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

Status

Completed

Phases

Phase 4

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT01178450

Enrollment

Registered

2010-08-10

Start date

2010-01-31

Completion date

2014-09-30

Last updated

2015-04-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

Keywords

Renal transplant, Hypercalcemia

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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

Interventions

PROCEDURESubtotal 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

DRUGCinacalcet

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

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to 80 Years

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

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Change in parathyrin blood levels	12 months	Change from baseline in parathyrin blood levels at 12 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	3 months	Change from baseline in blood calcium levels at 3 months.

Countries

Spain

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026