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| ID | Type | Description | Link |
|---|---|---|---|
| 2008-007017-76 | EudraCT Number |
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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.
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 The subtotal parathyroidectomy is the standard treatment, although currently has been replaced by the calcimimetic cinacalcet.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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Subtotal parathyroidectomy | Active Comparator | 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 |
|
| Cinacalcet | Experimental | 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 |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Subtotal parathyroidectomy | Procedure | 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Change in blood calcium levels | Change from baseline in blood calcium levels at 12 months. | 12 months |
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Josep M Cruzado, MD | Nephrology Department. Hospital Universitari de Bellvitge | Study Chair |
| Pablo Moreno, MD | Surgery Department. Hospital Universitari de Bellvitge | Study Chair |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Hospital Clinic de Barcelona | Barcelona | Barcelona | 08036 | Spain | ||
| Hospital Universitari de Bellvitge |
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| ID | Term |
|---|---|
| D006962 | Hyperparathyroidism, Secondary |
| D006934 | Hypercalcemia |
| ID | Term |
|---|---|
| D006961 | Hyperparathyroidism |
| D010279 | Parathyroid Diseases |
| D004700 | Endocrine System Diseases |
| D002128 | Calcium Metabolism Disorders |
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| ID | Term |
|---|---|
| D016105 | Parathyroidectomy |
| D000069449 | Cinacalcet |
| ID | Term |
|---|---|
| D013507 | Endocrine Surgical Procedures |
| D013514 | Surgical Procedures, Operative |
| D009281 | Naphthalenes |
| D011084 | Polycyclic Aromatic Hydrocarbons |
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|
| Cinacalcet | Drug | 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 |
|
| 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 |
| L'Hospitalet de Llobregat |
| Barcelone |
| 08907 |
| Spain |
| D008659 | Metabolic Diseases |
| D009750 | Nutritional and Metabolic Diseases |
| D014883 | Water-Electrolyte Imbalance |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
| D006838 | Hydrocarbons |
| D009930 | Organic Chemicals |
| D011083 | Polycyclic Compounds |