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Name:
UMIN ID:

Recruitment status No longer recruiting
Unique ID issued by UMIN UMIN000006600
Receipt No. R000007791
Scientific Title Effect of statin for CKD with hyperlipidemia
Date of disclosure of the study information 2011/11/01
Last modified on 2016/04/24

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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
Middle name
Last name Kunihiro Yamagata
Organization Univ. of Tsukuba
Division name Nephrology
Zip code
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
Middle name
Last name Chie Saito
Organization University of Tsukuba
Division name Nephrology
Zip code
Address 1-1-1Tennodai, Tsukuba, Ibaraki, Japan
TEL 029-853-3202
Homepage URL
Email chie.saito@md.tsukuba.ac.jp

Sponsor
Institute Dept. of Nephrology, Univ. of Tsukuka
Institute
Department

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
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 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
2016 Year 04 Month 24 Day


Link to view the page
URL(English) https://upload.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


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