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

Email

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


Email

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


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

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


Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name