An interventional study of microwave ablation and active vitamin D in Secondary Hyperparathyroidism and Maintenance Hemodialysis, sponsored by Wenhu Liu. Status unknown at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2016-05-24.
Sponsored by Wenhu Liu · Not applicable, Interventional, and Treatment
Among 23 studies in Hyperparathyroidism, Secondary with a site in China — 4 open to participants now, 5 under way, 1 of them phase 3. Hyperparathyroidism, Secondary · China.
Among the 23 studies in Hyperparathyroidism, Secondary with a site in China, this one is the 16th largest by planned enrollment of the 18 interventional ones, is one of 2 that started in 2015, is one of 2 with no phase, and was the 2nd registered.
188 studies on the registry are indexed under Hyperparathyroidism, Secondary; 15 are open to participants now.
This study's planned enrollment of 30 is below the median of 62 across 146 interventional studies indexed under Hyperparathyroidism, Secondary.
Browse Hyperparathyroidism, Secondary studies →4 of the 23 studies in Hyperparathyroidism, Secondary with a site in China are open now, in 1 country. Each count lists the studies.
Of the 10 Hyperparathyroidism, Secondary studies recruiting now, 5 (50%) set no upper age limit and 4 (40%) stop at 75 or younger; 4 take children under 18; 1 take healthy volunteers.
This study: 18 Years to 75 Years · all sexes · no healthy volunteers.
The full table on the hub →23 studies; the count open now beside each. This study's row is marked.
First in 2009; this study’s year is marked. 2 started in 2015.
Median enrollment 158 across the 18 interventional studies, 192 across the 5 observational. Of the 14 that completed or were terminated, 3 (21%) have results posted.
15 of 23 have an industry lead sponsor. The 10 most frequent:
Wenhu Liu is the lead sponsor of 4 studies on the registry; none are open to participants now.
Wenhu Liu has 1 study filed under Hyperparathyroidism, Secondary — fewer than ten, so there is no comparison to draw.
1 of the studies in Hyperparathyroidism, Secondary with a site in China that are under way reach primary completion within a year, 1 of them phase 3. Phase 3 first, then by date:
| Study | Primary completion |
|---|---|
| NCT07122401Phase 3Shaanxi Micot Pharmaceutical Technology Co., Ltd.Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism | 2026-11-26 |
Among the 23 studies in Hyperparathyroidism, Secondary with a site in China, from their registry updates:
Nothing recorded among them since 2026-09-25.
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.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
patients in ultrasonic ablation will be treated by ultrasound guided percutaneous parathyroid gland microwave ablation
Procedure: 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
Drug: active vitamin D
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.
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.
Overall rate of achieving target for iPTH during the study period.
The blood level of intact iPTH will be detected every other month for stable patients.
Time frame: 12 months
The change of iPTH level after MWA.
The blood level of intact iPTH will be detected every other month for stable
Time frame: 12 months
The rate of subjects developed into severe SHPT
Time frame: 12 months
Calcitriol weekly dosage.
calcification score in every 6 months
Time frame: 12 months
Overall rate of achieving target for serum calcium and phosphorus.
Time frame: 12 months
Changes of serum calcium and phosphorus after MWA.
The blood level of bone specific alkaline phosphatase will be detected every other months
Time frame: 12 months
The record gives a start of Jan 2015, a primary completion of Mar 2017 and a completion of Mar 2018. It does not say whether these dates are actual or estimated.
How these figures are worked out, and which studies are left out of them.
This study is status unknown, as verified in May 2016. You cannot join it, but the record below documents what was studied.
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Hyperparathyroidism, Secondary →
Wenhu Liu