Transplant Trial Watch

Steroid withdrawal improves blood pressure control and nocturnal dipping in pediatric renal transplant recipients: analysis of a prospective, randomized, controlled trial.

Hocker B, Weber LT, et al.

Pediatric Nephrology, 2018; [record in progress].


Aims
An RCT substudy to investigate the impact of steroid withdrawal on blood pressure control and nocturnal blood pressure dipping in pediatric renal transplant recipients.

Interventions
Late steroid (prednisone) withdrawal (≥1 year posttransplant) was compared with continuous steroid treatment under cyclosporine (CsA)- and mycophenolate mofetil (MMF)-based immunosuppression. Blood pressure was measured using ambulatory blood pressure monitoring (ABPM) over 24 hour monitoring periods in conjunction with a diary of events.

Participants
28 pediatric renal allograft recipients (first or second transplant; aged <18 years; low immunologic risk; no acute rejection episode within the last 6 months before study entry) with ABPM data (≥40 recordings, including ≥8 nighttime readings).

Outcomes
Daytime and nighttime blood pressure by ABPM at baseline and Month 15. A hypertension score (based on blood pressure level plus number of antihypertensive treatments) was calculated at baseline and Month 15.

Follow-up
15 months (equivalent to 12 months after steroid withdrawal)

CET Conclusions
This manuscript reports a secondary analysis of a randomized trial of steroid withdrawal in pediatric renal transplant recipients. The authors report significantly lower incidence of hypertension, lower use of antihypertensive drugs and restoration of the normal circadian rhythm in the steroid withdrawal group. The results are impressive, suggesting a significant benefit which may have an impact on long-term cardiovascular risk. There are some caveats – the sample size is very small (28 patients) and a subset of just 2/3 of the originally recruited patients, leaving the possibility of recruitment bias. The hypertension score used is not validated, and the original study was performed nearly 10 years ago, so the relevance to current-day practice is uncertain.

Jadad score
3

Data analysis
Available case analysis

Allocation concealment
Yes

Trial registration
ClinicalTrials.gov - NCT00309218

Funding source
Industry funded