UnknownPhase 2

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

China303 participantsStarted 2024-02-20

Plain-language 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.

Who can participate

Age range18 Years

SexALL

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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

What they're measuring

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

Timeframe: through study completion, an average of 1 year

Trial details

NCT IDNCT06236295

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-12

View on ClinicalTrials.gov More Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis trials