A Randomized Study Comparing Parathyroidectomy Versus Cinacalcet to Treat Hypercalcemia in Kidney Allograft Recipients With Persistent Hyperparathyroidism
J. Cruzado,1 V. Torregrosa,5 R. Mast,3 A. García-Barrasa,2 O. Bestard,1 E. Melilli,1 J. Francos,2 J. Torras,1 C. Polo,1 C. Gómez-Vaquero,4 J. Grinyó,1 P. Moreno.2
1Nephrology, Hospital de Bellvitge, Barcelona, Spain
2Surgery, Hospital de Bellvitge, Barcelona, Spain
3Radiology, Hospital de Bellvitge, Barcelona, Spain
4Rheumatology, Hospital de Bellvitge, Barcelona, Spain
5Nephrology, Hospital Clínic, Barcelona, Spain.
Meeting: 2015 American Transplant Congress
Abstract number: 389
Keywords: Hyperparathyroidism, Kidney transplantation
Session Information
Session Name: Concurrent Session: Kidney: Pregnancy, Metabolic Complications, Malignancy
Session Type: Concurrent Session
Date: Tuesday, May 5, 2015
Session Time: 2:15pm-3:45pm
Presentation Time: 3:15pm-3:27pm
Location: Room 119-B
Purpose: Cinacalcet corrects hypercalcemia and hypophosphatemia in patients with persistent hyperparathyroidism (HPT) after kidney transplantation (KT). This study (NCT011178450) was designed to evaluate whether subtotal parathyroidectomy (PTX, standard of care) was superior to cinacalcet (CIN) to control HPT after KT.
Methods: This is a 12-M, prospective, multicenter, randomized study. Kidney allograft recipients were included if time after transplantation is > 6 m, eGFR > 30 ml/min, iPTH> 15 pmol/L, serum calcium (sCa) > 2.63 mmol/L, serum phosphate (sP) <1.2 mmol/L. The primary end point was achievement of normocalcemia. Secondary end points were iPTH, sP, eGFR, bone mineral density and vascular calcification.
Results: A total of 30 patients were randomized (PTX, N=15; CIN, N=15). Baseline characteristics were similar between groups, including serum calcidiol level (44±26 in CIN vs 41±15 in PTX) and eGFR (57±11 in CIN, 56±15 in PTX). By ITT analysis both treatments were able to correct hypercalcemia although only PTX induced iPTH and sP normalization.
CIN, N=15 | PTX, N=15 | P value | |
---|---|---|---|
iPTH Baseline | 25±12 | 37±38 | 0.22 |
iPTH 3m | 18±7 | 9±10 | 0.02 |
iPTH 6m | 20±9 | 7±6 | 0.001 |
iPTH 12 m | 22±11 | 6±5 | 0.001 |
sCa Baseline | 2.72±0.1 | 2.78±0.2 | 0.3 |
sCa 3m | 2.42±0.2 | 2.28±0.2 | 0.07 |
sCa 6m | 2.42±0.2 | 2.26±0.2 | 0.04 |
sCa 12m | 2.37±0.2 | 2.22±0.2 | 0.06 |
sP Baseline | 0.92±0.2 | 0.93±0.2 | 0.9 |
sP 3m | 1.1±0.1 | 1.3±0.2 | 0.01 |
sP 6m | 1.0±0.2 | 1.3±0.2 | 0.001 |
sP 12m | 1.1±0.1 | 1.3±0.3 | 0.01 |
Moreover, PTX was associated with better preservation of renal function (12-M δ eGFR was -9 ml/min in CIN vs -4 ml/min in PTX). Safety data was similar between groups.
Conclusion: Subtotal parathyroidectomy was superior to cinacalcet to control HPT after KT
To cite this abstract in AMA style:
Cruzado J, Torregrosa V, Mast R, García-Barrasa A, Bestard O, Melilli E, Francos J, Torras J, Polo C, Gómez-Vaquero C, Grinyó J, Moreno P. A Randomized Study Comparing Parathyroidectomy Versus Cinacalcet to Treat Hypercalcemia in Kidney Allograft Recipients With Persistent Hyperparathyroidism [abstract]. Am J Transplant. 2015; 15 (suppl 3). https://atcmeetingabstracts.com/abstract/a-randomized-study-comparing-parathyroidectomy-versus-cinacalcet-to-treat-hypercalcemia-in-kidney-allograft-recipients-with-persistent-hyperparathyroidism/. Accessed November 21, 2024.« Back to 2015 American Transplant Congress