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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00492895
Other study ID # 2007DR2040
Secondary ID
Status Completed
Phase Phase 4
First received June 19, 2007
Last updated January 28, 2013
Start date June 2007
Est. completion date March 2011

Study information

Verified date January 2013
Source University of Zurich
Contact n/a
Is FDA regulated No
Health authority Switzerland: Swissmedic
Study type Interventional

Clinical Trial Summary

Photosensitivity of the skin to UVA and UVB will be determined


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


Recruitment information / eligibility

Status Completed
Enrollment 25
Est. completion date March 2011
Est. primary completion date December 2010
Accepts healthy volunteers Accepts Healthy Volunteers
Gender Both
Age group 18 Years and older
Eligibility Inclusion criteria:

- Renal transplant recipients under azathioprin

Exclusion criteria:

- Treatment with Prograf (Tacrolimus)

Study Design

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Diagnostic


Related Conditions & MeSH terms


Intervention

Drug:
Discontinuation of Azathioprin
Discontinuation of Azathioprin

Locations

Country Name City State
Switzerland Clinic for Dermatology, University Hospital of Zurich Zurich

Sponsors (1)

Lead Sponsor Collaborator
University of Zurich

Country where clinical trial is conducted

Switzerland, 

References & Publications (1)

Hofbauer GF, Attard NR, Harwood CA, McGregor JM, Dziunycz P, Iotzova-Weiss G, Straub G, Meyer R, Kamenisch Y, Berneburg M, French LE, Wüthrich RP, Karran P, Serra AL. Reversal of UVA skin photosensitivity and DNA damage in kidney transplant recipients by — View Citation

Outcome

Type Measure Description Time frame Safety issue
Primary Photosensitivity of the skin to UVA and UVB 2 years No
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