End Stage Renal Disease, Parathyroid Hyperplasia, Secondary Hyperparathyroidism
Conditions
Keywords
Secondary hyperparathyroidism, End stage renal disease, Parathyroid hyperplasia, High Intensity Focused Ultrasound
Brief summary
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.
Interventions
High Intensity Focused Ultrasound treatment
Sponsors
Theraclion
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
* Male or female patients 18 years or older with end stage renal disease (ESRD) on thrice-weekly stable haemodialysis since at least 3 months with biochemically uncontrolled secondary hyperparathyroidism. * PTH \> 800 pg/ml with serum calcium \> 8.4 mg/dl shown by three measurements obtained within a 30-day screening period, in spite of established maintenance dose for at least 3 months of Cinacalcet (\>30mg/day) with or without vitamin D . * Patients who underwent subtotal parathyroidectomy or total parathyroidectomy without autotransplantation and have recurrent secondary hyperparathyroidism, are eligible provided that they meet all the other inclusion criteria and
Exclusion criteria
. * Patients with one or two enlarged parathyroid glands, located with ultrasonography and with one or two over-active glands at sestamibi scintigraphy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of patients with a reduction from baseline of at least 30% in mean serum iPTH levels at 6 months after the last HIFU session and continuation of optimal medical therapy. | 6 months after the last HIFU session |
Secondary
| Measure | Time frame |
|---|---|
| Proportion of patients with a serum PTH in the KDIGO in the recommended range (approximately two to nine times the upper normal limit for the assay) | at 6 months after last HIFU session |
Countries
Italy, Spain
Outcome results
None listed