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

Hengrui Medicine

Status and phase

Active, not recruiting

Phase 2

Conditions

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

Treatments

Drug: SHR6508

Study type

Interventional

Funder types

Industry

Identifiers

NCT06236295

SHR6508-202

Details and patient eligibility

About

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.

Enrollment

303 patients

Sex

All

Ages

18+ years old

Volunteers

No Healthy Volunteers

Inclusion criteria

Subject is 18 years of age or older
Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
Subject must be receiving regular hemodialysis for at least 12 weeks
BMI ≥18 kg/m2 and ≤35 kg/m2
iPTH≥ 300pg/ mL

Exclusion criteria

Subject has received a a history of malignant tumor within 5 years prior to screening
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.
Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg
Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
Female subjects who were pregnant or lactating
Other reasons for not participating as deemed by the investigator