A Study of SHR6508 in Secondary Hyperparathyroidism

Study Overview
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Brief Summary
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The study is being conducted to evaluate the efficacy and safety of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.

Official Title
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An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Conditions
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Secondary Hyperparathyroidism

Intervention / Treatment
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* Drug: SHR6508
* Drug: SHR6508
* Drug: Cinacalcet


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Able and willing to provide a written informed consent Diagnosed with end stage renal disease receiving stable hemodialysis Male or female Meet the Body Mass Index standard Stably use of concomitant medication of other therapies of SHPT Meet the standard of iPTH level, cCa and HB Exclusion Criteria: Subjects with a history of malignant tumor Subjects with neuropsychiatric diseases Subjects with a history of cardiovascular diseases Subjects with gastrointestinal diseases Subjects with a history of surgery Subjects with a history of blood loss Subjects with a history of kidney transplant Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin Subjects with a treatment history of similar drugs Allergic to a drug ingredient or component Pregnant or nursing women No birth control during the specified period of time Subject with a history of alcohol abuse and drug abuse Participated in clinical trials of other drugs The investigators determined that other conditions were inappropriate for participation in this clinical trial

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Treatment group A: SHR6508<br> | Drug: SHR6508<br>* SHR6508<br>|
| Experimental: Treatment group B: SHR6508<br> | Drug: SHR6508<br>* SHR6508<br>|
| Active Comparator: Treatment group C: Cinacalcet<br> | Drug: Cinacalcet<br>* Cinacalcet<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Change From Baseline in serum iPTH | iPTH was tested at a central laboratory. | Baseline and the efficacy period, defined as Week 16 | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline | iPTH was tested at a central laboratory. | Baseline and the efficacy period, defined as Week 16 | 
| Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline | iPTH was tested at a central laboratory. | Baseline and the efficacy period, defined as Week 16 | 
| Change From Baseline in serum cCa and P | cCa and P were tested at a local laboratory. | Baseline and the efficacy period, defined as Week 16 | 
| Participants With Treatment-Emergent Adverse Events (TEAEs) | Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA) | Day1 to End of Study, End of Study is about Week 20 | 
| Participants with Anti-SHR6508 Antibody at baseline and postbaseline |  | Day1 to End of Study, End of Study is about Week 20 |