Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients - Tabular View

This Tabular View shows the required WHO registration data elements as marked by ^†

Tracking Information

First Received Date ^†

June 19, 2007

Last Updated Date

June 5, 2008

Start Date ^†

June 2007

Current Primary Outcome Measures ^†

Photosensitivity of the skin to UVA and UVB [ Time Frame: 2 years ] [ Designated as safety issue: No ]

Original Primary Outcome Measures ^†

Same as current

Change History

Complete list of historical versions of study NCT00492895 on ClinicalTrials.gov Archive Site

Current Secondary Outcome Measures ^†

Original Secondary Outcome Measures ^†

Descriptive Information

Brief Title ^†

Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

Official Title ^†

Photosensitivity of the Skin Under Azathioprin in Renal Transplant Recipients

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

Study Phase

Phase IV

Study Type ^†

Interventional

Study Design ^†

Diagnostic, Randomized, Open Label, Dose Comparison, Crossover Assignment, Efficacy Study

Condition ^†

Photosensitivity

Intervention ^†

Drug: Discontinuation of Azathioprin

Study Arms / Comparison Groups

Other: one arm only. Crossover study

Publications *

* Includes publications given by the data provider as well as publications identified by National Clinical Trials Identifier (NCT ID) in Medline.

Recruitment Information

Recruitment Status ^†

Recruiting

Enrollment ^†

2009

Estimated Completion Date

June 2009

Estimated Primary Completion Date

December 2008 (final data collection date for primary outcome measure)

Eligibility Criteria ^†

Inclusion criteria:

Renal transplant recipients under azathioprin

Exclusion criteria:

Treatment with Prograf (Tacrolimus)

Gender

Both

Ages

18 Years and older

Accepts Healthy Volunteers

Yes

Contacts ^††

Contact: Günther FL Hofbauer, MD

+41 (0)44 255 11 11

hofbauer@usz.ch

Location Countries ^†

Switzerland

Expanded Access Status

Administrative Information

NCT ID ^†

NCT00492895

Responsible Party

Hofbauer Günther, Unversity Hospital Zürich

Secondary IDs ^††

Study Sponsor ^†

University of Zurich

Collaborators ^††

Investigators ^†

Study Director:

01 Studienregister MasterAdmins

UniversitaetsSpital Zuerich

Information Provided By

University of Zurich

Verification Date

June 2008

^† Required WHO trial registration data element.
^†† WHO trial registration data element that is required only if it exists.