Search / Trial NCT06236295

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

Launched by SHANGHAI HENGRUI PHARMACEUTICAL CO., LTD. · Jan 23, 2024

Trial Information

Current as of October 07, 2024

Unknown status

Keywords

Description

No description provided

Gender

ALL

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

About Shanghai Hengrui Pharmaceutical Co., Ltd.

Shanghai Hengrui Pharmaceutical Co., Ltd. is a leading global pharmaceutical company based in China, recognized for its commitment to innovative research and development in the fields of oncology, anesthesiology, and imaging. Established in 1993, Hengrui has rapidly advanced its portfolio of drug candidates, focusing on both small molecules and biologics to address unmet medical needs. The company emphasizes quality and compliance in its manufacturing processes and is dedicated to enhancing patient outcomes through the development of novel therapeutics. With a strong presence in international markets, Hengrui actively engages in clinical trials to bring cutting-edge treatments to patients worldwide.

Locations

Beijing, Beijing, China

Beijing, Beijing, China

People applied

Timeline

First submit

Trial launched

Trial updated

Estimated completion

Not reported

Discussion 0