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Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

Primary Purpose

Secondary Hyperparathyroidism, End Stage Renal Disease, Parathyroid Hyperplasia

Status

Withdrawn

Phase

Not Applicable

Locations

International

Study Type

Interventional

Intervention

Ultrasonic ablation device

About this trial

This is an interventional treatment trial for Secondary Hyperparathyroidism focused on measuring Secondary hyperparathyroidism, End stage renal disease, Parathyroid hyperplasia, High Intensity Focused Ultrasound

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Exclusion Criteria:

Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
Serum total calcium (corrected for albumin) < 8.4 mg/dl (2.1 mmol/l)
Serum ionized calcium < 1 mmo/l.
Patient who underwent total parathyroidectomy with autotransplantation.
Known history of parathyroid or other neoplasias in the neck region.
History of neck irradiation
Patients with abnormal vocal cord mobility revealed by indirect laryngoscopy
Patients with enlarged parathyroid glands, not accessible to HIFU treatment.
Head and/or neck disease that prevents hyperextension of neck. - Major surgery or arterio-venous fistula clotting in the last 3 months or major surgery projected in the subsequent 4 months.
Pregnant or lactating woman.
Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Patient receiving drugs such as flecainide, thioridazine, and most tricyclic antidepressants.
Patients who are currently participating in another clinical trial.

Sites / Locations

Ospedale generale regionale "Miulli"
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena
Hospital Universitario Marquès de Valdecilla

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

No Intervention

Arm Label

High Intensity Focused Ultrasound

Control group

Arm Description

Outcomes

Primary Outcome Measures

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.

Secondary Outcome Measures

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)

Full Information

NCT ID

NCT01421407

First Posted

August 19, 2011

Last Updated

May 5, 2014

Sponsor

Theraclion

1. Study Identification

Unique Protocol Identification Number

NCT01421407

Brief Title

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

Official Title

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Uncontrolled Secondary Hyperparathyroidism in Chronic Haemodialysis Patients

Study Type

Interventional

2. Study Status

Record Verification Date

May 2014

Overall Recruitment Status

Withdrawn

Study Start Date

August 2011 (undefined)

Primary Completion Date

January 2014 (Actual)

Study Completion Date

January 2014 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Theraclion

4. Oversight

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

Secondary Hyperparathyroidism, End Stage Renal Disease, Parathyroid Hyperplasia

Keywords

Secondary hyperparathyroidism, End stage renal disease, Parathyroid hyperplasia, High Intensity Focused Ultrasound

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

High Intensity Focused Ultrasound

Arm Type

Active Comparator

Arm Title

Control group

Arm Type

No Intervention

Intervention Type

Device

Intervention Name(s)

Ultrasonic ablation device

Other Intervention Name(s)

TH-One

Intervention Description

High Intensity Focused Ultrasound treatment

Primary Outcome Measure Information:

Title

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.

Time Frame

6 months after the last HIFU session

Secondary Outcome Measure Information:

Title

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)

Time Frame

at 6 months after last HIFU session

10. Eligibility

Sex

All

Minimum Age & Unit of Time

18 Years

Accepts Healthy Volunteers

Eligibility Criteria

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. Exclusion Criteria: Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation). Serum total calcium (corrected for albumin) < 8.4 mg/dl (2.1 mmol/l) Serum ionized calcium < 1 mmo/l. Patient who underwent total parathyroidectomy with autotransplantation. Known history of parathyroid or other neoplasias in the neck region. History of neck irradiation Patients with abnormal vocal cord mobility revealed by indirect laryngoscopy Patients with enlarged parathyroid glands, not accessible to HIFU treatment. Head and/or neck disease that prevents hyperextension of neck. - Major surgery or arterio-venous fistula clotting in the last 3 months or major surgery projected in the subsequent 4 months. Pregnant or lactating woman. Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit. Patient receiving drugs such as flecainide, thioridazine, and most tricyclic antidepressants. Patients who are currently participating in another clinical trial.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

Angel Luis Martin DE FRANCISCO, Pr

Organizational Affiliation

Hospital Universitario Valdecilla. Santander. Spain

Official's Role

Principal Investigator

Facility Information:

Facility Name

Ospedale generale regionale "Miulli"

City

Acquaviva delle Fonti

ZIP/Postal Code

70021

Country

Italy

Facility Name

Ospedale Maggiore Policlinico Mangiagalli e Regina Elena

City

Milano

ZIP/Postal Code

20122

Country

Italy

Facility Name

Hospital Universitario Marquès de Valdecilla

City

Santander

State/Province

Cantabria

ZIP/Postal Code

39008

Country

Spain

12. IPD Sharing Statement

Learn more about this trial

Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Secondary Hyperparathyroidism

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