N/A
Completed N=79
Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients
Hyperparathyroidism · Disorders of Parathyroid Gland
Source: ClinicalTrials.gov NCT01640184 ↗
Enrolled (actual)
79
Serious AEs
1.3%
Results posted
Nov 2015
Primary outcomePrimary: Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. — 30.8; 57.1; 90.0 percentage of participants
Summary
It is difficulty for the treatment of secondary hyperparathyroidism in the chronic kidney disease (CKD) patients who had not succeeded medical therapy and could not get parathyroidectomy. The investigators suppose that ultrasonic ablation may be a valuable alternative treatment that help control secondary hyperparathyroidism in CKD patients presenting with enlarged parathyroid gland(s) visible at ultrasonography.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines. |
30.8; 57.1; 90.0 | — |
| SECONDARY Incidence of Injury on the Recurrent Laryngeal Nerve (RLN). |
0; 2 | — |
| SECONDARY Changes of the Blood Levels on Calcium During 12 Months. |
2.34; 1.84; 1.93 | — |
| SECONDARY Changes of Blood Levels on Phosphorus During 12 Months. |
1.91; 1.51; 1.29 | — |
| SECONDARY Changes of Blood Levels on iPTH During 12 Months. |
252.2; 372.1; 246.5 | — |
| SECONDARY Changes of Blood Levels on Bone Specific Alkaline Phosphatase. |
13.60; 19.48; 19.20 | — |
Eligibility Criteria
Inclusion Criteria
- Patients with age between 18 - 75 years.
- Patients with parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan.
- CKD patients in stage 5, with elevated intact parathyroid hormone (iPTH) levels > 800pg/mL.
- CKD patients have been followed up more than 6 months.
Exclusion Criteria
- Primary or Tertiary Hyperparathyroidism (hyperparathyroidism after kidney transplantation).
- Patient who underwent total parathyroidectomy and without enlarged parathyroid gland(s).
- Known history of parathyroid or other neoplasias in the neck region.
- History of neck irradiation.
- Major surgery of neck in the last 3 months or other major surgery projected in the subsequent 4 months.
- Pregnant or lactating woman.
- Patient receiving drugs such as phenobarbital, phenytoin, rifampicin, sucralfate, steroids, flecainide, thioridazine, or most tricyclic antidepressants which could affect vitamin D metabolism.
- Treatment with vitamin D derivatives, cinacalcet or other calcimimetics within the past 6 months.
- Patients who are currently participating in another clinical trial.
- The expected live time is less than 1 year.
- Patients suffered from acute myocardial infraction, acute congestive heart failure, or stroke in last 6 months.
- Patients whose concurrent illnesses, disability, or geographical residence would hamper attendance at required study visit.
Data sourced from ClinicalTrials.gov (NCT01640184). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.