Trial Outcomes & Findings for Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients (NCT NCT01640184)

Last Updated: 2016-10-17

Results Overview

The blood levels of intact parathyroid hormone (iPTH) will be detected every 3 months for stable patients. The blood test will be more frequent, at least once per-month, after the ultrasonic ablation treatment, surgery, or during the impulse therapy of active vitamin D with large doses.

Recruitment status

COMPLETED

Study phase

Target enrollment

79 participants

Primary outcome timeframe

12 months

Results posted on

2016-10-17

Participant Flow

Participant milestones

Participant milestones
Measure	Active Vitamin D Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Overall Study STARTED	34	23	22
Overall Study COMPLETED	26	21	20
Overall Study NOT COMPLETED	8	2	2

Reasons for withdrawal

Reasons for withdrawal
Measure	Active Vitamin D Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Overall Study Death	1	0	0
Overall Study Lost to Follow-up	4	1	0
Overall Study Physician Decision	3	0	0
Overall Study Withdrawal by Subject	0	1	1
Overall Study Protocol Violation	0	0	1

Baseline Characteristics

Efficacy and Safety of Ultrasonic Ablation to Treat Secondary Hyperparathyroidism in Chronic Kidney Disease Patients

Baseline characteristics by cohort

Baseline characteristics by cohort
Measure	Active Vitamin D n=34 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=23 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=22 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.	Total n=79 Participants Total of all reporting groups
Age, Continuous	56.3 years n=5 Participants	52.0 years n=7 Participants	55.2 years n=5 Participants	55.3 years n=4 Participants
Sex: Female, Male Female	20 Participants n=5 Participants	12 Participants n=7 Participants	13 Participants n=5 Participants	45 Participants n=4 Participants
Sex: Female, Male Male	14 Participants n=5 Participants	11 Participants n=7 Participants	9 Participants n=5 Participants	34 Participants n=4 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Asian	34 Participants n=5 Participants	23 Participants n=7 Participants	22 Participants n=5 Participants	79 Participants n=4 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Black or African American	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) White	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) More than one race	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Race (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants	0 Participants n=7 Participants	0 Participants n=5 Participants	0 Participants n=4 Participants
Region of Enrollment China	34 participants n=5 Participants	23 participants n=7 Participants	22 participants n=5 Participants	79 participants n=4 Participants
Ca-baseline	2.31 mmol/L STANDARD_DEVIATION 0.27 • n=5 Participants	2.43 mmol/L STANDARD_DEVIATION 0.30 • n=7 Participants	2.53 mmol/L STANDARD_DEVIATION 0.23 • n=5 Participants	2.41 mmol/L STANDARD_DEVIATION 0.30 • n=4 Participants
P-baseline	1.95 mmol/L STANDARD_DEVIATION 0.49 • n=5 Participants	2.14 mmol/L STANDARD_DEVIATION 0.66 • n=7 Participants	2.12 mmol/L STANDARD_DEVIATION 0.45 • n=5 Participants	2.10 mmol/L STANDARD_DEVIATION 0.51 • n=4 Participants
iPTH-baseline	239.84 ng/ml STANDARD_DEVIATION 299.01 • n=5 Participants	1550.6 ng/ml STANDARD_DEVIATION 521.7 • n=7 Participants	1779.9 ng/ml STANDARD_DEVIATION 514.1 • n=5 Participants	1201.8 ng/ml STANDARD_DEVIATION 498.7 • n=4 Participants
BALP-baseline	17.31 microgram/L STANDARD_DEVIATION 6.38 • n=5 Participants	18.84 microgram/L STANDARD_DEVIATION 17.94 • n=7 Participants	19.27 microgram/L STANDARD_DEVIATION 14.87 • n=5 Participants	17.98 microgram/L STANDARD_DEVIATION 13.32 • n=4 Participants

PRIMARY outcome

Timeframe: 12 months

Population: Number of participants analyzed is the number of patients completed study.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=26 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=21 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=20 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Rate of Achieving the Target on Blood Intact Parathyroid Hormone Level According to Kidney Development Improvement Global Outcome (KDIGO) Guidelines.	30.8 percentage of participants	57.1 percentage of participants	90.0 percentage of participants

SECONDARY outcome

Timeframe: 12 months

Comparison of the incidence of RLN injury between ultrasonic ablation group and parathyroidectomy group.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=21 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=20 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Incidence of Injury on the Recurrent Laryngeal Nerve (RLN).	0 participants	2 participants	—

