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

NCT06236295 | Unknown Phase 2

• 1 other identifier: SHR6508-202
• Study Type: interventional
• Target: 303
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis

Outcome Measures

Primary Outcomes (1)

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

  through study completion, an average of 1 year

Secondary Outcomes (4)

• Percent change from baseline in predialysis iPTH during the EAP

  through study completion, an average of 1 year

• Percent change from baseline in predialysis serum cCa during the EAP

  through study completion, an average of 1 year

• Percent change from baseline in predialysis serum phosphorus during the EAP

  through study completion, an average of 1 year

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

  through study completion, an average of 1 year

Study Arms (1)

SHR6508

EXPERIMENTAL

Drug: SHR6508

Interventions

SHR6508 DRUG

SHR6508 will be administered to all the eligible subjects

SHR6508

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Peking University People's Hospital

Beijing, Beijing Municipality, 100044, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: January 9, 2024
• First Posted: February 1, 2024
• Study Start: February 20, 2024
• Primary Completion: December 1, 2025
• Study Completion: December 1, 2025
• Last Updated: July 10, 2024

Record last verified: 2024-01

Locations

CN (1)