A randomized, prospective comparison of transition to sirolimus-based CNI-minimization or withdrawal in African American kidney transplant recipients.
Fleming JN, Taber DJ, et al.Clinical Transplantation 2016; 30(5): 528-533.
Aims
To compare sirolimus-based calcineurin inhibitor (CNI) withdrawal and minimization transition regimens in adult African American kidney transplant recipients.
Interventions
Participants were randomized between six and 24 weeks post-transplant to either sirolimus with mycophenolate mofetil and corticosteroids (CNI-withdrawal), versus sirolimus with low-exposure tacrolimus and corticosteroids (CNI-minimization).
Participants
40 patients of African American ethnicity with stable graft function aged ≥ 18 years receiving their first or second deceased donor or living donor renal transplant.
Outcomes
The primary measured outcome was estimated glomerular filtration rate. Secondary measured outcomes included biopsy-proven acute rejection, graft and patient survival, serum creatinine, cystatin C concentrations, and toxicities.
Follow-up
1 year
CET Conclusions
In this randomised pilot study African American recipients with stable function, who were receiving tacrolimus, mycophenolate and steroids, were randomised 2 to 3 months after transplantation either to withdrawal of tacrolimus and replacement with sirolimus, or to minimisation of the tacrolimus dosage. The two cohorts were quite small 23 and 17 respectively, and the results are difficult to interpret as there was such a high discontinuation rate in patients in both arms. Thus, although one year renal function (eGFR, the primary outcome) was certainly better in the tacrolimus withdrawal arm in contrast to the tacrolimus minimisation arm, the numbers remain relatively small. This possibly represents a possible approach to the problem of declining renal function on CNI immunosuppressive agents in the African American recipient but this data is no more than suggestive and would require further exploration in larger prospective randomised trials than was the case in this small pilot study.
Data analysis
Per protocol analysis
Trial registration
Clinicaltrials.gov - NCT01005706