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

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Hengrui Medicine

Status and phase

Enrolling
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

300 estimated 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

Trial design

300 participants in 1 patient group

SHR6508
Experimental group
Treatment:
Drug: SHR6508

Trial contacts and locations

0

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Central trial contact

Yun Jin

Data sourced from clinicaltrials.gov

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