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Hyperparathyroidism, Secondary

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Vitamins

Vitamin D

Cholecalciferol

Calcitriol

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Calcium

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Vitamin D3

Calciferol

titrated to achieve 40-60% PTH suppression

1 mcg daily, adjusted to achieve 40-60% PTH suppression

Paricalcitol

0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Daniel W Coyne, MD

Secondary Hyperparathyroidism (SHPT) occurs in many patients with kidney disease and leads to bone disease. Active forms of vitamin D, calcitriol and paricalcitol, treat SHPT, but may have different effects on blood calcium. This study will randomize patients with SHPT and stage 3 or 4 CKD to treatment with calcitriol or paricalcitol, and monitor patients for the incidence of high blood calcium, and effectiveness of SHPT treatment.

General Design

* Open label, active comparator, multicenter, parallel group, phase 4 study of paricalcitol versus calcitriol for suppression of PTH in stage 3 and 4 CKD patients with SHPT.
* Total study duration is 26 weeks (1 week screening, 24 weeks active medications, 1 week follow up.
* Patients meeting inclusion/exclusion criteria including baseline laboratory results will be randomized to paricalcitol or calcitriol, and enter a 24 weeks treatment phase. Visits, including safety and efficacy laboratory tests will be at weeks 4, 8, 12, 18, and 24. A follow up visit will be performed 1 week after stopping study medication.

Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)

A Phase 4 Randomized Multicenter Open Label Trial of Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3 or 4 Ckd Patients With Secondary Hyperparathyroidism

Serum Calcium 10.5 mg/dL or higher, confirmed by repeat measurement.

Henry Ford Hospital

Northwestern University Feinberg School of Medicine

NorthShore University HealthSystem

Abbott

Washington University School of Medicine

Professor of Medicine

titrated to achieve 40-60% PTH suppression

Paricalcitol: 1 mcg daily, adjusted to achieve 40-60% PTH suppression

titrated to achieve 40-60% PTH suppression

Calcitriol: 0.25 mcg daily, adjusted to achieve 40-60% PTH suppression

Total

Age, Continuous

Sex: Female, Male

Race (NIH/OMB)

Stage 3 and 4 CKD with SHPT, age \>18, a stable dose of phosphate binder (if receiving a binder), estimated glomerular filtration rate (eGFR) of 15-59 mL/min using the abbreviated MDRD equation, PTH \>120 pg/mL, albumin-corrected calcium \>8.5 mg/dL and \<10.0 mg/dL, phosphorus \<4.6 mg/dL.

Dr. Daniel W. Coyne

Confirmed Hypercalcemia

Overall Study

Parathyroid Hormone

patients in ultrasonic ablation will be treated by ultrasound guided percutaneous parathyroid gland microwave ablation

patients in control group will be treated by active vitamin D and other general treatments according to the suggestions in K/DOQI guidelines

First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. Patients are divided into 2 groups at random, the control group and the microwave ablation group. In the microwave ablation group, patients will accept microwave ablation. Oral medicines, if needed, will be taken according to the the suggestions in K/DOQI guideline.

microwave ablation

The control group will be treated by active vitamin D and other general treatment,such as dietary phosphate restriction and phosphate binders,according to the suggestions in K/DOQI guideline.

active vitamin D

Zongli Diao, master

Wenhu Liu, Doctor

Zongli Diao, Master

Wenhu Liu, doctor

Linxue Qian, doctor

Microwave ablation, as a new method to therapy secondary hyperparathyroidism(SHPT), now is developing rapidly. However, it is still unknown whether it is effective to accept microwave ablation for hemodialysis patients with mild-to-moderate SHPT. In this prospective, randomised control and paried clinical trial study, the investigators will observe the efficiency and safety of microwave ablation in hemodialysis patients with mild-to-moderate secondary hyperparathyroidism. The patients in age-matched control group will accept active Vitamin D therapy.

Secondary hyperparathyroidism(SHPT) is common in hemodialysis(HD) patients. SHPT can damage cardiovascular system , bone system, and so forth. The treatment of SHPT of HD patients includes dietary phosphate restriction, the use of medicines, parathyroidectomy, and microwave ablation, which is a new method booming over the past decade. However, In the mainland of China, medical therapy is not always successful in achieving adequate control of SHPT. Oral medications have limitations as well as side effects. The patients may suffer from the injury of operation, hypoparathyroidism, or recurrence of hyperparathyroidism after parathyroidectomy. Moreover, the fear of operation for patients also limits its development. Thus, microwave ablation may become a valuable alternative treatment to help control SHPT in selected patients presenting with enlarged parathyroid gland(s) visible at ultrasonography. Nevertheless, nowadays there isn't a guideline for doctors to choose when to use microwave ablation to therapy SHPT. Furthermore, different experts have different views. Experts in Japan consider that, for SHPT , the earlier one takes microwave ablation, the better he may be, while others think, Just as parathyroidectomy, microwave ablation is merely used for the patient whose intact parathyroid hormone (iPTH) is more than 800pg/ml, or who has serious symptom. From their perspective, this is no proof that accepting microwave ablation for SHPT in early stage becomes better. However, as we all know, as the disease progresses, the therapy becomes increasingly difficult. Since microwave ablation is minimally invasive, safe,the investigators consider, patients who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan would get more benefit if they undergo microwave ablation the instant that SHPT is diagnosed. So, In this prospective, randomised control and paried clinical trial study, the investigators will observe the efficiency and safety of microwave ablation in hemodialysis patients with secondary hyperparathyroidism in early stage. First, the investigators detect the iPTH levels of all the patients in the investigators' blood purification center. The patients whose iPTH are between 300pg/ml and 800pg/ml and who have parathyroid nodular or diffuse hyperplasia demonstrated on ultrasound imaging or radioisotope scan are chosen to involve in this study. The patients with age-matched and iPTH between 300pg/ml and 800pg/ml were enrolled in this study. In the control group, patients will accept vitamin D to treat SHPT, according to the suggestions in K/DOQI guidelines. Meanwhile, in the microwave ablation group, patients will accept microwave ablation. Then, all of the patients will be followed for 24 months to compare the rate of achieving the target on iPTH level according to K/DOQI guidelines, the change of iPTH level after MWA,the rate of subjects developed into severe SHPT, as well as calcium and phosphorus level, Quality of Life and mortality in each group.

The Efficacy and Safety of Microwave Ablation for Mild-to-moderate Secondary Hyperparathyroidism Patients Undergoing Hemodialysis

The blood level of intact iPTH will be detected every other month for stable patients.

The blood level of intact iPTH will be detected every other month for stable

The blood level of bone specific alkaline phosphatase will be detected every other months

Study title	NCT ID	Conditions	Interventions	Eligibility	Organization
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)	NCT00823303	Secondary Hyper... Chronic Kidney ...	Paricalcitol Calcitriol	18 Years -	Washington University School of Medicine
The Efficacy and Safety of Microwave Ablation for Mild-to-moderate Secondary Hyperparathyroidism Patients Undergoing Hemodialysis	NCT02332135	Secondary Hyper... Maintenance Hem...	microwave ablat... active vitamin ...	18 Years - 75 Years	Beijing Friendship Hospital
Paricalcitol Versus Calcitriol for Efficacy and Safety in Stage 3/4 Chronic Kidney Disease (CKD) With Secondary Hyperparathyroidism (SHPT)	NCT00823303	Secondary Hyper... Chronic Kidney ...	Paricalcitol Calcitriol	18 Years -	Washington University School of Medicine

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