UMIN-CTR Clinical Trial

BACK TOP
UMIN-CTR English Home Glossary (Simple) FAQ Search clinical trials

Name:
UMIN ID:

Recruitment status Enrolling by invitation
Unique ID issued by UMIN UMIN000017572
Receipt No. R000020342
Scientific Title Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Date of disclosure of the study information 2015/05/14
Last modified on 2015/05/14

* This page includes information on clinical trials registered in UMIN clinical trial registed system.
* We don't aim to advertise certain products or treatments


Basic information
Public title Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Acronym An early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Scientific Title Multi-center study about an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Scientific Title:Acronym An early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Region
Japan

Condition
Condition Kidney transplant recipients
Classification by specialty
Urology
Classification by malignancy Others
Genomic information NO

Objectives
Narrative objectives1 To investigate the efficacy and safety for an early steroid withdrawal immunosuppression in kidney transplant patients receiving everolimus
Basic objectives2 Safety,Efficacy
Basic objectives -Others
Trial characteristics_1 Confirmatory
Trial characteristics_2 Pragmatic
Developmental phase Not applicable

Assessment
Primary outcomes The incidence rate of acute rejection, The rate of kidney graft survival, The rate of patients survival, and the successful rate of steroid withdrawal
Key secondary outcomes The incidence rate of cytomegalovirus infection, kidney graft function (e.g. eGFR or serum creatinine), The rate of adverse events, and the rate of biopsy-proven chronic allograft nephropathy

Base
Study type

Study design
Basic design Single arm
Randomization Non-randomized
Randomization unit
Blinding Open -no one is blinded
Control Historical
Stratification
Dynamic allocation
Institution consideration
Blocking
Concealment

Intervention
No. of arms 1
Purpose of intervention Treatment
Type of intervention
Medicine Maneuver
Interventions/Control_1 Everolimus intake, kidney transplantation, 3 years, Set trough level between 3 to 8 ng/ml
Interventions/Control_2
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
16 years-old <=
Age-upper limit
70 years-old >=
Gender Male and Female
Key inclusion criteria Living related kidney transplant patients who is between 16 and 70 years old age.
Who can make informed consent properly.
Key exclusion criteria The patients who cannot make informed consent properly.
Who is unable to visit hospitals on scheduled dates.
Who is pregnant.
Who has an allergy to everolimus.
Target sample size 100

Research contact person
Name of lead principal investigator
1st name
Middle name
Last name Oya Mototsugu
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address Shinanomachi 35, Shinjyuku-ku, Tokyo
TEL 03-5363-3825
Email moto-oya@z3.keio.jp

Public contact
Name of contact person
1st name
Middle name
Last name Morita Shinya
Organization Keio University School of Medicine
Division name Department of Urology
Zip code
Address Shinanomachi 35, Shinjuku-ku, Tokyo
TEL 03-5363-3825
Homepage URL
Email morishin75@yahoo.co.jp

Sponsor
Institute Keio University School of Medicine
Institute
Department

Funding Source
Organization Not applicable
Organization
Division
Category of Funding Organization Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor Department of Nephrology, Toho University School of Medicine, Department of Urology, Fujita Health University Hospital
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 慶應義塾大学病院(東京都)、東邦大学大森病院(東京都)、藤田保健衛生大学病院(愛知県)

Other administrative information
Date of disclosure of the study information
2015 Year 05 Month 14 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 Enrolling by invitation
Date of protocol fixation
2012 Year 11 Month 26 Day
Date of IRB
Anticipated trial start date
2012 Year 11 Month 26 Day
Last follow-up date
2020 Year 10 Month 31 Day
Date of closure to data entry
2020 Year 10 Month 31 Day
Date trial data considered complete
2020 Year 10 Month 31 Day
Date analysis concluded
2020 Year 10 Month 31 Day

Other
Other related information

Management information
Registered date
2015 Year 05 Month 14 Day
Last modified on
2015 Year 05 Month 14 Day


Link to view the page
URL(English) https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000020342

Research Plan
Registered date File name

Research case data specifications
Registered date File name

Research case data
Registered date File name


Contact us.