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Acitretin Plasma Levels Under Hemodialysis

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ClinicalTrials.gov Identifier: NCT00488384
Recruitment Status : Suspended (lack of subjects)
First Posted : June 20, 2007
Last Update Posted : June 11, 2015
Sponsor:
Collaborator:
Information provided by (Responsible Party):

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.

Condition or disease Intervention/treatment Phase
Carcinoma, Squamous Cell Drug: Chemopreventive application (Acitretin) Phase 4

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

Study Design

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 2009 participants
Allocation: Non-Randomized
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: Acitretin Plasma Levels Under Hemodialysis
Study Start Date : June 2007
Primary Completion Date : December 2014
Estimated Study Completion Date : June 2018

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Dialysis
Drug Information available for: Acitretin
U.S. FDA Resources

Arms and Interventions

Arm Intervention/treatment
a
single arm only. Only open label treatment anticipated
Drug: Chemopreventive application (Acitretin)
Chemopreventive application (Acitretin)


Outcome Measures

Primary Outcome Measures :
  1. Plasma levels acitretin [ Time Frame: 2009 ]

Eligibility Criteria

Information from the National Library of Medicine

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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
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
Contacts and Locations

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00488384


Locations
Switzerland
Clinic for Dermatology University Hospital of Zurich
Zurich, Switzerland
Sponsors and Collaborators
Günther Hofbauer
University of Zurich
Investigators
Study Director: 01 Studienregister MasterAdmins UniversitaetsSpital Zuerich
More Information

Responsible Party: Günther Hofbauer, senior staff physician, University of Zurich
ClinicalTrials.gov Identifier: NCT00488384     History of Changes
Other Study ID Numbers: 2007DR2065 EK674
First Posted: June 20, 2007    Key Record Dates
Last Update Posted: June 11, 2015
Last Verified: June 2015

Keywords provided by Günther Hofbauer, University of Zurich:
Squamous cell carcinoma of the skin under hemodialysis

Additional relevant MeSH terms:
Carcinoma, Squamous Cell
Carcinoma
Neoplasms, Glandular and Epithelial
Neoplasms by Histologic Type
Neoplasms
Neoplasms, Squamous Cell
Acitretin
Keratolytic Agents
Dermatologic Agents