UMIN-CTR Clinical Trial

Unique ID issued by UMIN UMIN000006600
Receipt number R000007791
Scientific Title Effect of statin for CKD with hyperlipidemia
Date of disclosure of the study information 2011/11/01
Last modified on 2019/10/30 14:42:10

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Basic information

Public title

Effect of statin for CKD with hyperlipidemia

Acronym

Ibaraki Pitavastatin or rosuvastatin renal function improvement trial: i-PLUM

Scientific Title

Effect of statin for CKD with hyperlipidemia

Scientific Title:Acronym

Ibaraki Pitavastatin or rosuvastatin renal function improvement trial: i-PLUM

Region

Japan


Condition

Condition

chronic kidney disease

Classification by specialty

Medicine in general Nephrology

Classification by malignancy

Others

Genomic information

NO


Objectives

Narrative objectives1

To compare reno-protective effect of pitavastatin and rosuvastatin in chronic kidney disease patients with dyslipidemia peforming nutrition couceling

Basic objectives2

Safety,Efficacy

Basic objectives -Others


Trial characteristics_1

Exploratory

Trial characteristics_2

Pragmatic

Developmental phase

Phase IV


Assessment

Primary outcomes

Percent change of estimated GFR

Key secondary outcomes

1. Changes of plasma and urine parameters related to renal function and dyslipidemia (T-Chol, TG, HDL-C, LDL-C, UN, Cr, TP, Alb, hs-CRP, cystatin C, HbA1C, AST, ALT, gamma-GTP, CK, urinary protein, urine protein creatinine ratio)
2. Adverse reactions


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

Treat with pitavastatin (2mg daily) for 52 weeks

Interventions/Control_2

Treat with rosuvastatin (2.5mg daily) for 52 weeks

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

eGFR < 60mL/min/1.73m2

Patient for doing nourishment instruction with CKD guideline more than one month,
TC>180mg/dL or LDL-C>100mg/dL after diet therapy

Key exclusion criteria

1. Patient taking HMG-CoA reductase inhibitors
2. Patient taking cyclosporin.
3. Patient taking glucocorticoid
4. eGFR<15, or liver dysfunction
5. Patient with nephrotic syndrome
6. Patients with malignacy
7. Pregnant or nursing woman
8. Familial hypercholesteremia
9. LDL-C>200mg/dL
10. Patient who donot give written informed consent
11.Patient with diagnosis inadequacy for doctor in attendance

Target sample size

100


Research contact person

Name of lead principal investigator

1st name Kunihiro
Middle name
Last name Yamagata

Organization

Univ. of Tsukuba

Division name

Nephrology

Zip code

305-8575

Address

1-1-1 Tennodai, Tsukuba, Ibaraki 305-8575

TEL

029-853-3202

Email

k-yamaga@md.tsukuba.ac.jp


Public contact

Name of contact person

1st name Chie
Middle name
Last name Saito

Organization

University of Tsukuba

Division name

Nephrology

Zip code

305-8575

Address

1-1-1Tennodai, Tsukuba, Ibaraki, Japan

TEL

029-853-3202

Homepage URL


Email

chie.saito@md.tsukuba.ac.jp


Sponsor or person

Institute

Dept. of Nephrology, Univ. of Tsukuka

Institute

Department

Personal name



Funding Source

Organization

Department of Nephrology, University of Tsukuba

Organization

Division

Category of Funding Organization

Self funding

Nationality of Funding Organization

Japan


Other related organizations

Co-sponsor

None

Name of secondary funder(s)



IRB Contact (For public release)

Organization

University of Tsukuba Hospital

Address

1-1-1 Tennodai, Tsukuba, Ibaraki, Japan

Tel

029-853-3914

Email

rinshokenkyu@un.tsukuba.ac.jp


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

筑波大学附属病院(茨城県)、茨城西南医療センター病院(茨城県)、牛久愛和総合病院(茨城県)、県西総合病院(茨城県)、聖隷佐倉市民病院(千葉県)、竹村内科腎クリニック(栃木県)、筑波記念病院(茨城県)、 筑波学園病院(茨城県)、つくばセントラル病院(茨城県)、筑波メディカルセンター病院(茨城県)、東京医科大学茨城医療センター(茨城県)、なめがた地域総合病院(茨城県)、日立製作所日立総合病院(茨城県)、水戸協同病院(茨城県)、水戸済生会総合病院(茨城県)


Other administrative information

Date of disclosure of the study information

2011 Year 11 Month 01 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

No longer recruiting

Date of protocol fixation

2011 Year 10 Month 20 Day

Date of IRB


Anticipated trial start date

2011 Year 11 Month 01 Day

Last follow-up date

2014 Year 12 Month 31 Day

Date of closure to data entry

2015 Year 03 Month 01 Day

Date trial data considered complete

2015 Year 06 Month 01 Day

Date analysis concluded

2015 Year 12 Month 01 Day


Other

Other related information



Management information

Registered date

2011 Year 10 Month 24 Day

Last modified on

2019 Year 10 Month 30 Day



Link to view the page

Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000007791


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name