UMIN-CTR Clinical Trial

Basic information
Official scientific title of the study	Optimization of Extended-Release Tacrolimus Dose with Mycophenolate Mofetil based Immunosuppression in De novo Kidney Transplant Recipients using extensive pharmacokinetics monitoring
Title of the study (Brief title)	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	Yoshihiko Watarai
Organization	Nagoya Daini Red Cross Hospital Kidney Disease Center
Division name	Transplant Surgery
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	Yoshihiko Watarai
Organization	Nagoya Daini Red Cross Hospital
Division name	Transplant Surgery
Address	2-9 Myoken cho, Syowa ku, Nagoya, Japan 4668650
TEL	052-832-1121
Homepage URL
Email	watarai@nagoya2.jrc.or.jp

Sponsor
Institute	Department of Transplant Surgery Kidney Disease Center Nagoya Daini Red Cross Hospital
Institute
Department

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

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

Progress
Recruitment status	Completed
Date of protocol fixation	2012 Year 07 Month 06 Day
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

Related information
URL releasing protocol
Publication of results	Unpublished
URL releasing results
Results
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
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000037720