Phase 4 Kidney Cancer Trial, Completed NCT00129961 Sponsor: Wyeth is now a wholly owned subsidiary of Pfizer Condition: Kidney Cancer
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Trial results

AI generated results summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

According to the results reported on ClinicalTrials.gov, this trial enrolled 86 people in total — 39 in a group receiving a sirolimus (SRL) based medication regimen and 47 in a group receiving a calcineurin inhibitor (CNI) based regimen. Both groups were already transplant recipients who had previously developed non-melanoma skin cancers (NMSCs) — a category that includes two common skin cancer types: squamous cell carcinoma (SCC) and basal cell carcinoma (BCC). The trial was measuring whether the type of anti-rejection medication a person took was linked to differences in how often new skin cancers appeared. Around half of participants in each group did not complete the study (19 in the SRL group and 23 in the CNI group). The reported data shows that the main thing being tracked — the rate of new, biopsy-confirmed (meaning confirmed by a tissue sample test) skin cancer lesions per person per year — was recorded as 1.31 in the sirolimus group and 2.48 in the CNI group. For the secondary measures, the reported data shows the average number of days until a first new skin cancer lesion was confirmed was 380 days in the sirolimus group and 163 days in the CNI group. The reported data also shows that 17 out of 39 participants in the sirolimus group had no new lesions during the study, compared with 9 out of 47 in the CNI group. The rate of skin cancers that came back at a previously treated spot was reported as 0.107 lesions per person per year in the sirolimus group and 0.134 in the CNI group. The breakdown between SCC and BCC lesion types was broadly similar between the two groups (around 67–69% SCC and 31–33% BCC). These are the results as reported to ClinicalTrials.gov. They are not medical advice — always discuss what they mean for you with your doctor.

These are the results as reported to ClinicalTrials.gov, not medical advice. Verify independently with the trial site and discuss what they mean for you with your doctor.

Phase 4 Kidney Cancer Trial, Completed

NCT00129961
Completed Phase 4 🇦🇺 Australian site

Who may be able to join

AI generated eligibility summary. Written by an AI model from the official source data and checked on a sample basis. It can contain mistakes, so confirm anything important against the original source. How we use AI

"Who might be able to join this trial:

  • You received a kidney transplant at least 1 year ago
  • Your transplanted kidney is working reasonably well, with good kidney function levels and only a small amount of protein in your urine (confirm with trial site for specific measurements)
  • You are currently taking a stable combination of anti-rejection medications based on either cyclosporine or tacrolimus
  • You have been diagnosed with a non-melanoma skin cancer (such as basal cell or squamous cell carcinoma) within the last 3 years

Who may not be able to join:

  • You have been diagnosed with any other type of cancer (other than non-melanoma skin cancer) within the last 3 years
  • Your non-melanoma skin cancer has spread to other parts of your body, or you have had more than 20 non-melanoma skin cancer lesions in the past 12 months
  • You have received more than one organ transplant

Important: Always verify eligibility with the trial site directly before applying."

Based on publicly available eligibility criteria from ClinicalTrials.gov. Verify directly with the trial site before acting. This is not medical advice.

This is a simplified plain English summary of the eligibility criteria. Full criteria are set by the trial investigators and may include additional requirements not shown here. Never self-exclude from a trial based on this summary. Contact the trial site directly to confirm your eligibility.
Last synced 22 July 2026
Phase 4 trials study a drug that has already been approved, monitoring long-term safety and effectiveness in real-world use.

Contact this trial

Principal Investigator: Medical Monitor, Wyeth is now a wholly owned subsidiary of Pfizer

Australian sites

, Camperdown, New South Wales
, Wooloongabba, Queensland
, Woodville, South Australia
, Adelaide,
, Clayton,
, Herston,
, Parkville,
, Randwick,
, Westmead,

Contact details sourced from ClinicalTrials.gov. Verify directly with the trial site before attending.

GP referral letter

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Trial details

Status
Completed
Phase
Phase 4
Sponsor
Wyeth is now a wholly owned subsidiary of Pfizer
Registry
ClinicalTrials.gov
Start date
1 August 2005
Est. completion
1 January 2009

Where this trial is recruiting

🇦🇺 Australia 🇨🇦 Canada 🇳🇿 New Zealand 🇺🇸 United States

9 site(s) in Australia. Confirm current status and contact details directly with the trial site.

Primary endpoints

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

Can't join this trial?

Expanded access pathways

If this trial is not available to you, other access pathways may exist. In Australia, the TGA Special Access Scheme allows access to unapproved therapeutic goods for individual patients.

TGA Special Access Scheme information

Find other recruiting trials on ClinicalTrials.gov

Data last synced from ClinicalTrials.gov: 22 July 2026. Trial status can change. Always verify current status directly with the trial site before making any decision.

Trial recruitment status can change without notice between our nightly data updates. Always contact the trial site directly to confirm current recruitment status before making any decisions or travel arrangements.

View original record on ClinicalTrials.gov