overactive parathyroids due to chronic renal failure parathyroid hyperplasie
Conditions
Interventions
(sub-)total parathyroidectomy versus cinacalcet
cinacalcet
Parathyroidectomy
secondary hyperparathyroidism
Sponsors
Universitair Medisch Centrum Groningen
Eligibility
Age
18 Years to 64 Years
Inclusion criteria
Inclusion criteria: - Diagnosed end-stage renal disease - PTH * 9 ULN - Calcium * 2.2 mmol/L - Female or male aged at least 18 years - *3 months of chronic dialysis - The patient must speak the Dutch language - The patient understands the purpose and risk of the study and has given written informed consent to participate in the study - On cinacalcet therapy with PTH * 9 ULN when commencing therapy - Patients have been treated with standard medical care, comprising of vitamin D and/or phosphate binders
Exclusion criteria
Exclusion criteria: * Calcium levels
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Of this pilot study: inclusion rate Of the RHINO trial: Quality of Life, measured by the KDQOL-36 questionnaire | — |
Secondary
| Measure | Time frame |
|---|---|
| - VAS scores of 13 HPT related symptoms - PTH levels - Costs - cardiovascular events - QALY (measured by the EQ-5D vragenlijst) - Adverse events (cinacalcet group) c.q. complications (PTx group) - renal function (eGFR) - Biochemical parameters for mineral metabolism (calcium, phosphate, albumin, alkaline phosphatase, FGF-23) - All-cause mortality | — |
Countries
The Netherlands
Outcome results
None listed