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

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 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


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

Value
https://center6.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