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Completed

NCT Number: NCT06236295

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

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.

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Key information

Conditions

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

SHR6508

Drug

SHR6508 will be administered to all the eligible subjects

Primary outcomes

  1. Incidence and severity of any adverse events that occurred during the clinical study

    Time frame: through study completion, an average of 1 year

Secondary outcomes

  1. Percent change from baseline in predialysis iPTH during the EAP

    Time frame: through study completion, an average of 1 year

  2. Percent change from baseline in predialysis serum cCa during the EAP

    Time frame: through study completion, an average of 1 year

  3. Percent change from baseline in predialysis serum phosphorus during the EAP

    Time frame: through study completion, an average of 1 year

  4. Percent change from baseline in predialysis calcium-phosphorus product during the EAP

    Time frame: through study completion, an average of 1 year

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
Feb 1, 2024
Registry last updated
May 20, 2026

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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