Immunosuppression dose reduction to prevent development of aggressive skin cancer after kidney transplantation

Prospective Randomized Controlled Trial of Monitored Immunosuppression Dose Reduction for Secondary Prevention of Squamous Cell Carcinoma of the Skin in Kidney Transplant Recipients

Status

Not yet recruiting

Phases

Unknown

Study type

Interventional

Source

ANZCTR

Registry ID

ACTRN12614000864628

Enrollment

Registered

2014-08-12

Start date

2014-09-01

Completion date

2016-09-01

Last updated

2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Brief summary

This study will determine whether reducing the doses of anti-rejection drugs is effective in preventing squamous cell carcinoma of the skin in kidney transplant recipients. Who is it for? You may be eligible to join this study if you aged 18 years or above, are a kidney transplant recipient with a previous squamous cell carcinoma of the skin. Study details Participants in this study are randomly allocated (by chance) to one of two groups. Participants in one group will have monitored dose reduction in immunosuppression, whilst participants in the other group will remain on their current drug regimen. Participants will be follow-up for 60 months, in order to determine how many new squamous cell carcinomas develop and whether they are aggressive. There are several test of the immune system to make sure the risk of acute or chronic rejection is very low but your kidney function will be followed for up to 60 months to make sure the dose reduction is safe over the long term.

Interventions

Reduction in immunosuppression: Tacrolimus, Cyclosporin and Mycophenolate will be reduced on average by 25% based on drug exposure profiles. All these medications are dosed twice a day. The dose reduction will occur at a single time point and the drug exposure profile measured 2 weeks later to determine whether subsequent reduction is required. If required again drug exposure will be checked two weeks later.

Study design

Allocation

Randomised controlled trial

Intervention model

Parallel

Primary purpose

Prevention

Masking

Open (masking not used)

Eligibility

Sex/Gender

All

Age

18 Years to 85 Years

Healthy volunteers

Inclusion criteria

Kidney transplant recipients with a previous squamous cell carcinoma of the skin High levels of Regulatory T cells in peripheral blood Low levels of allo reactive T cells measured by ELISPOT Absence of donor specific allo antibodies

Exclusion criteria

Presence of a donor specific antibody High levels of allo reactive T cells in peripheral circulation Low levels of Regulatory T cells in blood

Outcome results