A Randomized Study Comparing Parathyroidectomy with Cinacalcet for Treating Hypercalcemia in Kidney Allograft Recipients with Hyperparathyroidism

Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplant. We designed this 12-month, prospective, multicenter, open-label, randomized study to evaluate whether subtotal parathyroidectomy is more effective than cinacalcet for controlling hypercalcemia caused by persiste...

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Bibliographic Details
Published in:Journal of the American Society of Nephrology 2016-08, Vol.27 (8), p.2487-2494
Main Authors: Cruzado, Josep M, Moreno, Pablo, Torregrosa, José V, Taco, Omar, Mast, Richard, Gómez-Vaquero, Carmen, Polo, Carolina, Revuelta, Ignacio, Francos, José, Torras, Joan, García-Barrasa, Arantxa, Bestard, Oriol, Grinyó, Josep M
Format: Article
Language:English
Subjects:
Calci en l'organisme
Calcimimetic Agents - therapeutic use
Calcium in the body
Cinacalcet Hydrochloride - therapeutic use
Clinical Research
Female
Hiperparatiroïdisme
Humans
Hypercalcemia - drug therapy
Hypercalcemia - etiology
Hypercalcemia - surgery
Hyperparathyroidism
Hyperparathyroidism, Secondary - complications
Hyperparathyroidism, Secondary - drug therapy
Hyperparathyroidism, Secondary - surgery
Kidney
Kidney Transplantation
Male
Middle Aged
Parathyroidectomy
Paratiroïdectomia
Postoperative Complications - drug therapy
Postoperative Complications - surgery
Prospective Studies
Ronyó
Trasplantament renal
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Summary:Tertiary hyperparathyroidism is a common cause of hypercalcemia after kidney transplant. We designed this 12-month, prospective, multicenter, open-label, randomized study to evaluate whether subtotal parathyroidectomy is more effective than cinacalcet for controlling hypercalcemia caused by persistent hyperparathyroidism after kidney transplant. Kidney allograft recipients with hypercalcemia and elevated intact parathyroid hormone (iPTH) concentration were eligible if they had received a transplant ≥6 months before the study and had an eGFR>30 ml/min per 1.73 m(2) The primary end point was the proportion of patients with normocalcemia at 12 months. Secondary end points were serum iPTH concentration, serum phosphate concentration, bone mineral density, vascular calcification, renal function, patient and graft survival, and economic cost. In total, 30 patients were randomized to receive cinacalcet (n=15) or subtotal parathyroidectomy (n=15). At 12 months, ten of 15 patients in the cinacalcet group and 15 of 15 patients in the parathyroidectomy group (P=0.04) achieved normocalcemia. Normalization of serum phosphate concentration occurred in almost all patients. Subtotal parathyroidectomy induced greater reduction of iPTH and associated with a significant increase in femoral neck bone mineral density; vascular calcification remained unchanged in both groups. The most frequent adverse events were digestive intolerance in the cinacalcet group and hypocalcemia in the parathyroidectomy group. Surgery would be more cost effective than cinacalcet if cinacalcet duration reached 14 months. All patients were alive with a functioning graft at the end of follow-up. In conclusion, subtotal parathyroidectomy was superior to cinacalcet in controlling hypercalcemia in these patients with kidney transplants and persistent hyperparathyroidism.
ISSN:1046-6673
1533-3450
DOI:10.1681/ASN.2015060622