UMIN-CTR Clinical Trial
| Unique ID issued by UMIN | UMIN000003767 |
|---|---|
| Receipt number | R000004563 |
| Scientific Title | Systemic cyclosporine administration for high-risk corneal transplantation |
| Date of disclosure of the study information | 2010/06/20 |
| Last modified on | 2012/06/20 16:46:50 |
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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
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
jun@eyebank.or.jp
Sponsor or person
Institute
Tokyo Dental College, Ichikawa General Hospital
Institute
Department
Personal name
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
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
Value
https://center6.umin.ac.jp/cgi-open-bin/ctr_e/ctr_view.cgi?recptno=R000004563
| Research Plan | |
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| Registered date | File name |
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| Registered date | File name |
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