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

Last updated: July 9, 2024
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Overall Status: Active - Not Recruiting

Phase

2

Condition

Neoplasm Metastasis

Hyperparathyroidism

Treatment

SHR6508

Clinical Study ID

NCT06236295
SHR6508-202
  • Ages > 18
  • All Genders

Study 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 Criteria

Inclusion

Inclusion Criteria:

  1. Subject is 18 years of age or older

  2. Subject understands the study procedures and agrees to participate in thestudy bygiving 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

Exclusion Criteria:

  1. Subject has received a a history of malignant tumor within 5 years prior toscreening

  2. Subject has a history of unstable angina, congestive heart failure (NYHA class IIIor IV), acute myocardial infarction, coronary angioplasty, or coronary arterialbypass grafting within the past 6 months prior to screening.

  3. Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110mmHg

  4. Allergy to the investigational drug (SHR6508 injection) and any of its components orexcipients

  5. Subject has a history of drug use or excessive alcohol use within 6 months prior toscreening

  6. Female subjects who were pregnant or lactating

  7. Other reasons for not participating as deemed by the investigator

Study Design

Total Participants: 303
Treatment Group(s): 1
Primary Treatment: SHR6508
Phase: 2
Study Start date:
February 20, 2024
Estimated Completion Date:
December 31, 2025

Connect with a study center

  • Peking University People's Hospital

    Beijing, Beijing 100044
    China

    Site Not Available

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