MT1013 injection for treating secondary hyperparathyroidism in dialysis patients
Official title: A Double-blind, Randomized, Placebo-controlled Clinical Trials With Single-ascending Dose(SAD) and Multiple-ascending Dose(MAD) Arms, as Well as a Single-arm to Assess the Safety, Tolerability, and Efficacy of MT1013 Injection in Patients With Secondary Hyperparathyroidism (SHPT) Undergoing Maintenance Dialysis
Run by Shaanxi Micot Technology Limited Company · NCT06747247 · Data updated 2026-05-14
This study is no longer in our active list. It may have stopped recruiting or finished. The details below are as of 2026-05-14 and are kept for reference. Check ClinicalTrials.gov for its current status, or see similar studies below.
This study is testing if an injection called MT1013 can help people with secondary hyperparathyroidism who are on dialysis feel better and stay healthier over time.
Quick facts
| Phase | Phase 2 |
|---|---|
| Study type | Interventional |
| Ages | 18 Years to 80 Years |
| Sex | All |
| Enrollment | 102 (estimated) |
| Sponsor | Shaanxi Micot Technology Limited Company Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06747247 on ClinicalTrials.gov |
Is this trial a fit for you?
✓Likely a good fit
Ideal candidates are patients receiving hemodialysis for at least three months with diagnosed secondary hyperparathyroidism and stable treatment regimens.
✕Probably not a fit
Patients who are not on hemodialysis or those with unstable medical conditions may not benefit from this study.
A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.
What this trial studies
This phase II clinical trial investigates the efficacy and safety of MT1013 in patients with secondary hyperparathyroidism (SHPT) undergoing maintenance dialysis. The study consists of three parts: a double-blind, randomized, placebo-controlled study for short-term effects, followed by a single-arm study to assess long-term outcomes over 52 weeks. Participants will receive either MT1013 or a placebo, with specific eligibility criteria related to their dialysis treatment and SHPT diagnosis.
Why it matters
Potential benefit: If successful, this treatment could significantly improve the management of secondary hyperparathyroidism in patients on dialysis.
How similar studies have gone: Other studies have explored treatments for secondary hyperparathyroidism, but the specific approach with MT1013 is novel.
Who can join: the full rules
Show full inclusion / exclusion criteria
1. Receiving hemodialysis 3 times weekly for at least 3 months, and have adequate hemodialysis with a delivered Kt/V≥1.2 or urea reduction ratio (URR)≥65% within 4 weeks prior to screening; 2. Dialysis prescription dialysate calcium concentration must be ≥2.25 mEq/L, and stable for at least 4 weeks prior to screening, remain stable for the duration of the study; 3. Diagnosed of Secondary Hyperparathyroidism (SHPT), with averaged iPTH ≥300 pg/ml (42.4pmol/L) 14 days prior to screening; 4. Receiving active vitamin D sterols must have had no more than a maximum dose change of 50% within the 1 month prior to screening, remain stable; 5. Subject receiving calcium supplements, or phosphate binders must have had no more than a maximum dose change of 50% within the 2 weeks prior to screening, remain stable.
Where it's running
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First Affiliated Hospital College of Medicine, Zhejiang University
Hangzhou, Zhejiang, China Recruiting
Study contacts
- Study coordinator: Jiang hua Chen, MD
- Email: chenjianghua@zju.edu.cn
- Phone: +86 - 13905814058
How to take part
- Review the eligibility criteria above with your treating physician.
- Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
- Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.