Study of MT1013 for the Treatment of Patients With Secondary Hyperparathyroidism
Recruiting
Phase 3
Interventional Study
Secondary Hyperparathyroidism, Chronic Kidney Disease
No Placebo Group
Every participant receives an active treatment — no one gets a placebo.
Pivotal Trial
This treatment is in the last trial phase before FDA approval.
Prior Safety Data
This treatment has already been tested in at least one earlier human trial.
At a Glance
- Age
- 18 and older
- Sex
- Any
- Trial phase
- Phase 3
- Study type
- Interventional
- Purpose
- Treatment
- Participants needed
- 424 (estimated)
- Sponsor
- Shaanxi Micot Pharmaceutical Technology Co., Ltd. · Industry
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About This Trial
MT1013 is a first-in-class dual-target agonist. This study is a multicenter, randomized, double-blind, double-dummy phase III clinical study being conducetd to evaluate the efficacy and safety of MT1013 compared with active control cinacalcet in secondary hyperparathyroidism patients on maintenance dialysis. Subjects will be 1:1 randomized to receive MT1013 or cinacalcet for 26 weeks. Evaluations …
Trial Locations
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Eligibility Criteria
Inclusion Criteria:
1. Participants capable of understanding written information ,willing to participate in, and provide a written informed consent;
2. Male or female, at least 18 years old, 18 kg/m\^2 ≤BMI≤35 kg/m\^2;
3. Receiving regular maintenance dialysis 3 times a week for at least 12 weeks p…
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