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Name:
UMIN ID:

Recruitment status Completed
Unique ID issued by UMIN UMIN000007371
Receipt No. 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

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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
Email 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
Email masachi_110@med.nagoya-u.ac.jp

Sponsor
Institute Aichi welfare agricultural cooperative association
Anjo Kosei Hospital
Institute
Department

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
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

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
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000008666

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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