease (P-STAR-CKD)
Scientific Title Effect of Pitavastatin on Amelioration for Renal Function in Patients with Chronic Kidney Disease
Scientific Title:Acronym effect of PitavaSTatin on Amelioration for Renal function in patients with Chronic Kidney Disease (P-STAR-CKD)
Region
Japan

Condition
Condition Hypercholesterolemia patients evaluated inulin clearance with chronic kidney disease (stage 3)
Classification by specialty
Nephrology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To evaluate efficiency of statin therapy against GFR by inulin clearance in hypercholesterolemia patients with chronic kidney disease, and to elucidate mechanism of statin for increasing GFR.
Basic objectives2 Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes Amount of change in inulin clearance
Key secondary outcomes 1)Comparison of a percent and amount change in inulin clearance and eGFR among baseline matched CKD stage3 patients who is under medical care in Nagoya University Hospital without statins prescription
2)A percent change in inulin clearance
3)A percent and amount of change in following factors
1.Serum lipid profile (TC, LDL-C, HDL-C, TG)
2.The laboratory parameters (AST, ALT, gamma-GTP, CK, and the other)
3.The laboratory parameters(RBC, WBC, Ht, and the other)
4.The special laboratory parameters (hs-CRP, 8-OHdG, alpha1 globulin, beta2 globulin, creatine)
5.Urinary protein (Urinary albumin)

Base
Study type Interventional

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Uncontrolled
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine
Interventions/Control_1 Pitavastatin 1 mg or 2 mg daily for a period of 6 months
Interventions/Control_2
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
80 years-old >
Gender Male and Female
Key inclusion criteria (1)Patients of CKD stage 3 in
stable* phase.
*Stable: Patients whose creatine
levels do not change more than 25% for 1 year.
(2)Hypercholesterolemia patients or patients with serum LDL-C level of 120 mg/dL or more and required a cholesterol lowering agent.
(3)Patients who are over 20 years old and less than 80 years old during observation periods.
(4)Patients who were assessed GFR by inulin clearance within 3 months.
Key exclusion criteria (1)Patients whose creatine levels change more than 25% in past 1 year.
(2)Patients who are planed to change drugs for CKD.
(3)Known hypersensitivity or history of clinically significant adverse reactions to Livalo.
(4)Patients with serious hepatopathy or biliary obstruction.
(5)Patients who are being treated with cyclosporine.
(6)Pregnant, possibly pregnant, or lactating.
(7)Patients who do not accept informed consent.
(8)Patients who are judged unsuitable for this study by the doctor in charge of that patients.
Target sample size 30

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Maruyama Shoichi
Organization Nagoya University, Graduate School of Medicine
Division name Department of Nephrology
Zip code
Address 65, TURUMAI-CHO, SHOWAKU, NAGOYA, AICHI 466-8550
TEL 052-741-2111
Email

Public contact
Name of contact person
1st name
Middle name
Last name Yasuda Yoshinari
Organization Nagoya University, Graduate School of Medicine
Division name Department of Nephrology
Zip code
Address 65, TURUMAI-CHO, SHOWAKU, NAGOYA, AICHI 466-8550
TEL 052-741-2111
Homepage URL
Email yyasuda@med.nagoya-u.ac.jp

Sponsor
Institute Nagoya University, Graduate School of Medicine
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
2009 Year 01 Month 20 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
2008 Year 11 Month 28 Day
Date of IRB
Anticipated trial start date
2009 Year 02 Month 01 Day
Last follow-up date
2011 Year 02 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 12 Month 26 Day
Last modified on
2014 Year 08 Month 19 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001922

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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