UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000033089 |
|---|---|
| Receipt number | R000037720 |
| Scientific Title | Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring |
| Date of disclosure of the study information | 2018/06/30 |
| Last modified on | 2018/06/21 19:39:37 |
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Basic information
Public title
Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring
Acronym
Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression
Scientific Title
Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring
Scientific Title:Acronym
Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression
Region
| Japan |
Condition
Condition
End Stage Renal Disease patients to whom kidney transplantation is planned
Classification by specialty
| Nephrology | Surgery in general | Urology |
| Adult |
Classification by malignancy
Others
Genomic information
NO
Objectives
Narrative objectives1
In October 2008, Tacrolimus extended-release formulation (trade name Graceptor) was released domestically. Graceptor contain the same active immunosuppresant as conventional tacrolimus formulation (trade name Prograf). By making it a extended release formulation, it is possible to improve adherence and reduce side effects due to a change in its pharmacokinetics.
On the other hand, the dosage of the immunosuppressive agent, in general, has a narrow therapeutical window between the effective and the toxic concentration. Because significant difference in the inter-individual variation of its pharmacokinetics, it has been considered desirable to adjust the dose based on strict therapeutic drug monitoring(TDM).
However, the optimal dosage based on TDM has not been established for tacrolimus extendes release formulations.
Therefore, this study is conducted for the purpose of examining the optimal exposure using PK monitoring in tacrolimus extended-release formulation with mycophenolate mofetil combination for adult renal transplant patients.
Basic objectives2
Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Confirmatory
Trial characteristics_2
Explanatory
Developmental phase
Phase III
Assessment
Primary outcomes
Biopsy-proven acute allograft rejection rate after 6 months and 12 months.
Key secondary outcomes
1) Patient survival rate, Allograft survival rate
2) Incidence of viral infection
3)Incidence rate of de novo donor specific antibody production.
Base
Study type
Interventional
Study design
Basic design
Parallel
Randomization
Randomized
Randomization unit
Individual
Blinding
Open -no one is blinded
Control
Dose comparison
Stratification
NO
Dynamic allocation
NO
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
Standard group
Target tacrolimus AUC 0-24 hr
1) til 1 month after transplant
250ng x hr/ml
2) 1 month - 3 months after transplant
200-250 ng x hr/ml
3) 3 months thereafter transplant
200 ng x hr/ml
Interventions/Control_2
Low dose group
Target tacrolimus AUC 0-24 hr
1) til 1 month after transplant
200ng x hr/ml
2) 1 month - 3 months after transplant
150-200 ng x hr/ml
3) 3 months thereafter transplant
150 ng x hr/ml
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
| 65 | years-old | >= |
Gender
Male and Female
Key inclusion criteria
1) ABO compatible or mismatch kideny transplant recipient.
2) de novo kidney transplant recipient from non-HLA identical living renal donor.
3) Recipient who can be resposible for the written consents.
4) Women who is no pregnent.
Key exclusion criteria
1) Multiple organ recipient or previous transplant history.
2) HLA identical living related donor.
3) ABO incompatible or T cell CDC-crossmatch positive case.
4) HIV, HCV, HBsAb positive recipients.
Target sample size
60
Research contact person
Name of lead principal investigator
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Watarai |
Organization
Nagoya Daini Red Cross Hospital
Kidney Disease Center
Division name
Transplant Surgery
Zip code
Address
2-9 Myoken cho, Syowa ku, Nagoya, Japan 4668650
TEL
052-832-1121
watarai@nagoya2.jrc.or.jp
Public contact
Name of contact person
| 1st name | |
| Middle name | |
| Last name | Yoshihiko Watarai |
Organization
Nagoya Daini Red Cross Hospital
Division name
Transplant Surgery
Zip code
Address
2-9 Myoken cho, Syowa ku, Nagoya, Japan 4668650
TEL
052-832-1121
Homepage URL
watarai@nagoya2.jrc.or.jp
Sponsor or person
Institute
Department of Transplant Surgery
Kidney Disease Center
Nagoya Daini Red Cross Hospital
Institute
Department
Personal name
Funding Source
Organization
Department of Transplant Surgery
Kidney Disease Center
Nagoya Daini Red Cross Hospital
Organization
Division
Category of Funding Organization
Self funding
Nationality of Funding Organization
Other related organizations
Co-sponsor
Kumamoto Red Cross Hospital
Name of secondary funder(s)
Department of Surgery
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
名古屋第二赤十字病院、熊本赤十字病院
Other administrative information
Date of disclosure of the study information
| 2018 | Year | 06 | Month | 30 | 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 | 07 | Month | 06 | Day |
Date of IRB
Anticipated trial start date
| 2012 | Year | 09 | Month | 01 | Day |
Last follow-up date
| 2019 | Year | 08 | Month | 31 | Day |
Date of closure to data entry
| 2020 | Year | 03 | Month | 31 | Day |
Date trial data considered complete
| 2020 | Year | 04 | Month | 01 | Day |
Date analysis concluded
Other
Other related information
Management information
Registered date
| 2018 | Year | 06 | Month | 21 | Day |
Last modified on
| 2018 | Year | 06 | Month | 21 | Day |
Link to view the page
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037720
