Back to resultsAcitretin Plasma Levels Under Hemodialysis
Primary Purpose
Carcinoma, Squamous Cell
Status
Withdrawn
Phase
Phase 4
Locations
Switzerland
Study Type
Interventional
Intervention
Chemopreventive application (Acitretin)
Sponsored by
About this trial
This is an interventional prevention trial for Carcinoma, Squamous Cell focused on measuring Squamous cell carcinoma of the skin under hemodialysis
Eligibility Criteria
Inclusion criteria:
- Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin
Exclusion criteria:
- Hepatopathy
- Pregnancy
Sites / Locations
- Clinic for Dermatology University Hospital of Zurich
Arms of the Study
Arm 1
Arm Type
Other
Arm Label
a
Arm Description
single arm only. Only open label treatment anticipated
Outcomes
Primary Outcome Measures
Plasma levels acitretin
Secondary Outcome Measures
Full Information
NCT ID
NCT00488384
First Posted
June 19, 2007
Last Updated
July 17, 2018
Sponsor
Günther Hofbauer
Collaborators
University of Zurich
1. Study Identification
Unique Protocol Identification Number
NCT00488384
Brief Title
Acitretin Plasma Levels Under Hemodialysis
Official Title
Acitretin Plasma Levels Under Hemodialysis
Study Type
Interventional
2. Study Status
Record Verification Date
July 2018
Overall Recruitment Status
Withdrawn
Why Stopped
lack of subjects
Study Start Date
June 2007 (Actual)
Primary Completion Date
December 2014 (Actual)
Study Completion Date
June 2018 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Günther Hofbauer
Collaborators
University of Zurich
4. Oversight
Data Monitoring Committee
No
5. Study Description
Brief Summary
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year.
Detailed Description
Acitretin is given to hemodialysis patients who have developed in-situ or invasive squamous cell carcinoma of the skin in increasing doses up to 25 mg daily for one year. Plasma levels of acitretin will be monitored and influence of hemodialysis on acitretin plasma levels will be determined. Number of in-situ or invasive squamous cell carcinoma of the skin cases will be determined.
Trial with medicinal product
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Carcinoma, Squamous Cell
Keywords
Squamous cell carcinoma of the skin under hemodialysis
7. Study Design
Primary Purpose
Prevention
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
a
Arm Type
Other
Arm Description
single arm only. Only open label treatment anticipated
Intervention Type
Drug
Intervention Name(s)
Chemopreventive application (Acitretin)
Intervention Description
Chemopreventive application (Acitretin)
Primary Outcome Measure Information:
Title
Plasma levels acitretin
Time Frame
2009
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion criteria:
Hemodialyis patients with at least one case of in-situ or invasive squamous cell carcinoma of the skin
Exclusion criteria:
Hepatopathy
Pregnancy
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
01 Studienregister MasterAdmins
Organizational Affiliation
UniversitaetsSpital Zuerich
Official's Role
Study Director
Facility Information:
Facility Name
Clinic for Dermatology University Hospital of Zurich
City
Zurich
Country
Switzerland
12. IPD Sharing Statement
Learn more about this trial
Acitretin Plasma Levels Under Hemodialysis
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