UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000002975 |
|---|---|
| Receipt number | R000003499 |
| Scientific Title | Comparative clinical study of de novo kidney transplantation-GRACEPTOR vs PROGRAF-multi center study |
| Date of disclosure of the study information | 2010/01/07 |
| Last modified on | 2010/01/05 13:58:34 |
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Basic information
Public title
Comparative clinical study of de novo kidney transplantation-GRACEPTOR vs PROGRAF-multi center study
Acronym
Comparative clinical study of de novo kidney transplantation-GRACEPTOR vs PROGRAF-
Scientific Title
Comparative clinical study of de novo kidney transplantation-GRACEPTOR vs PROGRAF-multi center study
Scientific Title:Acronym
Comparative clinical study of de novo kidney transplantation-GRACEPTOR vs PROGRAF-
Region
| Japan |
Condition
Condition
Chronic renal failure
Classification by specialty
| Nephrology | Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
Estimation of efficacy and safety of GRACEPTOR
Basic objectives2
Safety
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
Pharmacokinetics
Key secondary outcomes
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Active
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
2
Purpose of intervention
Treatment
Type of intervention
| Medicine |
Interventions/Control_1
GRACEPTOR
Interventions/Control_2
PROGRAF
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
| 16 | years-old | <= |
Age-upper limit
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
de novo kidney transplantation
living kidney transplantation
Key exclusion criteria
previous history of organ transplantation
women during pregnancy
Target sample size
100
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Kazunari Tanabe |
Organization
Tokyo Women's Medical University
Division name
Urology
Zip code
Address
8-1 Kawada-cho,Shinjuku-ku,Tokyo,Japan
TEL
03-3353-8111
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name |
Organization
Tokyo Women's Medical University
Division name
Urology
Zip code
Address
TEL
Homepage URL
Sponsor or person
Institute
Department of Urology,
Tokyo Women's Medical University
Institute
Department
Personal name
Funding Source
Organization
Department of Urology,
Tokyo Women's Medical University
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
東京女子医科大学 腎臓病総合医療センター 泌尿器科（東京都）
東光会 戸田中央総合病院（埼玉県）
東京都保健医療公社 大久保病院（東京都）
Other administrative information
Date of disclosure of the study information
| 2010 | Year | 01 | Month | 07 | 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
Enrolling by invitation
Date of protocol fixation
| 2009 | Year | 10 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 10 | Month | 01 | Day |
Last follow-up date
| 2016 | Year | 09 | Month | 01 | Day |
Date of closure to data entry
| 2016 | Year | 12 | Month | 01 | Day |
Date trial data considered complete
| 2017 | Year | 03 | Month | 01 | Day |
Date analysis concluded
| 2017 | Year | 03 | Month | 01 | Day |
Other
Other related information
Management information
Registered date
| 2010 | Year | 01 | Month | 05 | Day |
Last modified on
| 2010 | Year | 01 | Month | 05 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003499
