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Parathyroidectomy versus cinacalcet for the correction of secondary hyperparathyroidism in hemodialysis patients


- candidate number22795
- NTR NumberNTR5382
- ISRCTNISRCTN no longer applicable
- Date ISRCTN created
- date ISRCTN requested
- Date Registered NTR25-aug-2015
- Secondary IDs55288 ZonMW
- Public TitleParathyroidectomy versus cinacalcet for the correction of secondary hyperparathyroidism in hemodialysis patients
- Scientific TitleParathyroidectomy versus cinacalcet for the correction of secondary hyperparathyroidism in hemodialysis patients
- ACRONYMRHINO trial
- hypothesisTotal parathyroidectomy (PTX) in patients with secondary hyperparathyroidism (HPT2) is a more effective treatment than the use of Calcimimetica.
- Healt Condition(s) or Problem(s) studiedChronic renal failure, Total parathyroidectomy
- Inclusion criteria- 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
- Exclusion criteria-Cinacalcet use within the past 3 months
-Former renal transplant
-Former parathyroidectomy
-Former dialysis
-Malignancy in history
- mec approval receivedno
- multicenter trialyes
- randomisedyes
- masking/blindingNone
- controlNot applicable
- groupCrossover
- Type2 or more arms, randomized
- Studytypeintervention
- planned startdate 1-jan-2016
- planned closingdate1-jan-2020
- Target number of participants128
- InterventionsTotal parathyroidectomy with transplantation versus the use of Cinacalcet
- Primary outcomePTH 3 months after the intervention
- Secondary outcome- cardiovascular events (myocardial infarction, peripheral vascular disease, instable angina, cerebrovascular disease, CVA, TIA), arrhythmias)
- Costs
- phosphorus, calcium
- fibroblast growth factor 23 levels
- renal function
- all-cause mortality
- Timepointsfirst interim-analysis after one year, follow up in study two years.
- Trial web sitenot ready; will follow
- statusplanned
- CONTACT FOR PUBLIC QUERIES Schelto Kruijff
- CONTACT for SCIENTIFIC QUERIES Schelto Kruijff
- Sponsor/Initiator Kruijff
- Funding
(Source(s) of Monetary or Material Support)
- Publications
- Brief summarySecondary 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.
- Main changes (audit trail)
- RECORD25-aug-2015 - 13-okt-2015


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