Transplant Trial Watch

Single-dose rATG Induction at Renal Transplantation: Superior Renal Function and Glucoregulation with Less Hypomagnesemia

Stevens RB, Lane JT, et al.

Clinical Transplantation, 26(1): 123-132, 2012.


Aims
To compare the effect of single dose with divided doses of rabbit anti-thymocyte globulin (rATG) induction therapy on renal function and glucose regulation in kidney transplant patients.

Interventions
Single dose of 6 mg/kg rATG versus four doses of rATG given every other day at 1.5 mg/kg per dose. All patients received tacrolimus and sirolimus maintenance immunosuppression regimen.

Participants
98 renal transplant patients without diabetes.

Outcomes
Renal function measured as glomerular filtration rate, serum creatinine, glucose regulation, fasting blood glucose, rate of new-onset diabetes after transplantation and serum Mg++. Factors in cox regression models were recipient age, body mass index, gender, donor type, rATG dose group, and tacrolimus and sirolimus trough levels.

Follow-up
6 months

CET Conclusions
This is a post hoc analysis in a randomised controlled trial of a single dose rapid rATG induction versus 4 doses of rATG for induction with respect to glucose regulation and early renal function both of which seemed to be improved more by the large single dose of rATG given at the time of transplantation. There was also less hypomagnesaemia in the patients receiving the single dose rATG.

Jadad score
3

Data analysis
Modified intention-to-treat analysis

Allocation concealment
Yes

Quality notes
This is a sub-analysis of a previous publication of the same RCT: Stevens RB, Mercer DF, Grant WJ et al. Randomized trial of single-dose versus divided-dose rabbit anti-thymocyte globulin induction in renal transplantation: an interim report. Transplantation 2008: 85: 1391. The methodological quality assessment was based on the previous publication.

Trial registration
NCT00556933 (ClinicalTrials.gov)

Funding source
Industry & non-industry funded