Trial record 2 of 282 for:    "Skin Neoplasms"

Study Evaluating the Effect of Sirolimus on Non-Melanoma Skin Cancer in Kidney Transplant Recipients

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier:
NCT00129961
First received: August 1, 2005
Last updated: April 9, 2012
Last verified: April 2012
  Purpose

The purpose of this study is to determine the effect of sirolimus on the prevention of new non-melanoma skin cancer (NMSC) in kidney transplant recipients.


Condition Intervention Phase
Skin Neoplasms
Kidney Transplantation
Drug: sirolimus
Drug: cyclosporine or tacrolimus
Phase 4

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Prevention
Official Title: A Randomized, Open-Label Study to Compare the Rate of New Non-Melanoma Skin Cancer in Maintenance Renal Allograft Recipients Converted to a Sirolimus-based Regimen Versus Continuation of a Calcineurin Inhibitor-based Regimen

Resource links provided by NLM:


Further study details as provided by Wyeth is now a wholly owned subsidiary of Pfizer:

Primary Outcome Measures:
  • New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    The number of new biopsy-confirmed NMSC lesions per subject per year was calculated by summarizing the total number of new BCC and SCC lesions reported over the observation period and standardizing it to an annual rate by multiplying by 365 and dividing by days on study.


Secondary Outcome Measures:
  • Time to First Biopsy Confirmed New NMSC Lesion. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    The time to first biopsy confirmed new NMSC lesion starts at 1 day post randomization to biopsy and/or treatment of newly confirmed NMSC lesion.

  • Number of Lesion Free Subjects [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    The overall number of subjects who were lesion free were compared between treatment groups with the Cochran Mantel Haenszel test stratified by baseline NMSC stratum. Within each stratum, the Fisher exact test was used to compare the proportions of lesion free subjects between treatment groups.

  • Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC) [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Grade Distribution of NMSC Lesions [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).

  • Number of Recurrent NMSC Lesions Per Subject-year [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.

  • Subjects Reporting Incidence of Metastatic Disease Related to NMSC. [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    The number of subjects with metastatic disease related to NMSC.

  • Death Due to NMSC [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Number of Subjects Who Discontinue Assigned Therapy [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Nankivell-Calculated Glomerular Filtration Rate (GFR) [ Time Frame: At 24 months (week 104) ] [ Designated as safety issue: No ]
    GFR is an index of kidney function. GFR describes the flow rate of filtered fluid through the kidney. GFR can be measured directly or estimated using established formulas. For this study, GFR was calculated using Nankivell. A normal GFR is > 90 mL/min, although children and older people usually have a lower GFR. Lower values indicate poor kidney function. A GFR <15 is consistent with kidney failure.

  • Serum Creatinine Level [ Time Frame: At 24 months (Week 104) ] [ Designated as safety issue: No ]
    Serum creatinine is an indicator of kidney function. Creatinine is a substance formed from the metabolism of creatinine, commonly found in blood, urine, and muscle tissue. It is removed from the blood by the kidneys and excreted in urine. An increased level of creatinine in the blood indicates decreased kidney function. Normal adult blood levels of creatinine are 0.5 to 1.1 mg/dL for females and 0.6 to 1.2 mg/dL for males, however the normal values are age-dependent as elderly patients typically have smaller muscle mass.

  • Number of Participants That Died [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Graft Survival Measured by Graft Loss [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
    Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.

  • Number of Subjects With Biopsy-Confirmed Acute Rejection [ Time Frame: up to 24 months ] [ Designated as safety issue: No ]
  • Spot Urine Protein:Creatinine Ratio [ Time Frame: At 24 months (Week 104) ] [ Designated as safety issue: No ]
    Subjects' urine protein:creatinine ratios were summarized by each scheduled visit, and the nonparametric Wilcoxon rank sum test was used to compare the difference between groups.


Enrollment: 86
Study Start Date: August 2005
Study Completion Date: January 2009
Primary Completion Date: January 2009 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Conversion to a sirolimus-based regimen
Drug: sirolimus
Active Comparator: 2
Continuation of a CNI-based regimen
Drug: cyclosporine or tacrolimus

  Eligibility

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

Inclusion Criteria:

  • Kidney transplant at least 1 year prior
  • Subjects with a functioning renal allograft with calculated glomerular filtration rate (GFR) ≥40mL/min (Nankivell method) and proteinuria ≤500mg/day.
  • Stable on cyclosporine or tacrolimus-based multi-drug immunosuppressive regimen
  • History of NMSC within last 3 years

Exclusion Criteria:

  • History of other cancer within last 3 years
  • NMSC with metastatic disease or more than 20 NMSC lesions in last 12 months
  • Multiple organ transplant
  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: NCT00129961

  Show 23 Study Locations
Sponsors and Collaborators
Wyeth is now a wholly owned subsidiary of Pfizer
Investigators
Study Director: Medical Monitor Wyeth is now a wholly owned subsidiary of Pfizer
Principal Investigator: Trial Manager For Canada, clintrialparticipation@wyeth.com
Principal Investigator: Trial Manager For Australia, medinfo@wyeth.com
Principal Investigator: Trial Manager For New Zealand, medinfo@wyeth.com
  More Information

No publications provided by Wyeth is now a wholly owned subsidiary of Pfizer

Additional publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Wyeth is now a wholly owned subsidiary of Pfizer
ClinicalTrials.gov Identifier: NCT00129961     History of Changes
Other Study ID Numbers: 0468H1-407
Study First Received: August 1, 2005
Results First Received: January 29, 2010
Last Updated: April 9, 2012
Health Authority: Australia: Department of Health and Ageing Therapeutic Goods Administration

Keywords provided by Wyeth is now a wholly owned subsidiary of Pfizer:
Kidney
Transplant
Skin Cancer

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

ClinicalTrials.gov processed this record on August 19, 2014