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

• Register: ANZCTR
• Last refreshed on: 13 January 2020
• Main ID: ACTRN12614000864628
• Date of registration: 12/08/2014
• Prospective Registration: Yes
• Primary sponsor: Robert Peter Carroll
• Public title: Immunosuppression dose reduction to prevent development of aggressive skin cancer after kidney transplantation
• Scientific title: Prospective Randomized Controlled Trial of Monitored Immunosuppression Dose Reduction for Secondary Prevention of Squamous Cell Carcinoma of the Skin in Kidney Transplant Recipients
• Date of first enrolment: 01/09/2014
• Target sample size: 98
• Recruitment status: Not yet recruiting
• URL: https://anzctr.org.au/ACTRN12614000864628.aspx
• Study type: Interventional
• Study design: Purpose: Prevention; Allocation: Randomised controlled trial; Masking: Open (masking not used);Assignment: Parallel;Type of endpoint: Safety/efficacy;
• Phase: Not Applicable

Countries of recruitment

Australia

Contacts

• Name: Dr Robert Peter Carroll

• Name: Dr Robert Peter Carroll

Key inclusion & exclusion criteria

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

Age minimum: 18 Years
Age maximum: 85 Years
Gender: Both males and females

Health Condition(s) or Problem(s) studied

Cancer - Non melanoma skin cancer

skin cancer;kidney transplantation;
skin cancer
kidney transplantation

Renal and Urogenital - Kidney disease

Intervention(s)

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.

Primary Outcome(s)

Time to the development of first new squamous cell carcinoma of the skin after randomisation[New cancer development within 12 months]

Secondary Outcome(s)

development of donor specific antibodies as measured in sera by solid phase assay ie Luminex platform.[within 1 year of randomisation]

Development of proteinuria >500 mg/l in those with pre- existing proteinuria >100mg/l. Development of >100mg proteinuria in those with undetectable proteinuria. All of these measurements are via standard laboratory assay of urinary protein and via spot urine specimens not timed 24 hour samples[upto 5 years post randomisation]

Acute rejection or chronic rejection after randomisation- according to standard histological grading systems of rejection that is Banff 2014 criteria[5 years post randomisation]

Proportion of new squamous cell carcinomas that develop with high risk features: poorly differentiated; >3mm thick;>6 mm thick;peri neural invasion[12 months]

worsening of renal function >20% in serum assay of creatinine[upto 5 years post randomization]

Secondary ID(s)

NIL

Source(s) of Monetary Support

Australian and New Zealand Society of Nephrology

Secondary Sponsor(s)

Royal Adelaide Hospital

Ethics review

Status: Not approved
Approval date:
Contact:

Royal Adelaide Hospital