Trial record 12 of 69 for:    Open Studies | "Parathyroid Diseases"

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

The recruitment status of this study is unknown because the information has not been verified recently.
Verified August 2011 by Theraclion.
Recruitment status was  Recruiting
Sponsor:
Information provided by (Responsible Party):
Theraclion
ClinicalTrials.gov Identifier:
NCT01421407
First received: August 19, 2011
Last updated: August 29, 2011
Last verified: August 2011
  Purpose

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.


Condition Intervention
Secondary Hyperparathyroidism
End Stage Renal Disease
Parathyroid Hyperplasia
Device: Ultrasonic ablation device

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Efficacy and Safety of High Intensity Focused Ultrasound (HIFU) Device to Treat Uncontrolled Secondary Hyperparathyroidism in Chronic Haemodialysis Patients

Resource links provided by NLM:


Further study details as provided by Theraclion:

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. [ Time Frame: 6 months after the last HIFU session ] [ Designated as safety issue: No ]

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) [ Time Frame: at 6 months after last HIFU session ] [ Designated as safety issue: No ]

Estimated Enrollment: 30
Study Start Date: August 2011
Estimated Study Completion Date: January 2014
Estimated Primary Completion Date: August 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Active Comparator: High Intensity Focused Ultrasound Device: Ultrasonic ablation device
High Intensity Focused Ultrasound treatment
Other Name: TH-One
No Intervention: Control group

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01421407

Contacts
Contact: Angel Luis Martin DE FRANCISCO, Pr +34 942 202 738 angelmartindefrancisco@gmail.com

Locations
Italy
Ospedale generale regionale "Miulli" Recruiting
Acquaviva delle Fonti, Italy, 70021
Contact: Carlo BASILE, Dr    0039 08 03 05 42 05    basile.miulli@libero.it   
Contact: Carlo LOMONTE, Dr    0039 08 03 05 42 05    carlolomonte@libero.it   
Principal Investigator: Carlo BASILE, DR         
Ospedale Maggiore Policlinico Mangiagalli e Regina Elena Not yet recruiting
Milano, Italy, 20122
Contact: Piergiorgio MESSA, Pr    0039 02 55 03 45 51    pmessa@policlinico.mi.it   
Principal Investigator: Piergiorgio MESSA, Pr         
Spain
Hospital Universitario Marquès de Valdecilla Recruiting
Santander, Cantabria, Spain, 39008
Contact: Angel Luis Martin DE FRANCISCO, Pr    +34 (942) 202738    angelmartindefrancisco@gmail.com   
Principal Investigator: Angel Luis Martin DE FRANCISCO, Pr         
Sponsors and Collaborators
Theraclion
Investigators
Principal Investigator: Angel Luis Martin DE FRANCISCO, Pr Hospital Universitario Valdecilla. Santander. Spain
  More Information

No publications provided

Responsible Party: Theraclion
ClinicalTrials.gov Identifier: NCT01421407     History of Changes
Other Study ID Numbers: HIFU/E/HPT2/Jan2011
Study First Received: August 19, 2011
Last Updated: August 29, 2011
Health Authority: Spain: Ethics Committee
Italy: Ethics Committee

Keywords provided by Theraclion:
Secondary hyperparathyroidism
End stage renal disease
Parathyroid hyperplasia
High Intensity Focused Ultrasound

Additional relevant MeSH terms:
Parathyroid Diseases
Hyperparathyroidism
Hyperparathyroidism, Secondary
Hyperplasia
Kidney Diseases
Kidney Failure, Chronic
Hyperparathyroidism, Primary
Endocrine System Diseases
Pathologic Processes
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency

ClinicalTrials.gov processed this record on April 17, 2014