SECONDARY outcome

Timeframe: Baseline and 12 months

The blood levels of calcium will be detected at least once every 3 months and will be compared to the baseline levels.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=26 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=21 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=20 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Changes of the Blood Levels on Calcium During 12 Months.	2.34 mmol/L Standard Deviation 0.22	1.84 mmol/L Standard Deviation 0.21	1.93 mmol/L Standard Deviation 0.26

SECONDARY outcome

Timeframe: Baseline and 12 months

The blood levels of phosphorus will be detected at least once every 3 months and will be compared to the baseline levels.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=26 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=21 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=20 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Changes of Blood Levels on Phosphorus During 12 Months.	1.91 mmol/L Standard Deviation 0.41	1.51 mmol/L Standard Deviation 0.29	1.29 mmol/L Standard Deviation 0.33

SECONDARY outcome

Timeframe: Baseline and 12 months

The blood levels of iPTH will be detected at least once every 3 months and will be compared to the baseline levels.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=26 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=21 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=20 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Changes of Blood Levels on iPTH During 12 Months.	252.2 ng/ml Standard Deviation 172.0	372.1 ng/ml Standard Deviation 253.6	246.5 ng/ml Standard Deviation 228.4

SECONDARY outcome

Timeframe: Baseline and 12 months

The blood levels of bone specific alkaline phosphatase will be detected at least once every 3 months and will be compared to the baseline levels.

Outcome measures

Outcome measures
Measure	Active Vitamin D n=26 Participants Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: chronic kidney disease (CKD) patients suffered from secondary hyperparathyroidism (sHPT) with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=21 Participants Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=20 Participants Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Changes of Blood Levels on Bone Specific Alkaline Phosphatase.	13.60 microgram/L Standard Deviation 5.86	19.48 microgram/L Standard Deviation 17.33	19.20 microgram/L Standard Deviation 17.95

Adverse Events

Active Vitamin D

Serious events: 1 serious events

Other events: 0 other events

Deaths: 0 deaths

Ultrasonic Ablation

Serious events: 0 serious events

Other events: 5 other events

Deaths: 0 deaths

Parathyroidectomy

Serious events: 0 serious events

Other events: 15 other events

Deaths: 0 deaths

Serious adverse events

Serious adverse events
Measure	Active Vitamin D n=34 participants at risk Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=23 participants at risk Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=22 participants at risk Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Cardiac disorders Death	2.9% 1/34 • Number of events 1	0.00% 0/23	0.00% 0/22

Other adverse events

Other adverse events
Measure	Active Vitamin D n=34 participants at risk Patients in oral medicine group will be treated by active vitamin D and other general treatments according to the suggestions in KDIGO guidelines. Active vitamin D: CKD patients suffered from sHPT with 1-3 enlarged gland(s) and without indication of parathyroidectomy will be randomized to oral medicine therapy group or ultrasonic ablation therapy group. Patients in oral medicine group will be treated by active vitamin D and other general treatments, such as dietary phosphate restriction and phosphate binders, according to the suggestions in KDIGO guidelines.	Ultrasonic Ablation n=23 participants at risk Patients in Ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequency ablation. Ultrasonic ablation: CKD-sHPT patients with enlarged parathyroid gland(s) randomized into the ultrasonic ablation group will be treated by ultrasound guided percutaneous parathyroid gland radio frequence ablation. According to the indications of parathyroid surgery, the patients will be divided into two sub-groups. The outcomes of these patients will be compared to the oral medicine group and the parathyroidectomy group, respectively.	Parathyroidectomy n=22 participants at risk Patients in parathyroidectomy group will be treated by parathyroid surgery. Parathyroidectomy: sHPT patients with enlarged glands (≥3)will be randomized into parathyroidectomy group or ultrasonic ablation group. Patients in parathyroidectomy will get parathyroid surgery.
Injury, poisoning and procedural complications Hypocalcemia	0.00% 0/34	8.7% 2/23 • Number of events 2	68.2% 15/22 • Number of events 15
Injury, poisoning and procedural complications Hoarse	0.00% 0/34	21.7% 5/23 • Number of events 5	36.4% 8/22 • Number of events 8

Additional Information

Dr. Zhang Dongliang

Peking University International Hospital

Phone: +86-10-69006561

Email: [email protected]

Results disclosure agreements

Principal investigator is a sponsor employee
Publication restrictions are in place