A Trial of SHR6508 in Secondary Hyperparathyroidism

August 7, 2023 updated by: Shanghai Hengrui Pharmaceutical Co., Ltd.

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

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

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
54

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 1

Contacts and Locations

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

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China
        • 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

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

18 years to 70 years (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 stable hemodialysis
  3. Male or female
  4. Meet the Body Mass Index standard
  5. Conform to the ASA Physical Status Classification
  6. Stably use of concomitant medication of other therapies of SHPT
  7. Meet the standard of iPTH level, cCa and HB

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. Subjects with a history of parathyroidectomy or planned during the study
  8. Subjects with a history of kidney transplant or planned during the study
  9. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
  10. Subjects with a treatment history of similar drugs
  11. Allergic to a drug ingredient or component
  12. Pregnant or nursing women
  13. No birth control during the specified period of time
  14. Subject with a history of alcohol abuse and drug abuse
  15. Participated in clinical trials of other drugs (received experimental drugs)
  16. 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

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: group A
Experimental: SHR6508 Placebo Comparator: normal saline
Drug: SHR6508；Placebo
Group A:SHR6508 low dose
Drug: SHR6508；Placebo
Group B:SHR6508 medium dose
Drug: SHR6508；Placebo
Group C:SHR6508 high dose
Drug: SHR6508；Placebo
Group D:SHR6508 high dose(single dose)
Experimental: group B
Experimental: SHR6508 Placebo Comparator: normal saline
Drug: SHR6508；Placebo
Group A:SHR6508 low dose
Drug: SHR6508；Placebo
Group B:SHR6508 medium dose
Drug: SHR6508；Placebo
Group C:SHR6508 high dose
Drug: SHR6508；Placebo
Group D:SHR6508 high dose(single dose)
Experimental: group C
Experimental: SHR6508 Placebo Comparator: normal saline
Drug: SHR6508；Placebo
Group A:SHR6508 low dose
Drug: SHR6508；Placebo
Group B:SHR6508 medium dose
Drug: SHR6508；Placebo
Group C:SHR6508 high dose
Drug: SHR6508；Placebo
Group D:SHR6508 high dose(single dose)
Experimental: group D
Experimental: SHR6508 Placebo Comparator: normal saline
Drug: SHR6508；Placebo
Group A:SHR6508 low dose
Drug: SHR6508；Placebo
Group B:SHR6508 medium dose
Drug: SHR6508；Placebo
Group C:SHR6508 high dose
Drug: SHR6508；Placebo
Group D:SHR6508 high dose(single dose)

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Tmax, Time of maximum observed concentration.
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
Cmax, Maximum observed concentration.
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
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
0 hour to 43 hours after first dose administration
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
t1/2z, Terminal elimination half-life
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
CLz, Total Body Clearance
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
Vz, Volume of distribution based on the terminal phase
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
MRT0-t, Mean residence time from time zero to the last measurable concentration.
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
Time Frame: 0 hour to 43 hours after first dose administration
0 hour to 43 hours after first dose administration
Cmax,ss : Maximum observed concentration at steady-state.
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration at steady-state
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
Cav : Average concentration
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
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)
Day1-Day29(if reach steady-state)
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)
Day1-Day29(if reach steady-state)
Tmax,ss, Time of maximum observed concentration at steady-state.
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
t1/2z,ss, Terminal elimination half-life at steady-state
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
CLss, Total Body Clearance at steady-state.
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
Vss, Volume of distribution based on the terminal phase at steady-state.
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
DF: Degree of Fluctuation
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)
Accumulation Ratio
Time Frame: Day1-Day29(if reach steady-state)
Day1-Day29(if reach steady-state)

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
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.
0 hour to 43 hours after first dose administration
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.
Day1 to Day29
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.
Day1 to Day29
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
Day1 to Day29
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)
Day1 to End of Study, End of Study is about Day55

Collaborators and Investigators

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

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
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)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
March 10, 2022

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
July 7, 2023

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
August 2, 2023

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
January 7, 2022

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 20, 2022

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
February 2, 2022

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
August 8, 2023

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
August 7, 2023

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
July 1, 2023

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • SHR6508-102

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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