Clinical trial NCT01178450: Parathyroidectomy vs Cinacalcet in the Treatment of Secondary Hyperparathyroidism Post Renal Transplantation
Official title: A Prospective, Randomized Trial to Compare Subtotal Parathyroidectomy Versus Cinacalcet in the Treatment of Persistent Secondary Hyperparathyroidism Post Renal Transplantation
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Secondary Hyperparathyroidism
Keywords: Renal transplant
Hypercalcemia
Lead sponsor: Hospital Universitari de Bellvitge
Sponsor class: OTHER
First posted: 2010-08-10
Enrollment: 30
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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

Eligibility criteria: 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

Primary outcomes:
measure: Change in blood calcium levels
timeFrame: 12 months
Secondary outcomes:
measure: Change in parathyrin blood levels
timeFrame: 12 months
measure: Patient and graft survival
timeFrame: 12 months
measure: Economic evaluation of interventions measured by money spend in it.
timeFrame: 12 months
measure: Estimated glomerular filtration rate.
timeFrame: 12 months
measure: Change in blood calcium levels
timeFrame: 3 months
measure: Change in blood calcium levels
timeFrame: 6 months
measure: Change in parathyrin blood levels
timeFrame: 3 months
measure: Change in parathyrin blood levels
timeFrame: 6 months
Other outcomes:
Locations:
city: L'Hospitalet de Llobregat
country: Spain
facility: Hospital Universitari de Bellvitge
state: Barcelone
city: Barcelona
country: Spain
facility: Hospital Clinic de Barcelona
Study officials:
affiliation: Nephrology Department. Hospital Universitari de Bellvitge
name: Josep M Cruzado, MD
role: STUDY_CHAIR
affiliation: Surgery Department. Hospital Universitari de Bellvitge
name: Pablo Moreno, MD
role: STUDY_CHAIR
References: