Back to resultsPhotosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Primary Purpose
Skin Cancer
Status
Completed
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Discontinuation of Azathioprin
Sponsored by
About this trial
This is an interventional diagnostic trial for Skin Cancer
Eligibility Criteria
Inclusion criteria:
- Renal transplant recipients under azathioprin
Exclusion criteria:
- Treatment with Prograf (Tacrolimus)
Sites / Locations
- Clinic for Dermatology, University Hospital of Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
A
Arm Description
one arm only. Crossover study
Outcomes
Primary Outcome Measures
Photosensitivity of the skin to UVA and UVB
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT00492895
Brief Title
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Official Title
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
Study Type
Interventional
2. Study Status
Record Verification Date
January 2013
Overall Recruitment Status
Completed
Study Start Date
June 2007 (undefined)
Primary Completion Date
December 2010 (Actual)
Study Completion Date
March 2011 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Photosensitivity of the skin to UVA and UVB will be determined
Detailed Description
Photosensitivity of the skin to UVA and UVB in renal transplant recipients with and without azathioprine will be determined. Azathioprine will be discontinued and photosensitivity determined after a wash-out period of three months
Trial with medicinal product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Skin Cancer
7. Study Design
Primary Purpose
Diagnostic
Study Phase
Phase 4
Interventional Study Model
Crossover Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
25 (Actual)
8. Arms, Groups, and Interventions
Arm Title
A
Arm Type
Other
Arm Description
one arm only. Crossover study
Intervention Type
Drug
Intervention Name(s)
Discontinuation of Azathioprin
Intervention Description
Discontinuation of Azathioprin
Primary Outcome Measure Information:
Title
Photosensitivity of the skin to UVA and UVB
Time Frame
2 years
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Renal transplant recipients under azathioprin
Exclusion criteria:
Treatment with Prograf (Tacrolimus)
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Günther Hofbauer, M.D
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Principal Investigator
Facility Information:
Facility Name
Clinic for Dermatology, University Hospital of Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Citations:
PubMed Identifier
21943390
Citation
Hofbauer GF, Attard NR, Harwood CA, McGregor JM, Dziunycz P, Iotzova-Weiss G, Straub G, Meyer R, Kamenisch Y, Berneburg M, French LE, Wuthrich RP, Karran P, Serra AL. Reversal of UVA skin photosensitivity and DNA damage in kidney transplant recipients by replacing azathioprine. Am J Transplant. 2012 Jan;12(1):218-25. doi: 10.1111/j.1600-6143.2011.03751.x. Epub 2011 Sep 22.
Results Reference
result
Learn more about this trial
Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients
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