UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000001600 |
|---|---|
| Receipt number | 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 21:55:43 |
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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
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
yyasuda@med.nagoya-u.ac.jp
Sponsor or person
Institute
Nagoya University, Graduate School of Medicine
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
| 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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000001922
