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Skin NeoplasmsPhase 4NCT00129961

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

A Phase 4 study testing sirolimus and cyclosporine or tacrolimus in people with Skin Neoplasms and Kidney Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 23 sites in 4 countries.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial summary

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. Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Skin Neoplasms, Kidney Transplantation
What is being tested?
sirolimus and cyclosporine or tacrolimus
Could I receive a placebo?
No, everyone receives an active treatment
How many people
86 participants
Where
23 sitesin 4 countries
Study dates
Aug 2005to Jan 2009
Phase
Phase 4
Are there results?
Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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

Who cannot join

  • 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

Trial locations and contacts

23 sites in 4 countries.

23 sites in 4 countries

United States12 sites

  • Study site

    Atlanta, Georgia, 30309

  • Study site

    Charleston, South Carolina, 29425

  • Study site

    Chicago, Illinois, 60612

  • Study site

    Cincinnati, Ohio, 45267

  • Study site

    Durham, North Carolina, 27710

  • Study site

    Gainesville, Florida, 32610

  • Study site

    Madison, Wisconsin, 53792

  • Study site

    Nashville, Tennessee, 37232

  • Study site

    Philadelphia, Pennsylvania, 19102

  • Study site

    Portland, Oregon, 97239

  • Study site

    San Diego, California, 92103

  • Study site

    San Francisco, California, 94143

Other trials in United States

Australia9 sites

  • Study site

    Adelaide, SA 5000

  • Study site

    Camperdown, New South Wales, 2050

  • Study site

    Clayton, VIC 3169

  • Study site

    Herston, QLD 4029

  • Study site

    Parkville, VIC 3050

  • Study site

    Randwick, NSW 2031

  • Study site

    Westmead, NSW 2145

  • Study site

    Woodville, South Australia, 5011

  • Study site

    Wooloongabba, Queensland, 4102

Other trials in Australia

Canada1 site

  • Study site

    Vancouver, British Columbia, V5Z 1M9

Other trials in Canada

New Zealand1 site

  • Study site

    Grafton, Auckland, 1031

Other trials in New Zealand

About this study

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

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.

Being tested
sirolimus, cyclosporine or tacrolimus
Keywords
Kidney, Transplant, Skin Cancer
Medical subject headings
Skin Neoplasms

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Study groups in NCT00129961
Study groupRoleWhat they receive
1ExperimentalConversion to a sirolimus-based regimen
Receives: Drug: sirolimus
2Active comparatorContinuation of a CNI-based regimen
Receives: Drug: cyclosporine or tacrolimus

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year

    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.

    Measured: up to 24 months

Secondary outcomes (14)

  1. Time to First Biopsy Confirmed New NMSC Lesion.

    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.

    Measured: up to 24 months

  2. Number of Lesion Free Subjects

    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.

    Measured: up to 24 months

  3. Percentage of Patients With New Biopsy-confirmed NMSC: Squamous Cell Carcinoma (SCC) and Basal Cell Carcinoma (BCC)

    Measured: up to 24 months

  4. Grade Distribution of NMSC Lesions

    Number of subjects with at least 1 biopsy-confirmed new squamous cell carcinoma (SCC) or basal cell carcinoma (BCC).

    Measured: up to 24 months

  5. Number of Recurrent NMSC Lesions Per Subject-year

    Recurrent NMSC lesions is defined as recurring at the site of a previously treated lesion.

    Measured: up to 24 months

  6. Subjects Reporting Incidence of Metastatic Disease Related to NMSC.

    The number of subjects with metastatic disease related to NMSC.

    Measured: up to 24 months

  7. Death Due to NMSC

    Measured: up to 24 months

  8. Number of Subjects Who Discontinue Assigned Therapy

    Measured: up to 24 months

  9. Nankivell-Calculated Glomerular Filtration Rate (GFR)

    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.

    Measured: At 24 months (week 104)

  10. Serum Creatinine Level

    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.

    Measured: At 24 months (Week 104)

  11. Number of Participants That Died

    Measured: up to 24 months

  12. Graft Survival Measured by Graft Loss

    Graft loss was defined as physical loss (nephrectomy), functional loss (necessitating maintenance dialysis for >8 consecutive weeks), retransplant, or death.

    Measured: up to 24 months

  13. Number of Subjects With Biopsy-Confirmed Acute Rejection

    Measured: up to 24 months

  14. Spot Urine Protein:Creatinine Ratio

    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.

    Measured: At 24 months (Week 104)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted12 Aug 2005 (estimated)
  2. Study startAug 2005
  3. Primary completionJan 2009
  4. Study completionJan 2009

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 4
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
86 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT00129961
Sponsor's protocol ID
0468H1-407
Status last verified
Apr 2012
First submitted
1 Aug 2005
Last updated
11 Apr 2012
Data monitoring committee
No

Publications

  • Campbell SB, Walker R, Tai SS, Jiang Q, Russ GR. Randomized controlled trial of sirolimus for renal transplant recipients at high risk for nonmelanoma skin cancer. Am J Transplant. 2012 May;12(5):1146-56. doi: 10.1111/j.1600-6143.2012.04004.x. Epub 2012 Mar 15.

    PubMed 22420843

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing sirolimus and cyclosporine or tacrolimus in people with Skin Neoplasms and Kidney Transplantation, run by Wyeth is now a wholly owned subsidiary of Pfizer at 23 sites in 4 countries.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 4 inclusion and 3 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 11 Apr 2012. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 23 sites in United States, Australia, Canada, New Zealand. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 23 Mar 2012). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

New Biopsy-Confirmed Nonmelanoma Skin Cancer (NMSC) Lesions Per Subject Per Year (time frame: up to 24 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00129961, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 11 Apr 2012.

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