Total parathyroidectomy (PTX) in patients with secondary hyperparathyroidism (HPT2) is a more effective treatment than the use of Calcimimetica.
ID
Bron
Verkorte titel
Aandoening
The use of Cinacalcet in secondary hyperparathyroidism and chronic renal failure
instead of Total parathyroidectomy
Ondersteuning
Hanzeplein 1a , Surgical department
s.kruijff@umcg.nl
Onderzoeksproduct en/of interventie
Uitkomstmaten
Primaire uitkomstmaten
PTH 3 months after the intervention
Achtergrond van het onderzoek
Secondary hyperparathyroidism (sHPT) is one of the most common abnormalities in patients with chronic kidney disease, and is characterized by parathyroid gland hyperplasia and increased plasma levels of parathyroid hormone (PTH). This condition results in disturbances in vitamin D, phosphorus, calcium and PTH metabolism and bone disorders and has been associated with cardiovascular complications increased mortality. Elevation of PTH higher than 300-450 pg/ml is associated with an increased all-cause mortality.
Since the introduction of Cinacalcet in 2004 the drug has changed global prescription patterns dramatically which shifted from surgery to dominantly medical treatment. However, cinacalcet has never been systematically compared with with (sub) total parathyroidectomy (PTx) and it has side effects (evolve trial 2012) is expensive and postpones definite treatment leading to morbidity.
Therefore the multicentre Rhino trial was initiated comparing PTx versus Cinacalcet.
Doel van het onderzoek
Total parathyroidectomy (PTX) in patients with secondary hyperparathyroidism (HPT2) is a more effective treatment than the use of Calcimimetica.
Onderzoeksopzet
first interim-analysis after one year, follow up in study two years.
Onderzoeksproduct en/of interventie
Total parathyroidectomy with transplantation versus the use of Cinacalcet
Publiek
Wetenschappelijk
Belangrijkste voorwaarden om deel te mogen nemen (Inclusiecriteria)
- Age > 18 years
- Newly diagnosed sHPT, defined as PTH level >9x ULN
-Hemodialysis or peritoneal dialysis patients
-> 3 months of chronic dialysis
- Signed informed consent
Belangrijkste redenen om niet deel te kunnen nemen (Exclusiecriteria)
-Cinacalcet use within the past 3 months
-Former renal transplant
-Former parathyroidectomy
-Former dialysis
-Malignancy in history
Opzet
Deelname
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In overige registers
Register | ID |
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NTR-new | NL5266 |
NTR-old | NTR5382 |
Ander register | ZonMW : 55288 |