A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subj… (NCT06747247) | Clinical Trial Compass
CompletedPhase 2
A Clinical Study Evaluating the Safety, Tolerability, and Efficacy of MT1013 in Hemodialysis Subjects With Secondary Hyperparathyroidism
China98 participantsStarted 2023-04-07
Plain-language summary
A multicenter, Phase II, randomized, double-blind, single ascending dose (SAD) and multiple ascending dose (MAD), as well as single-arm clinical study evaluating the long-term efficacy and safety of MT1013 in hemodialysis subjects with secondary hyperparathyroidism. The SAD study consists of five cohorts at doses of 5, 10, 20, 40, and 60 mg. The MAD study consists of three cohorts at doses of 5, 10, and 20 mg. In both the SAD and MAD studies, each cohort includes 8 subjects (6 subjects receive the active investigational drug, and 2 subjects receive matching placebo), and the cohorts are conducted sequentially. In the long-term dosing cohort, all subjects will undergo regular hemodialysis three times per week, receiving the drug once after each hemodialysis session for a total duration of 52 weeks
Who can participate
Age range
18 Years – 80 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Male or non- pregnant, non-lactating female aged 18 to 80;
. The patient has been on stable, adequate hemodialysis treatment for \>3 months prior to screening;
. Intact parathyroid hormone (iPTH) level of at least 300 pg/mL;
. Serum calcium (corrected serum calcium if albumin \<40 g/L) ≥2.25 mmol/L (9.0mg/dL);
. Hemoglobin ≥ 8.0 g/dL;
. Subject is clinically stable, as judged by medical history, physical examination, and routine laboratory tests, apart from chronic renal failure;
. Able to understand and willing to sign the written informed consent form;
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
SAD/MAD :Percentage of treatment-emergent adverse events (TEAEs)
Timeframe: SAD：on Day 8±1. MAD：on Day 16+2 or 30+2 and Day 21±2 or 35±2
2
Long-term Dosing Cohort: Proportion of subjects with > 30% reduction in serum iPTH compared to baseline level.
. Women of childbearing potential must have a negative pregnancy test result prior to enrollment, or be postmenopausal for at least 1 year, or be permanently sterile(i.e., documented hysterectomy, bilateral salpingectomy, or bilateral oophorectomy) for ≥6 weeks. Fertile men with partners of childbearing potential and women of childbearing potential must use effective contraception (i.e., any combination of two of the following: male or female condom with spermicidal gel,diaphragm, sponge, or cervical cap with spermicidal gel) from signing the informed consent until 90 days after MT1013 infusion.
Exclusion criteria
.History of organ transplant (excluding being on the kidney transplant waiting list), hematopoietic stem cell transplant, or bone marrow transplant; or patients planning to undergo organ transplantation;
.Severe uncontrolled hypertension, defined as systolic blood pressure \>180 mmHg and diastolic blood pressure \>100 mmHg despite optimal medical therapy before enrollment;
.Known malignancy or other comorbidities with a life expectancy of \<3 months (except for patients disease-free for ≥5 years, or disease-free for ≥5 years after the last dose of chemotherapy );
0.Known alcohol or illicit drug abuse within 12 months prior to screening, unwillingness or inability to abstain from alcohol for 24 hours prior to each study visit, or unwillingness or inability to limit alcohol consumption to a maximum of 2 drinks per day during the study (one drink is equivalent to 360 mL of regular beer, 150 mL of wine, or 45 mL of 40% alcohol spirits);
1.Positive for human immunodeficiency virus (HIV) or known diagnosis of acquired immunodeficiency syndrome (AIDS) at screening;
2.Subjects positive for hepatitis B surface antigen (HBsAg) at screening (indicative of chronic hepatitis B) AND with serum transaminases (alanine aminotransferase, aspartate aminotransferase) \>2 times the upper limit of normal;
3.Positive for hepatitis C virus ribonucleic acid (RNA) by polymerase chain reaction (PCR) at screening (indicative of active hepatitis C - usually screened via hepatitis C antibody \[HCV-Ab\], with PCR for HCV RNA if HCV-Ab positive);
4.Patients with known hypersensitivity to the investigational product and/or its components;