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
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
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
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
