UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000007371 |
|---|---|
| Receipt number | R000008666 |
| Scientific Title | Prospective evaluation of renal function and proteinuria in chronic kidney disease patients |
| Date of disclosure of the study information | 2012/02/24 |
| Last modified on | 2015/09/03 10:13:55 |
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Basic information
Public title
Prospective evaluation of renal function
and proteinuria in chronic kidney disease
patients
Acronym
Prospective evaluation of renal function
and proteinuria in chronic kidney disease
patients (PERFECT study)
Scientific Title
Prospective evaluation of renal function
and proteinuria in chronic kidney disease
patients
Scientific Title:Acronym
Prospective evaluation of renal function
and proteinuria in chronic kidney disease
patients (PERFECT study)
Region
| Japan |
Condition
Condition
Proteinuria
Classification by specialty
| Medicine in general | Cardiology | Nephrology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
To evaluate the influence which Strong statin has on a renal function to the patient judged that the aggressive lipid fall treatment are required with proteinuria in a single center prospective randomized trial.
Basic objectives2
Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Change of the protein in urine / creatinine ratio after 52 weeks
Key secondary outcomes
Change of the protein in urine / creatinine ratio after 26 weeks
Change of the albumin in urine / creatinine ratio
after 26 weeks and 52 weeks
Lipid rate of change
after 26 weeks and 52 weeks
Change of eGFR
after 26 weeks and 52 weeks
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
Institution consideration
Blocking
Concealment
Numbered container method
Intervention
No. of arms
3
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
Atorvastatin High capacity group
Interventions/Control_2
Atorvastatin normal capacity group
Interventions/Control_3
Rosuvastatin group
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
| Not applicable |
Gender
Male and Female
Key inclusion criteria
the protein in urine / creatinine ratio
above 150mg.
Three-month or more administration of the angiotensin converting enzyme inhibitor or angiotensin 2 receptor inhibitor.
the patient judged that the aggressive lipid fall treatment are required.
Key exclusion criteria
The patient who caused acute coronary syndrome within six months.
The patient of an inflammatory disorder, infection, and a malignant tumor.
The patient who has an anamnesis of hypersensitivity to atorvastatin
and/or rosuvastatin.
A pregnant woman or the woman that may have become pregnant, and a nursing mother.
A patient with critical impaired liver function and renal dysfunction.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Masato Watarai |
Organization
Aichi welfare agricultural cooperative association
Anjo Kosei Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
28, Higashihirokute, Anjo-cho, Anjo-shi, Aichi-ken
TEL
0566-75-2111
masachi_110@med.nagoya-u.ac.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Masanori Ito |
Organization
Aichi welfare agricultural cooperative association Anjo Kosei Hospital
Division name
Division of Cardiology, Department of Internal Medicine
Zip code
Address
28, Higashihirokute, Anjo-cho, Anjo-shi, Aichi-ken
TEL
0566-75-2111
Homepage URL
masachi_110@med.nagoya-u.ac.jp
Sponsor or person
Institute
Aichi welfare agricultural cooperative association
Anjo Kosei Hospital
Institute
Department
Personal name
Funding Source
Organization
Aichi welfare agricultural cooperative association
Anjo Kosei Hospital
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
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
| 2012 | Year | 02 | Month | 24 | 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
| 2012 | Year | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 02 | Month | 01 | Day |
Last follow-up date
| 2013 | Year | 12 | Month | 01 | Day |
Date of closure to data entry
| 2013 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2013 | Year | 12 | Month | 01 | Day |
Date analysis concluded
| 2014 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2012 | Year | 02 | Month | 24 | Day |
Last modified on
| 2015 | Year | 09 | Month | 03 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008666
