The Trial of SHR6508 in Secondary Hyperparathyroidism

December 11, 2025 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

The study is being conducted to evaluate the efficacy and safety of SHR6508 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

498

Phase

  • Phase 3

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
    • Guangdong
      • Guangzhou, Guangdong, China, 510000
        • Guangdong Provincial 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. Able and willing to provide a written informed consent
  2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
  3. Male or female
  4. Meet the Body Mass Index standard
  5. Stably use of concomitant medication of other therapies of SHPT
  6. Meet the standard of iPTH level, cCa

Exclusion Criteria:

  1. Subjects with a history of malignant tumor
  2. Subjects with neuropsychiatric diseases
  3. Subjects with a history of cardiovascular diseases
  4. Subjects with gastrointestinal diseases
  5. Subjects with a history of surgery
  6. Subjects with a history of blood loss
  7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
  8. Subjects with a treatment history of similar drugs
  9. Allergic to a drug ingredient or component
  10. Pregnant or nursing women
  11. No birth control during the specified period of time
  12. Subject with a history of alcohol abuse and drug abuse
  13. Participated in clinical trials of other drugs
  14. The investigators determined that other conditions were inappropriate for participation in this clinical trial

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: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Quadruple

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Treatment group
Drug: SHR6508 plus oral placebo tablets
SHR6508 plus oral placebo tablets
Active Comparator: Active Control group
Drug: Cinacalcet plus intravenous placebo
Cinacalcet plus intravenous placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
Time Frame: efficacy assessment period, defined as Week 20-27
iPTH was tested at a central laboratory.
efficacy assessment period, defined as Week 20-27

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
Time Frame: efficacy assessment period, defined as Week 20-27
iPTH was tested at a central laboratory.
efficacy assessment period, defined as Week 20-27
Incidence of nausea and vomiting events
Time Frame: Day1 to End of Treatment, End of Treatment is about Week 27
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Day1 to End of Treatment, End of Treatment is about Week 27
Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline
Time Frame: efficacy assessment period, defined as Week 20-27
iPTH was tested at a central laboratory.
efficacy assessment period, defined as Week 20-27
Change From Baseline in serum cCa and P
Time Frame: efficacy assessment period, defined as Week 20-27
cCa and P were tested at a central laboratory.
efficacy assessment period, defined as Week 20-27
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time Frame: Day1 to End of Study, End of Study is about Week 31
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Day1 to End of Study, End of Study is about Week 31
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Time Frame: Day1 to End of Study, End of Study is about Week 31
Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.
Day1 to End of Study, End of Study is about Week 31

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)

June 14, 2024

Primary Completion (Actual)

September 29, 2025

Study Completion (Actual)

November 11, 2025

Study Registration Dates

First Submitted

May 24, 2024

First Submitted That Met QC Criteria

May 24, 2024

First Posted (Actual)

May 30, 2024

Study Record Updates

Last Update Posted (Actual)

December 12, 2025

Last Update Submitted That Met QC Criteria

December 11, 2025

Last Verified

December 1, 2025

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • SHR6508-301

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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