UMIN-CTR Clinical Trial

Basic information
Public title	Systemic cyclosporine administration for high-risk corneal transplantation
Acronym	Cyclosporine for high-risk corneal transplantation
Scientific Title	Systemic cyclosporine administration for high-risk corneal transplantation
Scientific Title:Acronym	Cyclosporine for high-risk corneal transplantation
Region	Japan

Condition
Condition	High-risk corneal transplantation
Classification by specialty	Ophthalmology
Classification by malignancy	Others
Genomic information	NO

Objectives
Narrative objectives1	To study whether or not systemic administration of cyclosporine is beneficial for suppressing immunological rejection and improving graft survival
Basic objectives2	Safety,Efficacy
Basic objectives -Others
Trial characteristics_1	Confirmatory
Trial characteristics_2	Pragmatic
Developmental phase	Phase IV

Assessment
Primary outcomes	Incidence of graft rejection following corneal transplantation
Key secondary outcomes	Incidence and severity of local or systemic complications

Base
Study type	Interventional

Study design
Basic design	Parallel
Randomization	Randomized
Randomization unit	Individual
Blinding	Open -no one is blinded
Control	Active
Stratification	YES
Dynamic allocation	NO
Institution consideration	Institution is not considered as adjustment factor.
Blocking	NO
Concealment	Pseudo-randomization

Intervention
No. of arms	2
Purpose of intervention	Treatment
Type of intervention	Medicine
Interventions/Control_1	Systemic cyclosporine administration. Cyclosporine is used for at least 6 months following corneal transplantation with C2 blood level with approximately 800 ng/ml
Interventions/Control_2	Topical corticosteroids. 0.1% dexamethasone eyedrop is used after corneal transplantation 5 times a day. The dose is gradually tapered, but not discontinued during the observation period.
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	Recipients of high-risk corneal transplantation which is defined as one of the following conditions; 1) Presence of deep corneal neovascularization with more than one quadrant 2) History of previous penetrating keratoplasty (regrafting)
Key exclusion criteria	1) poorly controlled diabetes mellitus 2) poorly controlled hypertension 3) abnormal kidney function 4) abnormal liver function 5) active ocular infection 6) active systemic infectious diseases 7) uncontrollable ocular hypertension 8) severe corneal limbal dysfunction
Target sample size	20

Research contact person
Name of lead principal investigator	1st name Middle name Last name Jun Shimazaki
Organization	Tokyo Dental College, Ichikawa General Hospital
Division name	Department of Ophthalmology
Zip code
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	0473-22-0151
Email

Public contact
Name of contact person	1st name Middle name Last name Jun Shimazaki
Organization	Tokyo Dental College, Ichikawa General Hospital
Division name	Department of Ophthalmology
Zip code
Address	5-11-13 Sugano, Ichikawa, Chiba, Japan
TEL	0473-22-0151
Homepage URL	http://www.tdc-eye.com
Email	jun@eyebank.or.jp

Sponsor
Institute	Tokyo Dental College, Ichikawa General Hospital
Institute
Department

Funding Source
Organization	none
Organization
Division
Category of Funding Organization	Self funding
Nationality of Funding Organization

Other related organizations
Co-sponsor	none
Name of secondary funder(s)	none

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	東京歯科大学市川総合病院（千葉県）

Other administrative information
Date of disclosure of the study information	2010 Year 06 Month 20 Day

Related information
URL releasing protocol	http://download.journals.elsevierhealth.com/pdfs/journals/0002-9394/PIIS0002939411000572.pdf
Publication of results	Published

Result
URL related to results and publications	http://download.journals.elsevierhealth.com/pdfs/journals/0002-9394/PIIS0002939411000572.pdf
Number of participants that the trial has enrolled
Results	1. There was no obvious effect in systemic cyclosporine administration for prevention of rejection in patients with high-risk corneal transplantation. 2. Since approximately one-fourth of patients discontinued cyclosporine due to systemic side effects, the use of the drug is not recommended especially for elderly patients.
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	2010 Year 06 Month 01 Day
Date of IRB
Anticipated trial start date	2010 Year 06 Month 01 Day
Last follow-up date	2011 Year 05 Month 01 Day
Date of closure to data entry	2011 Year 06 Month 01 Day
Date trial data considered complete	2011 Year 06 Month 01 Day
Date analysis concluded	2011 Year 07 Month 01 Day

Other
Other related information

Management information
Registered date	2010 Year 06 Month 16 Day
Last modified on	2012 Year 06 Month 20 Day

Link to view the page
URL(English)	https://upload.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004563

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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