TY - JOUR
T1 - The use of cinacalcet after pediatric renal transplantation
T2 - an international CERTAIN Registry analysis
AU - Bernardor, Julie
AU - Schmitt, Claus Peter
AU - Oh, Jun
AU - Sellier-Leclerc, Anne Laure
AU - Büscher, Anja
AU - Dello Strologo, Luca
AU - Genc, Gurkan
AU - John, Ulrike
AU - Weitz, Marcus
AU - Zirngibl, Matthias
AU - Krupka, Kai
AU - Tönshoff, Burkhard
AU - Bacchetta, Justine
N1 - Funding Information:
Justine Bacchetta has been an investigator for the Amgen-sponsored trials on the use of cinacalcet in pediatric dialysis. Justine Bacchetta is the coordinator of the Amgen-sponsored international registry on the use of cinacalcet in pediatric dialysis, and the national principal investigator for the Amgen-sponsored trial on the use of etelcalcetide in pediatric dialysis. She received a research grant for experimental studies by Amgen. Claus Peter Schmitt received financial support from Amgen for investigator-initiated experimental research, a travel grant, and is national principal investigator for the Amgen-sponsored trial on the use of etelcalcetide in pediatric dialysis. No other relevant conflicts of interest are reported.
Publisher Copyright:
© 2020, IPNA.
PY - 2020/9/1
Y1 - 2020/9/1
N2 - 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.
AB - 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.
KW - Calcimimetics
KW - Children
KW - Renal transplantation
KW - Secondary hyperparathyroidism
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U2 - 10.1007/s00467-020-04558-8
DO - 10.1007/s00467-020-04558-8
M3 - Article
C2 - 32367310
AN - SCOPUS:85085095424
VL - 35
SP - 1707
EP - 1718
JO - Pediatric Nephrology
JF - Pediatric Nephrology
SN - 0931-041X
IS - 9
ER -