Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Conditions
Brief summary
This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.
Interventions
DRUGSHR6508
SHR6508 will be administered to all the eligible subjects
Sponsors
Shanghai Hengrui Pharmaceutical Co., Ltd.
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subject is 18 years of age or older 2. Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent. 3. Subject must be receiving regular hemodialysis for at least 12 weeks 4. BMI ≥18 kg/m2 and ≤35 kg/m2 5. iPTH≥ 300pg/ mL
Exclusion criteria
1. Subject has received a a history of malignant tumor within 5 years prior to screening 2. Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening. 3. Postdialysis systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg 4. Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients 5. Subject has a history of drug use or excessive alcohol use within 6 months prior to screening 6. Female subjects who were pregnant or lactating 7. Other reasons for not participating as deemed by the investigator
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Incidence and severity of any adverse events that occurred during the clinical study | through study completion, an average of 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Percent change from baseline in predialysis iPTH during the EAP | through study completion, an average of 1 year |
| Percent change from baseline in predialysis serum cCa during the EAP | through study completion, an average of 1 year |
| Percent change from baseline in predialysis serum phosphorus during the EAP | through study completion, an average of 1 year |
| Percent change from baseline in predialysis calcium-phosphorus product during the EAP | through study completion, an average of 1 year |
Countries
China
Outcome results
None listed