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

Secondary Hyperparathyroidism Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01178450
• Other study ID #: 01PTHi
• Secondary ID: 2008-007017-76
• Status: Completed
• Phase: Phase 4
• First received: April 19, 2010
• Last updated: April 27, 2015
• Start date: January 2010
• Est. completion date: September 2014

Study information

• Verified date: April 2015
• Source: Hospital Universitari de Bellvitge
• Contact: n/a
• Is FDA regulated: No
• Health authority: Spain: Spanish Agency of Medicines
• Study type: Interventional

Clinical Trial 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.

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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

Recruitment information / eligibility

• Status: Completed
• Enrollment: 30
• Est. completion date: September 2014
• Est. primary completion date: September 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 80 Years

Eligibility

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

Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Hyperparathyroidism
• Hyperparathyroidism, Secondary
• Neoplasm Metastasis
• Secondary Hyperparathyroidism

Intervention

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

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

Locations

Country	Name	City	State
Spain	Hospital Clinic de Barcelona	Barcelona
Spain	Hospital Universitari de Bellvitge	L'Hospitalet de Llobregat	Barcelone

Sponsors (1)

Lead Sponsor	Collaborator
Josep M Cruzado

Country where clinical trial is conducted

Spain, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in blood calcium levels	Change from baseline in blood calcium levels at 12 months.	12 months	No
Secondary	Change in parathyrin blood levels	Change from baseline in parathyrin blood levels at 12 months.	12 months	No
Secondary	Patient and graft survival	Patient and graft survival between inclusion and month 12.	12 months	Yes
Secondary	Economic evaluation of interventions measured by money spend in it.	Comparison of economic evaluations of both interventions between inclusion and month 12.	12 months	No
Secondary	Estimated glomerular filtration rate.	Change from baseline in glomerular filtration rate at 12 months.	12 months	Yes
Secondary	Change in blood calcium levels	Change from baseline in blood calcium levels at 3 months.	3 months	No
Secondary	Change in blood calcium levels	Change from baseline in blood calcium levels at 6 months.	6 months	No
Secondary	Change in parathyrin blood levels	Change from baseline parathyrin blood levels at 3 months.	3 months	No
Secondary	Change in parathyrin blood levels	Change from baseline parathyrin blood levels at 6 months.	6 months	No