Actively Recruiting
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Led by Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Updated on 2025-12-16
6
Participants Needed
1
Research Sites
65 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
MT1013 is a first-in-class dual-target agonist.This study is being conducted to determine the mass balance and routes of excretion of total radioactivity after the dose of \[14C\] MT1013.
CONDITIONS
Official Title
A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Male or postmenopausal female participants aged 18 years or older with confirmed secondary hyperparathyroidism
- Body mass index (BMI) between 18 kg/m2 and 35 kg/m2
- Undergoing regular maintenance hemodialysis three times a week for at least three months
- Serum calcium levels of 8.4 mg/dL or higher within 14 days prior to randomization
- Able to understand written information and willing to provide written informed consent
You will not qualify if you...
- Parathyroidectomy within 6 months prior to screening, or planned parathyroidectomy, ablation, or radiation during the study
- History of gastrointestinal bleeding or peptic ulcer within 6 months prior to screening
- Myocardial infarction or coronary artery procedures within 6 months before screening
- Severe uncontrolled hypertension with systolic blood pressure over 180 mmHg or diastolic blood pressure over 110 mmHg
- History of epileptic seizures or epilepsy treatment within 1 year prior to screening
- History of malignant tumors within 5 years prior to screening
- Use of oral cinacalcet or ivocalcet within 7 days before consent or Etelcalcetide injection within 4 months
- Long-term exposure to radioactive conditions or significant radioactive exposure within 1 year prior to screening
- Any other reason preventing completion of the study as judged by researchers
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 1 location
1
The First Affiliated Hospital of Shandong First Medical University (Shandong Qianfoshan Hospital)
Jinan, Shandong, China, 250014
Actively Recruiting
Research Team
W
Wei Zhao, Ph.D.
CONTACT
Y
Yong Wei, Ph.D.
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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