Transplant Trial Watch

Effects of the strict control of blood pressure in pediatric renal transplant recipients-ESCORT trial.

Seeman T, Vondrak K, Dusek J.

Pediatr Transplant. 2018; [record in progress].


Aims
To determine the efficacy and safety of strict blood pressure (BP) control on the progression of allograft dysfunction in children after kidney transplantation (KTx).

Interventions
Patients were randomised to either the standard BP group (STAND, target 24‐hour mean arterial pressure [MAP] 50‐95th percentile, n = 11) or the intensified BP group (INTENS, target 24‐hour MAP <50th percentile, n = 12).

Participants
23 pediatric patients (age 3‐15.9 years, ≥1 year post KTx, no acute rejection in the previous 3 months, eGFR >15ml/min/1.73m2, 24‐hour MAP ≥50th percentile).

Outcomes
The primary endpoint was the annual reduction in eGFR (mL/min/1.73 m2/y). Secondary endpoints were changes in 24‐hour MAP, proteinuria, graft and patient survival, and safety. BP was measured in the renal clinic using oscillometric BP monitor (Omron M6, Omron Healthcare), eGFR and proteinuria (protein/creatinine ratio) were tested every month, and ambulatory 24‐hour blood pressure monitoring was carried out every 6 months. Treatment of BP was managed according to 24‐hour MAP levels.

Follow-up
3 years

CET Conclusions
The small ESCORT trial examined whether strict blood pressure control in paediatric kidney transplant recipients can slow down the progression of chronic allograft dysfunction. Patients who were at least 1 year posttransplant were randomised to standard blood pressure target (50th to 95th percentile of 24‐hour mean arterial pressure (MAP)) or an intensified blood pressure target (<50th percentile of 24‐hour MAP). No details of the randomisation were described and the authors stated that no power analysis was conducted as there are no previous studies on strict blood pressure control in paediatric or adult kidney transplant patients. Data were analysed according to intention to treat and all 23 participants were accounted for in the analysis. The annual reduction in eGFR did not differ significantly between groups in the intention to treat and per-protocol analyses. Of the secondary outcomes, only the change in 24-hour MAP was significantly different between groups.

Jadad score
2

Data analysis
Modified intention-to-treat analysis

Allocation concealment
No

Trial registration
None

Funding source
Non-industry funded