Transplant Trial Watch

Rabbit-ATG or basiliximab induction for rapid steroid withdrawal after renal transplantation (Harmony): an open-label, multicentre, randomised controlled trial.

Thomusch O, Wiesener M, et al.

Lancet 2017; 388(10063): 3006-3016.


Aims
To examine the efficacy and safety parameters of rapid steroid withdrawal after induction therapy with either rabbit antithymocyte globulin (rabbit ATG) or basiliximab in immunologically low-risk patients during the first year after kidney transplantation.

Interventions
Participants were randomly assigned to one of three study arms and received basiliximab induction with low-dose tacrolimus, mycophenolate mofetil, and steroid maintenance therapy. Those in Arm A (control group) continued with this regimen, while rapid corticosteroid withdrawal on day 8 (Arm B), and rapid corticosteroid withdrawal on day 8 after rabbit ATG (Arm C).

Participants
615 patients with a low immunological risk, scheduled to receive a single-organ renal transplant from either a living donor or a deceased donor, aged between 18-75 years.

Outcomes
The primary outcome measured was the incidence of biopsy-proven acute rejection (BPAR) within the first year after renal transplantation. Secondary outcomes included patient and graft survival, graft function, percentage of patients in which steroid-free immunosuppressive treatment was maintained after 12 months, incidence of posttransplantation diabetes, systolic and diastolic blood pressure, lipids, bodyweight, infections, incidence of malignancy, wound healing disorders, cataract formation, and osteoporosis.

Follow-up
12 months

CET Conclusions
This large multicentre study from Germany randomised low-risk kidney transplant recipients to three groups – Basiliximab induction with maintenance steroids, Basilixmab induction with early steroid withdrawal, or ATG induction with steroid withdrawal. All patients received standard immunosuppression with low-dose tacrolimus and 2g/day MMF. Two important observations are made; Firstly, BPAR rates did not differ between arms suggesting that in low-risk recipients, Basiliximab is as effective as ATG, even in the absence of maintenance steroids. Secondly, even the low doses of maintenance steroids used (2.5-5mg/day) significantly increased the risk of post-transplant diabetes. There were no differences in safety outcomes including infection or malignancy between arms. Power was reduced by a large number of drop-outs from the study, but there are no trends to suggest that a larger sample would have resulted in any different conclusions. Certainly it would appear that in a low-risk, predominantly Caucasian population, Basiliximab induction with early steroid withdrawal is a safe strategy.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT00724022

Funding source
Industry funded