The use of cinacalcet after pediatric renal transplantation: an international CERTAIN Registry analysis

Pediatr Nephrol. 2020 Sep;35(9):1707-1718. doi: 10.1007/s00467-020-04558-8. Epub 2020 May 4.

Abstract

Background: Secondary hyperparathyroidism (SHPT) may persist after renal transplantation (RTx), inducing hypophosphatemia and hypercalcemia that precludes the use of vitamin D analogs. The calcimimetic cinacalcet improved plasma calcium and parathyroid hormone (PTH) levels in randomized controlled trials in adults after RTx, but pediatric data are scarce.

Methods: In this retrospective study, we analyzed 20 pediatric patients from the Cooperative European Paediatric Renal TransplAnt Initiative (CERTAIN) Registry who received cinacalcet after RTx. The results are presented as median and interquartile range (25th-75th percentile).

Results: At 13.7 (11.0-16.5) years of age, 20 pediatric patients received a renal allograft. Cinacalcet was introduced at 0.4 (0.3-2.7) years post-transplant at an estimated glomerular filtration rate (eGFR) of 50 (34-66) mL/min/1.73 m2, plasma calcium of 2.58 (2.39-2.71) mmol/L, age-standardized (z score) phosphate of - 1.7 (- 2.7-- 0.4), and PTH of 136 (95-236) ng/L. The starting dose of cinacalcet was 0.5 (0.3-0.8) mg/kg per day, with a maximum dose of 1.1 (0.5-1.3) mg/kg per day. With a follow-up of 3.0 (1.5-3.6) years on cinacalcet therapy, eGFR remained stable; PTH levels decreased to 66 (56-124) ng/L at the last follow-up (p = 0.015). One patient displayed hypocalcemia (1.8 mmol/L). Cinacalcet was withdrawn in three patients (hypocalcemia, parathyroidectomy, incompliance). Nephrocalcinosis of the graft was not reported.

Conclusions: This pilot study suggests that cinacalcet as off-label therapy for SHPT after pediatric RTx is efficacious in controlling post-transplant SHPT with acceptable tolerability. Continuing cinacalcet even with normal PTH can lead to dangerous life-threatening hypocalcemia. Therefore, at each subsequent visit, the need to continue cinacalcet must be assessed.

Keywords: Calcimimetics; Children; Renal transplantation; Secondary hyperparathyroidism.

Publication types

  • Research Support, Non-U.S. Gov't

MeSH terms

  • Adolescent
  • Calcimimetic Agents / administration & dosage*
  • Calcimimetic Agents / adverse effects
  • Child
  • Cinacalcet / administration & dosage*
  • Cinacalcet / adverse effects
  • Dose-Response Relationship, Drug
  • Female
  • Humans
  • Hyperparathyroidism, Secondary / drug therapy*
  • Hyperparathyroidism, Secondary / etiology*
  • Kidney Failure, Chronic / complications*
  • Kidney Failure, Chronic / surgery
  • Kidney Transplantation
  • Male
  • Off-Label Use
  • Pilot Projects
  • Registries
  • Retrospective Studies
  • Transplant Recipients

Substances

  • Calcimimetic Agents
  • Cinacalcet