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

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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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

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

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Procedure: Subtotal parathyroidectomy
* Drug: Cinacalcet


Participation Criteria
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Eligibility Criteria
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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

Ages Eligible for Study
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Minimum Age: 18 Years
Maximum Age: 80 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

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


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: Subtotal parathyroidectomy<br>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<br>* 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<br>* Other names: Parathyroidectomy;|
| Experimental: Cinacalcet<br>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<br>* 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<br>|

What is the study measuring?
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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 | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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Renal transplant, Hypercalcemia