Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol (PROSKIN)

The recruitment status of this study is unknown because the information has not been verified recently.
Verified May 2009 by Charite University, Berlin, Germany.
Recruitment status was  Active, not recruiting
Sponsor:
Information provided by:
Charite University, Berlin, Germany
ClinicalTrials.gov Identifier:
NCT00866684
First received: March 19, 2009
Last updated: May 18, 2009
Last verified: May 2009
  Purpose

Transplant recipients have a high risk to develop skin malignancies. This effect depends on the one hand on the immunosuppressive drugs themselves (i.e., azathioprine) and relates on the other hand on the dosage (i.e., calcineurin-inhibitors). Based on the encouraging results of previous, retrospective studies on patients treated with Sirolimus (SRL), these patients should be switched to an immunosuppressive regime including SRL, decreasing the dosage of calcineurin-inhibitors or converting from former immunosuppression. A conversion to a SRL-based therapy is effective in immunosuppression and safe regarding graft and patient survival.

This study was designed to assess whether a switch to a SRL-immunosuppressive therapy decreases the incidence/reoccurrence of skin neoplasm.


Condition Intervention Phase
Kidney Transplantation
Skin Cancer
Drug: Sirolimus
Drug: Azathioprine
Drug: Mycophenolate
Drug: Ciclosporin
Drug: Tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: Prevention of Skin Cancer in High Risk Patients After Conversion to a Sirolimus-Based Immunosuppressive Protocol

Resource links provided by NLM:


Further study details as provided by Charite University, Berlin, Germany:

Primary Outcome Measures:
  • Progression of actinic keratosis I and II to III or invasive squamous cell carcinoma (SCC) or incidence/reoccurrence of neoplastic skin tumors [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Patient and graft survival rates, Incidence of non-cutaneous cancers and of selected AEs, Development of renal function, Renal biopsy changes, Development of proteinuria after conversation to SRL, Incidence and development of actinic keratosis I and II [ Designated as safety issue: Yes ]

Estimated Enrollment: 280
Study Start Date: January 2007
Estimated Study Completion Date: July 2011
Estimated Primary Completion Date: January 2011 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Patients will receive Sirolimus in addition to their previous immunosuppressive therapy.
Drug: Sirolimus
Dosage form: coated tablet; Dosage: 4-8 micrograms/litre; Route of administration: oral use; Frequency: one tablet per day; Duration: 24 month
Other Name: Rapamune, ATC code: L04AA10
Active Comparator: 2
Patients will stay on their previous immunosuppressive regimen.
Drug: Azathioprine
Dosage form: Coated tablet; dosage: 1-4 milligrams/kilogram; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AX01
Drug: Mycophenolate
Dosage form: Tablet; dosage: 2 gram; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA06
Drug: Ciclosporin
Dosage form: Capsule; Dosage: 50-80 micrograms/litre; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA01
Drug: Tacrolimus
Dosage form: Capsule; dosage: 3-5 micrograms/litre; Frequency: daily; Duration: 24 month
Other Name: ATC code: L04AA05

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Recipients of renal allograft with current actinic keratosis I or II or successfully treated actinic keratosis III (inclusion possible immediately after completed wound healing from surgical excision), invasive squamous cell carcinoma (SCC), basal cell carcinoma and/or premalignant neoplastic skin lesions
  • Age 18 years and older
  • Minimum period of 6 month after renal transplantation
  • Stable renal function and a calculated creatinine clearance of at least 40 ml/min
  • Written informed consent
  • Proteinuria ≤ 800 mg/d at time of enrolment
  • Successfully treated solid tumor (no recurrence or metastasis in the last 2 years)

Exclusion Criteria:

  • Current Sirolimus- or Everolimus- intake
  • Instable graft function (creatinine clearance < 40 ml/min)
  • Graft rejection within the 3 previous months
  • Proteinuria > 800 mg/d
  • Non-controlled hyperlipidemia (Cholesterol >7,8 mmol/l, Triglycerides > 4)
  • Leucopenia < 2500/nl
  • Thrombocytopenia < 90/nl
  • Pregnancy or breastfeeding
  • Women of childbearing age without highly effective contraception (= defined as those which result in a low failure rate (i.e. less than 1 % per year))
  • Known allergy to macrolides
  • Current participation in other studies
  • Refusal to sign informed consent form
  • Neoplasm other than defined as inclusion criteria
  • All contraindications to SRL (see package insert, appendix)
  • Persons who are detained officially or legally to an official institute
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its ClinicalTrials.gov identifier: NCT00866684

Locations
Germany
Universitätsklinikum Erlangen, Hautklinik
Erlangen, Bavaria, Germany, 91052
Universitätsklinikum Erlangen, Medizinische Klinik IV
Erlangen, Bavaria, Germany, 91054
Klinikum der LMU München, Klinik und Poliklinik für Dermatologie
München, Bavaria, Germany, 80337
Klinikum rechts der Isar, II. Medizinische Klinik und Poliklinik
München, Bavaria, Germany, 81675
Klinikum rechts der Isar, Klinik und Poliklinik für Dermatologie und Allergologie
München, Bavaria, Germany, 80802
Klinikum der LMU München, Medizinische Poliklinik Innenstadt
München, Bavaria, Germany, 80336
Universität Regensburg, Dermatologie
Regensburg, Bavaria, Germany, 93053
Universität Regensburg, Nephrologie Innere Medizin II
Regensburg, Bavaria, Germany, 93053
Kliniken der Stadt Köln, Medizinische Klinik I
Köln, North Rhine-Westphalia, Germany, 51109
Universitätsklinikum Münster, Med. Klinik und Poliklinik D
Münster, North Rhine-Westphalia, Germany, 48149
Universitätsklinikum Münster, Klinik und Poliklinik für Hautkrankheiten
Münster, North Rhine-Westphalia, Germany, 48149
HELIOS Klinikum Wuppertal, Zentrum für Dermatologie, Allergologie und Umweltmedizin
Wuppertal, North Rhine-Westphalia, Germany, 42283
Universitätsklinikum Schleswig-Holstein, Klinik für Dermatologie, Venerologie und Allergologie
Kiel, Schleswig-Holstein, Germany, 24105
Universitätsklinikum Schleswig-Holstein, Klinik für Nieren- und Hochdruckkrankheiten
Kiel, Schleswig-Holstein, Germany, 24105
Charité Universitätsmedizin, Klinik für Dermatologie, Venerologie und Allergologie
Berlin, Germany, 10117
Sponsors and Collaborators
Charite University, Berlin, Germany
Investigators
Principal Investigator: Petra Reinke, Prof. Dr. Charite University, Berlin, Germany
  More Information

No publications provided

Responsible Party: Petra Reinke, Prof. Dr. med., Charité Universitätsmedizin Berlin, Nephrologie u. internistische Intensivmed.
ClinicalTrials.gov Identifier: NCT00866684     History of Changes
Other Study ID Numbers: PROSKIN 01
Study First Received: March 19, 2009
Last Updated: May 18, 2009
Health Authority: Germany: Federal Institute for Drugs and Medical Devices

Keywords provided by Charite University, Berlin, Germany:
renal transplant-patients with high-risk for skin cancer

Additional relevant MeSH terms:
Skin Neoplasms
Neoplasms by Site
Neoplasms
Skin Diseases
Immunosuppressive Agents
Azathioprine
Sirolimus
Everolimus
Immunologic Factors
Physiological Effects of Drugs
Pharmacologic Actions
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antimetabolites, Antineoplastic
Antineoplastic Agents
Therapeutic Uses
Antirheumatic Agents
Anti-Bacterial Agents
Anti-Infective Agents
Antibiotics, Antineoplastic
Antifungal Agents

ClinicalTrials.gov processed this record on September 30, 2014