UMIN-CTR Clinical Trial

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
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	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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/icdr_e/ctr_view.cgi?recptno=R000007791