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UMIN ID:

Recruitment status Open public recruiting
Unique ID issued by UMIN UMIN000011562
Receipt No. R000013526
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.
Date of disclosure of the study information 2013/10/01
Last modified on 2013/08/23

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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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