Transplant Trial Watch

Soluble CD30 and ELISA-detected human leukocyte antigen antibodies for the prediction of acute rejection in pediatric renal transplant recipients.

Billing H, Sander A, et al.

Transplant International. 2013; 26(3): 331-338


Aims
To monitor soluble CD30 and ELISA-detected human leukocyte antigen antibodies as biomarkers to predict biopsy proven acute rejection, in addition to investigating the effect of early steroid withdrawal on T-cell and B-cell reactivity during the first 6 months post-transplant, in pediatric renal allograft recipients.

Interventions
The immunosuppressive regimen included the administration of tacrolimus and mycophenolate mofetil (MMF) to both the control and steroid withdrawal groups. The steroid withdrawal group received the first dose of daclizumab 1.0mg/kg within 24 hours of reperfusion. The final dose of 1.0mg/kg was administered on day 14. The corticosteroids were administered as a bolus dose of 300-600 mg/m² i.v. on day 0, reduced through days 2-4 and discontinued on day 5. This was the same for the control group. Corticosteroid doses were reduced on days 43-183 at the discretion of the investigator.

Participants
28 pediatric renal allograft recipients.

Outcomes
Biopsy proven acute rejection (BPAR) and the concentration of sCD30, anti-HLA class 1 and 2 antibody reactivities and eGFR.

Follow-up
2 years.

CET Conclusions
This analysis was done as part of the un-blinded RCT “TWIST” study. Soluble CD30 (40U/ml) was predictive of subsequent rejection at 14 days post-op, but not at any other time-point. Anti-HLA reactivities especially Class II, were related to rejection, the withdrawal of steroids was associated with higher levels of soluble CD30, as well as numerically more rejection episodes.

Jadad score
3

Data analysis
Strict intention-to-treat analysis

Allocation concealment
Yes

Quality notes
Scores based on Grenda R, Watson A, et al. A randomized trial to assess the impact of early steroid withdrawal on growth in pediatric renal transplantation: the TWIST study. American Journal of Transplantation 2012; 10: 828.

Trial registration
Clinical Trial No: FG-506-02-43 (TWIST trial)

Funding source
Industry funded