No registrations found.
ID
Source
Brief title
Health condition
The use of Cinacalcet in secondary hyperparathyroidism and chronic renal failure
instead of Total parathyroidectomy
Sponsors and support
Hanzeplein 1a , Surgical department
s.kruijff@umcg.nl
Intervention
Outcome measures
Primary outcome
PTH 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
Background summary
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.
Study objective
Total parathyroidectomy (PTX) in patients with secondary hyperparathyroidism (HPT2) is a more effective treatment than the use of Calcimimetica.
Study design
first interim-analysis after one year, follow up in study two years.
Intervention
Total parathyroidectomy with transplantation versus the use of Cinacalcet
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
Design
Recruitment
Followed up by the following (possibly more current) registration
No registrations found.
Other (possibly less up-to-date) registrations in this register
No registrations found.
In other registers
| Register | ID |
|---|---|
| NTR-new | NL5266 |
| NTR-old | NTR5382 |
| Other | ZonMW : 55288 |