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New treatment option for Hemodialysis Subjects With Secondary Hyperparathyroidism
Official title A Mass Balance Study of [14C] MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
ClinicalTrials.gov ID: NCT07284043
What this study is testing
What is [14C] MT1013/MT1013 Injection?
[14C] MT1013/MT1013 Injection is an investigational medicine, given as an injectable medicine, being studied as a potential treatment for hemodialysis subjects with secondary hyperparathyroidism.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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.
- Phase 1: an early, usually small safety study
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
- 2\. The BMI is between 18 kg/m2 and 35 kg/m2;
- 3\. The people must undergo regular maintenance hemodialysis three times a week for at least three months；
- 4\. Within 14 days prior to randomization, people must have serum calcium levels≥ 8.4 mg/dL;
- 5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
You likely can't join if
- 1\. The people underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during...
- 2\. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3\. The people had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
- 4．people with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg;
- 5\. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- 6\. History of malignant tumors within the five years prior to screening;
See the full eligibility criteria
- 1\. Male or postmenopausal female participants, aged 18 years or older, with a confirmed diagnosis of SHPT.
- 2\. The BMI is between 18 kg/m2 and 35 kg/m2;
- 3\. The people must undergo regular maintenance hemodialysis three times a week for at least three months；
- 4\. Within 14 days prior to randomization, people must have serum calcium levels≥ 8.4 mg/dL;
- 5.Subject capable of understanding written information ,willing to participate in, and provide a written informed consent;
- 1\. The people underwent parathyroidectomy within 6 months prior to screening, or plan to undergo parathyroidectomy or ablation or radiation during the study;
- 2\. Gastrointestinal bleeding or peptic ulcer medical history within 6 months prior to screening;
- 3\. The people had myocardial infarction or had undergone coronary angioplasty or coronary artery bypass grafting within 6 months before screening.
- 4．people with severe uncontrolled hypertension, defined as systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg;
- 5\. History of epileptic seizures or ongoing epilepsy related treatment within 1 year prior to screening;
- 6\. History of malignant tumors within the five years prior to screening;
- 7\. The people received oral cinacalcet or ivocalcet within 7 days before signing the informed consent form, or received Etelcalcetide injection treatment within 4 months.
- 8\. Engaged in work that requires long-term exposure to radioactive conditions; Or those who have had significant radioactive exposure or participated in radioactive drug labeling tests within one year prior to...
- 9\. Participants who may not be able to complete this study for other reasons or who the researchers consider should not be included.
The study team makes the final eligibility decision.
Where it's taking place
- Jinan, Shandong, China
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Jinan, Shandong, China. Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.