Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation

Josep M Cruzado

Status and phase: Completed; Phase 4

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Cinacalcet; Procedure: Subtotal parathyroidectomy

Study type: Interventional

Funder types: Other

Identifiers

NCT01178450

01PTHi

2008-007017-76 (EudraCT Number)

Details and patient eligibility

About

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.

Full description

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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.

Enrollment: 30 patients

Sex: All

Ages: 18 to 80 years old

Volunteers: No Healthy Volunteers

Inclusion criteria

• Functioning renal transplant, GFR ≥ 30 ml / min
• Time post-transplant> 6 months
• PTHi>15pmol/L
• Calcium ≥2.63 mmol/L con phosphatemia ≤1.2 mmol/L
• Cervical scintigraphy
• Signed informed consent

Exclusion criteria

• Contraindication to surgery

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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30 participants in 2 patient groups

Subtotal parathyroidectomy

Active Comparator group

Description:

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

Treatment:

Procedure: Subtotal parathyroidectomy

Cinacalcet

Experimental group

Description:

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

Treatment:

Drug: Cinacalcet