End Stage Renal Disease Clinical Trial
Official title:
Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Uncontrolled Secondary Hyperparathyroidism in Chronic Haemodialysis Patients
Secondary hyperparathyroidism (sHPT) is common in patients with chronic kidney disease
(CKD), including those who are undergoing long-term haemodialysis treatment. sHPT is
characterized by persistently elevated levels of parathyroid hormone (PTH) and major
disturbances in phosphorus and calcium metabolism. When glomerular filtration rate (GFR)
falls, the phosphorus clearance decreases significantly, leading to phosphorus retention.
The resulting hyperphosphatemia is thought to be one of the principal causes of secondary
hyperparathyroidism which is a very early complication of patients with CKD. Its diagnosis
and treatment is crucial in the management of such patients.The treatment of the sHPT of
CKD's patient includes dietary phosphate restriction, the use of phosphate binders,
correction of hypocalcaemia, the use of vitamin D and its derivatives. The calcimimetic
agent cinacalcet hydrochloride may be also used in combination with vitamin D. While the
majority of patients can be controlled in this way, medical therapy is not always successful
in achieving adequate control of secondary hyperparathyroidism. Oral medications
(calcimimetics, recently developed phosphate binders, and active vitamin D derivatives
amount to very high monthly costs, and have efficacy limitations as well as side-effects.
HIFU may become a valuable alternative treatment that help control secondary
hyperparathyroidism in selected patients presenting with enlarged parathyroid gland(s)
visible at ultrasonography,.
The aim of this study is to evaluate the efficacy and safety of HIFU treatment in chronic
haemodialysis patients with secondary hyperparathyroidism presenting with enlarged
parathyroid gland(s) which are visible at ultrasonography and for whom medical therapy has
been unsuccessful.
n/a
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment
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