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Completed

NCT Number: NCT05221008

A Trial of SHR6508 in Secondary Hyperparathyroidism

The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for 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–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 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 stable hemodialysis
  • Male or female
  • Meet the Body Mass Index standard
  • Conform to the ASA Physical Status Classification
  • Stably use of concomitant medication of other therapies of SHPT
  • Meet the standard of iPTH level, cCa and HB

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
  • Subjects with a history of parathyroidectomy or planned during the study
  • Subjects with a history of kidney transplant or planned during the study
  • Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
  • 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 (received experimental drugs)
  • The investigators determined that other conditions were inappropriate for participation in this clinical trial

Treatment and study plan

SHR6508；Placebo

Drug

Group A:SHR6508 low dose

Primary outcomes

  1. Tmax, Time of maximum observed concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  2. Cmax, Maximum observed concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  3. AUC0-t, Area under the concentration-time curve from time zero to the last measurable concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  4. AUC0-∞, Area under the curve from time 0 extrapolated to infinite time

    Time frame: 0 hour to 43 hours after first dose administration

  5. t1/2z, Terminal elimination half-life

    Time frame: 0 hour to 43 hours after first dose administration

  6. CLz, Total Body Clearance

    Time frame: 0 hour to 43 hours after first dose administration

  7. Vz, Volume of distribution based on the terminal phase

    Time frame: 0 hour to 43 hours after first dose administration

  8. MRT0-t, Mean residence time from time zero to the last measurable concentration.

    Time frame: 0 hour to 43 hours after first dose administration

  9. MRT0-∞, Mean residence time from time 0 extrapolated to infinite time

    Time frame: 0 hour to 43 hours after first dose administration

  10. Cmax,ss : Maximum observed concentration at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  11. Cmin,ss : Minimum observed concentration at steady-state

    Time frame: Day1-Day29(if reach steady-state)

  12. Cav : Average concentration

    Time frame: Day1-Day29(if reach steady-state)

  13. AUC0-t,ss, Area under the concentration-time curve from time zero to the last measurable concentration at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  14. AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  15. Tmax,ss, Time of maximum observed concentration at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  16. t1/2z,ss, Terminal elimination half-life at steady-state

    Time frame: Day1-Day29(if reach steady-state)

  17. CLss, Total Body Clearance at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  18. Vss, Volume of distribution based on the terminal phase at steady-state.

    Time frame: Day1-Day29(if reach steady-state)

  19. MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.

    Time frame: Day1-Day29(if reach steady-state)

  20. DF: Degree of Fluctuation

    Time frame: Day1-Day29(if reach steady-state)

  21. Accumulation Ratio

    Time frame: Day1-Day29(if reach steady-state)

Secondary outcomes

  1. Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP

    Time frame: 0 hour to 43 hours after first dose administration

    iPTH, FGF23 and BSAP were tested at a central laboratory.

  2. Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP

    Time frame: Day1 to Day29

    iPTH, FGF23 and BSAP were tested at a central laboratory.

  3. Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline

    Time frame: Day1 to Day29

    iPTH was tested at a central laboratory.

  4. Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline

    Time frame: Day1 to Day29

    iPTH was 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 Day55

    Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

Sponsors and collaborators

Lead sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Industry

Registry information

Official study title

Study on Tolerability, Pharmacokinetics and Pharmacodynamics of SHR6508 in Chinese Patients With Secondary Hyperparathyroidism of Chronic Kidney Disease Treated by Maintenance Hemodialysis

Important dates

Study start
2022
Primary completion
2023
Study completion
2023
First posted
Feb 2, 2022
Registry last updated
Aug 8, 2023

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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