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Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial | Clinical Trials | Clareo Health

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Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial

NCT06236295•Shanghai Hengrui Pharmaceutical Co., Ltd.

View on ClinicalTrials.gov

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.

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

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

Locations (1)

Peking University People's Hospital

Beijing, Beijing Municipality, China

Key Dates

Start Date

February 20, 2024

Primary Completion Date

December 1, 2025

Completion Date

December 1, 2025

Last Updated

July 10, 2024

Enrollment

303

ACTUAL participants

Conditions

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Interventions

SHR6508

DRUG