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

Phase 4

Completed

• Conditions: Secondary Hyperparathyroidism
• Interventions: Procedure: Subtotal parathyroidectomy; Drug: Cinacalcet

• Registration Number: NCT01178450
• Lead Sponsor: Josep M Cruzado

Brief Summary

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.

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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

Study Timeline

• Study Start: 2010-01
• Study First Submitted: 2010-04-19
• Study First Submitted QC: 2010-08-09
• Study First Posted: 2010-08-10
• Primary Completion: 2014-09
• Study Completion: 2014-09
• Status Verified: 2015-04
• Last Update Submitted: 2015-04-27
• Last Update Posted: 2015-04-28

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 30

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

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Subtotal parathyroidectomy	Subtotal parathyroidectomy	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	Cinacalcet	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

Primary Outcome Measures

Name	Time	Method
Change in blood calcium levels	12 months	Change from baseline in blood calcium levels at 12 months.

Secondary Outcome Measures

Name	Time	Method
Change in parathyrin blood levels	6 months	Change from baseline parathyrin blood levels at 6 months.
Patient and graft survival	12 months	Patient and graft survival between inclusion and month 12.
Economic evaluation of interventions measured by money spend in it.	12 months	Comparison of economic evaluations of both interventions between inclusion and month 12.
Estimated glomerular filtration rate.	12 months	Change from baseline in glomerular filtration rate at 12 months.
Change in blood calcium levels	6 months	Change from baseline in blood calcium levels at 6 months.

Trial Locations

Locations (2)

Hospital Clinic de Barcelona; 🇪🇸 Barcelona, Spain

Hospital Universitari de Bellvitge; 🇪🇸 L'Hospitalet de Llobregat, Barcelone, Spain