UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003058 |
|---|---|
| Receipt number | R000003704 |
| Scientific Title | The clinical experience with Graceptor in de novo renal transplant patients and retrospective study of pharmacokinetics |
| Date of disclosure of the study information | 2010/01/19 |
| Last modified on | 2010/01/20 12:40:15 |
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Basic information
Public title
The clinical experience with Graceptor in de novo renal transplant patients and retrospective study of pharmacokinetics
Acronym
The clinical experience with Graceptor in de novo renal transplant patients and retrospective study of pharmacokinetics
Scientific Title
The clinical experience with Graceptor in de novo renal transplant patients and retrospective study of pharmacokinetics
Scientific Title:Acronym
The clinical experience with Graceptor in de novo renal transplant patients and retrospective study of pharmacokinetics
Region
| Japan |
Condition
Condition
ESRD
Classification by specialty
| Urology |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
A once-daily tacrolimus[Graceptor®](OD TAC) which is extended release formulation offers the benefit of once-daily administration over another formulation of calcineurin inhibitors, such as standard tacrolimus which requires twice daily administration[Prograf®](PRG). A once-daily dosing regimen could potentially improve compliance. We assessed clinical profile of OD TAC in the prophylaxis of allograft rejection in de novo renal transplant patients and evaluated efficacy and safety ,too. As secondary objectives, we investigated tacrolimus pharmacokinetics(PK), the correlation between AUC0-24 and Cmin(trough) and compared the dose of tacrolimus in de novo transplant patients treated with OD TAC or PRG.
Basic objectives2
Pharmacokinetics
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase
Assessment
Primary outcomes
OD TAC is a safe and effective addition to the existing therapeutic options for de novo renal transplant, but we think that target trough levels should be readjusted. Monitoring of trough levels provides a good estimate of systemic exposure.
Key secondary outcomes
Base
Study type
Observational
Study design
Basic design
Randomization
Randomization unit
Blinding
Control
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment
Intervention
No. of arms
Purpose of intervention
Type of intervention
Interventions/Control_1
Interventions/Control_2
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
| Not applicable |
Age-upper limit
| Not applicable |
Gender
Male and Female
Key inclusion criteria
Patients with end-stage renal disease which were received a kidney transplant from a living donor at Gifu University Hospital.
Key exclusion criteria
previous history of organ transplantation
woman during pregnacy
Target sample size
30
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Shinichi Ito |
Organization
Gifu university
Division name
urology
Zip code
Address
Department of Urology, Gifu University Hospital, 1-1 Yanagido-Gifu-shi, Gifu-ken 501-1194, Japan
TEL
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Kenichiro Ishida |
Organization
gifu university
Division name
urology
Zip code
Address
Department of Urology, Gifu University Hospital, 1-1 Yanagido-Gifu-shi, Gifu-ken 501-1194, Japan
TEL
058-230-6338
Homepage URL
Sponsor or person
Institute
The Department of Urology, Graduate School of Medicine, Gifu University
Institute
Department
Personal name
Funding Source
Organization
none
Organization
Division
Category of Funding Organization
Other
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
| 2010 | Year | 01 | Month | 19 | 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 | 02 | Month | 01 | Day |
Date of IRB
Anticipated trial start date
| 2009 | Year | 02 | Month | 01 | Day |
Last follow-up date
Date of closure to data entry
Date trial data considered complete
Date analysis concluded
Other
Other related information
Mean age was 37 years, 70% males, 30% ABO incompatible. Patients survival rates and graft survival rates were 100% at 6.5 months. We observed a good correlation between Cmin and AUC0-24 (r=0.896) for OD TAC.
Management information
Registered date
| 2010 | Year | 01 | Month | 19 | Day |
Last modified on
| 2010 | Year | 01 | Month | 20 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000003704
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