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Acitretin Plasma Levels Under Hemodialysis

This study has suspended participant recruitment.
(lack of subjects)
Sponsor:
Information provided by:
University of Zurich
ClinicalTrials.gov Identifier:
NCT00488384
First received: June 19, 2007
Last updated: August 18, 2011
Last verified: August 2011
History of Changes
  Purpose

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 Intervention Phase
Carcinoma, Squamous Cell
 Drug: Chemopreventive application (Acitretin)
 Phase 4

Study Type: Interventional
Study Design: Allocation: Non-Randomized
Endpoint Classification: Pharmacokinetics/Dynamics Study
Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Acitretin Plasma Levels Under Hemodialysis

Resource links provided by NLM:

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

Further study details as provided by University of Zurich:

Primary Outcome Measures:
  • Plasma levels acitretin [ Time Frame: 2009 ] [ Designated as safety issue: No ]

Estimated Enrollment: 2009
Study Start Date: June 2007
Estimated Study Completion Date: June 2015
Estimated Primary Completion Date: December 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
a
single arm only. Only open label treatment anticipated
 Drug: Chemopreventive application (Acitretin)
Chemopreventive application (Acitretin)
Other Name: Chemopreventive application (Acitretin)

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
  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
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
Please refer to this study by its ClinicalTrials.gov identifier: NCT00488384

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

No publications provided

Responsible Party: hofbauer, university hospital zurich
ClinicalTrials.gov Identifier: NCT00488384     History of Changes
Other Study ID Numbers: 2007DR2065 EK674
Study First Received: June 19, 2007
Last Updated: August 18, 2011
Health Authority: Switzerland: Swissmedic

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

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

ClinicalTrials.gov processed this record on May 16, 2013