UMIN-CTR Clinical Trial

Basic information
Public title	Efficacy and safety of everolimus (Certican) plus once-daily prolonged-release tacrolimus (Graceptor) combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Acronym	Efficacy and safety of everolimus plus once-daily prolonged-release tacrolimus combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Scientific Title	Efficacy and safety of everolimus (Certican) plus once-daily prolonged-release tacrolimus (Graceptor) combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Scientific Title:Acronym	Efficacy and safety of everolimus plus once-daily prolonged-release tacrolimus combination therapy in living donor kidney transplantation: Open-label, multicenter, randomized controlled trial.
Region	Japan

Condition
Condition	Kidney transplantation
Classification by specialty	Urology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	Aim of this multicenter, randomized controlled trial is to compare the efficacy and safety of once-daily prolonged-release tacrolimus plus everolimus to once-daily prolonged-release tacrolimus plus mycophenolate mofetil immunosuppressive regimen in cytomegalovirus high-risk transplant recipients.
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1
Trial characteristics_2
Developmental phase

Assessment
Primary outcomes	Rejection Graft survival, patient survival CMV infection
Key secondary outcomes	Incidence of adverse effects/abnormalities in the laboratory values. Kidney function(eGFR) Anti-HLA antibodies Chronic allograft nephropathy BKV infection

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
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	everolimus
Interventions/Control_2	mycophenolate mofetil
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	Not applicable
Gender	Male and Female
Key inclusion criteria	1. Subject over 20 years old. 2.Living donor kidney transplantation 3.CMV-seropositive recipient/seropositive donor 4. Patients who had a detailed briefing of the trial with explanatory documents prior to the enrollment, and voluntarily signed a consent form.
Key exclusion criteria	1. Inability or un willingness to sign a consent form. 2. Subject under 20 years old. 3.ABO blood incompatible kidney transplantation 4.Unable to outpatient treatment in study period 5.Pregnancy or possible to pregnant 6.Serious digestive disease 7.Active infectious disease 8. Cancer 9. Hypersensibility to sirolimus or everolimus 10. Investigator considered inappropriate as a subject of this study.
Target sample size	120

Research contact person
Name of lead principal investigator	1st name Middle name Last name Kazunari Tanabe
Organization	Tokyo Women's Medical University
Division name	Dep. Urology
Zip code
Address	8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
TEL	0333538111
Email	tanabe@kc.twmu.ac.jp

Public contact
Name of contact person	1st name Middle name Last name Hideki Ishida
Organization	Tokyo Women's Medical University
Division name	Dep. Urology
Zip code
Address	8-1, Kawadacho, Sinzyuku-ku, Tokyo, Japan
TEL	03-3353-8111
Homepage URL
Email	tgphide@gol.com

Sponsor
Institute	Tokyo Women's Medical University, Dep. Urology
Institute
Department

Funding Source
Organization	none
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
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

Other administrative information
Date of disclosure of the study information	2013 Year 10 Month 01 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	Open public recruiting
Date of protocol fixation	2013 Year 08 Month 01 Day
Date of IRB
Anticipated trial start date	2013 Year 10 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

Management information
Registered date	2013 Year 08 Month 23 Day
Last modified on	2013 Year 08 Month 23 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000013526

Research Plan
Registered date	File name

Research case data specifications
Registered date	File name

Research case data
Registered date	File name

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