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Completed

NCT Number: NCT06434961

The Trial of SHR6508 in 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.

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Key information

Conditions

Secondary Hyperparathyroidism Endocrine System Diseases Hyperparathyroidism Hyperparathyroidism, Secondary Parathyroid Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 3

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Who can participate

Healthy volunteers accepted: No

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

Inclusion criteria

  • Able and willing to provide a written informed consent
  • Diagnosed with end stage renal disease receiving maintenance hemodialysis
  • Male or female
  • Meet the Body Mass Index standard
  • Stably use of concomitant medication of other therapies of SHPT
  • Meet the standard of iPTH level, cCa

Exclusion criteria

  • Subjects with a history of malignant tumor
  • Subjects with neuropsychiatric diseases
  • Subjects with a history of cardiovascular diseases
  • Subjects with gastrointestinal diseases
  • Subjects with a history of surgery
  • Subjects with a history of blood loss
  • Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
  • Subjects with a treatment history of similar drugs
  • Allergic to a drug ingredient or component
  • Pregnant or nursing women
  • No birth control during the specified period of time
  • Subject with a history of alcohol abuse and drug abuse
  • Participated in clinical trials of other drugs
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

SHR6508 plus oral placebo tablets

Drug

SHR6508 plus oral placebo tablets

Cinacalcet plus intravenous placebo

Drug

Cinacalcet plus intravenous placebo

Primary outcomes

  1. 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.

Secondary outcomes

  1. 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.

  2. 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)

  3. 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.

  4. 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.

  5. 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)

  6. 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.

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

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

Important dates

Study start
2024
Primary completion
2025
Study completion
2025
First posted
May 30, 2024
Registry last updated
Dec 12, 2025

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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