The hypothesis of this study is that subtotal parathyroidectomy using minimally invasive surgery is superior to cinacalcet for the treatment of persistent secondary hyperparathyroidism (HPT) post renal transplant, with minimal morbidity and significantly reduces the cost of treatment post transplant.
Persistent hyperparathyroidism (HPT) with hypercalcemia is prevalent after transplant (affects up to 25% of patients) and negatively affects graft and patient outcome. The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet. Several studies guarantee that cinacalcet is effective in controlling hypercalcemia derived of persistent HPT after renal transplantation. However, maintenance treatment is need because hypercalcemia increases quickly after treatment is stopped. This fact makes increase a lot the cost of transplantation in these patients. The hypothesis of this study is that subtotal parathyroidectomy by minimally invasive surgery is superior to cinacalcet for treatment of persistent secondary HPT post renal transplant, with minimal morbidity and significantly reduces the cost of treatment after transplantation.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Enrollment
30
The procedure of choice is subtotal parathyroidectomy if the intraoperative biopsy confirms multiglandular disease and at least 3 glands are removed leaving a remanent of one normal gland
Cinacalcet is initiated at a dose of 30 mg per day PO, adjusting the dose monthly (up to 90 mg per day PO) to achieve normocalcemia
Hospital Clinic de Barcelona
Barcelona, Barcelona, Spain
Hospital Universitari de Bellvitge
L'Hospitalet de Llobregat, Barcelone, Spain
Change in blood calcium levels
Change from baseline in blood calcium levels at 12 months.
Time frame: 12 months
Change in parathyrin blood levels
Change from baseline in parathyrin blood levels at 12 months.
Time frame: 12 months
Patient and graft survival
Patient and graft survival between inclusion and month 12.
Time frame: 12 months
Economic evaluation of interventions measured by money spend in it.
Comparison of economic evaluations of both interventions between inclusion and month 12.
Time frame: 12 months
Estimated glomerular filtration rate.
Change from baseline in glomerular filtration rate at 12 months.
Time frame: 12 months
Change in blood calcium levels
Change from baseline in blood calcium levels at 3 months.
Time frame: 3 months
Change in blood calcium levels
Change from baseline in blood calcium levels at 6 months.
Time frame: 6 months
Change in parathyrin blood levels
Change from baseline parathyrin blood levels at 3 months.
Time frame: 3 months
Change in parathyrin blood levels
This platform is for informational purposes only and does not constitute medical advice. Always consult a qualified healthcare professional.
Change from baseline parathyrin blood levels at 6 months.
Time frame: 6 months