Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 1:48 PM
Ignite Modification Date:
2025-12-24 @ 1:48 PM
NCT ID:
NCT06236295
Eligibility Criteria:
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
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Study:
NCT06236295
Study Brief:
Protocol Section:
NCT06236295