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

May 19, 2026 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.
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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

303

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
    • Beijing Municipality
      • Beijing, Beijing Municipality, China, 100044
        • Peking University People's Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: SHR6508
Drug: SHR6508
SHR6508 will be administered to all the eligible subjects

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Incidence and severity of any adverse events that occurred during the clinical study
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Secondary Outcome Measures

Outcome Measure
Time Frame
Percent change from baseline in predialysis iPTH during the EAP
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Percent change from baseline in predialysis serum cCa during the EAP
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Percent change from baseline in predialysis serum phosphorus during the EAP
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year
Percent change from baseline in predialysis calcium-phosphorus product during the EAP
Time Frame: through study completion, an average of 1 year
through study completion, an average of 1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

February 20, 2024

Primary Completion (Actual)

November 13, 2025

Study Completion (Actual)

November 13, 2025

Study Registration Dates

First Submitted

January 9, 2024

First Submitted That Met QC Criteria

January 23, 2024

First Posted (Actual)

February 1, 2024

Study Record Updates

Last Update Posted (Actual)

May 20, 2026

Last Update Submitted That Met QC Criteria

May 19, 2026

Last Verified

May 1, 2026

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR6508-202

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

UNDECIDED

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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