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

A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation

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.

Study Overview

• Status: Completed
• Conditions: Secondary Hyperparathyroidism
• Intervention / Treatment: Procedure: Subtotal parathyroidectomy; Drug: Cinacalcet

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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 Type: Interventional
• Enrollment (Actual): 30
• Phase: Phase 4

Contacts and Locations

Study Locations

• Spain
  • Barcelona, Spain, 08036
    • Hospital Clinic de Barcelona
  • Barcelone
    • L'Hospitalet de Llobregat, Barcelone, Spain, 08907
      • Hospital Universitari de Bellvitge

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 80 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

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 Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: Randomized
• Interventional Model: Parallel Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Active Comparator: 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	Procedure: 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; Other Names: Parathyroidectomy
Experimental: 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	Drug: 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in blood calcium levels	Change from baseline in blood calcium levels at 12 months.	12 months

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
Change in parathyrin blood levels	Change from baseline in parathyrin blood levels at 12 months.	12 months
Patient and graft survival	Patient and graft survival between inclusion and month 12.	12 months
Economic evaluation of interventions measured by money spend in it.	Comparison of economic evaluations of both interventions between inclusion and month 12.	12 months
Estimated glomerular filtration rate.	Change from baseline in glomerular filtration rate at 12 months.	12 months
Change in blood calcium levels	Change from baseline in blood calcium levels at 3 months.	3 months
Change in blood calcium levels	Change from baseline in blood calcium levels at 6 months.	6 months
Change in parathyrin blood levels	Change from baseline parathyrin blood levels at 3 months.	3 months
Change in parathyrin blood levels	Change from baseline parathyrin blood levels at 6 months.	6 months

Collaborators and Investigators

• Sponsor: Josep M Cruzado
• Investigators: Study Chair: Josep M Cruzado, MD, Nephrology Department. Hospital Universitari de Bellvitge; Study Chair: Pablo Moreno, MD, Surgery Department. Hospital Universitari de Bellvitge

Study record dates

Study Major Dates

• Study Start: January 1, 2010
• Primary Completion (Actual): September 1, 2014
• Study Completion (Actual): September 1, 2014

Study Registration Dates

• First Submitted: April 19, 2010
• First Submitted That Met QC Criteria: August 9, 2010
• First Posted (Estimate): August 10, 2010

Study Record Updates

• Last Update Posted (Estimate): April 28, 2015
• Last Update Submitted That Met QC Criteria: April 27, 2015
• Last Verified: April 1, 2015

More Information

Terms related to this study

• Keywords: Hypercalcemia; Renal transplant
• Additional Relevant MeSH Terms: Pathologic Processes; Neoplasms; Endocrine System Diseases; Parathyroid Diseases; Neoplastic Processes; Hyperparathyroidism; Neoplasm Metastasis; Hyperparathyroidism, Secondary; Physiological Effects of Drugs; Hormones, Hormone Substitutes, and Hormone Antagonists; Hormone Antagonists; Calcium-Regulating Hormones and Agents; Calcimimetic Agents; Cinacalcet
• Other Study ID Numbers: 01PTHi; 2008-007017-76 (EudraCT Number)