Secondary HyperparathyroidismPhase 1NCT05221008
A Trial of SHR6508 in Secondary Hyperparathyroidism
A Phase 1 study of Secondary Hyperparathyroidism, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
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 Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Secondary Hyperparathyroidism
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 54 participants
- Where
- 1 siteChina
- Study dates
- 10 Mar 2022to 2 Aug 2023
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Show all 16Show fewer
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: 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
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- SHR6508；Placebo
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6508；PlaceboDrug
Group A:SHR6508 low dose
SHR6508；PlaceboDrug
Group B:SHR6508 medium dose
SHR6508；PlaceboDrug
Group C:SHR6508 high dose
SHR6508；PlaceboDrug
Group D:SHR6508 high dose(single dose)
| Study group | Role | What they receive |
|---|---|---|
| group A | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline Receives: Drug: SHR6508；Placebo |
| group B | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline Receives: Drug: SHR6508；Placebo |
| group C | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline Receives: Drug: SHR6508；Placebo |
| group D | Experimental | Experimental: SHR6508 Placebo Comparator: normal saline Receives: Drug: SHR6508；Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Tmax, Time of maximum observed concentration.
Measured: 0 hour to 43 hours after first dose administration
Cmax, Maximum observed concentration.
Measured: 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.
Measured: 0 hour to 43 hours after first dose administration
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
Measured: 0 hour to 43 hours after first dose administration
t1/2z, Terminal elimination half-life
Measured: 0 hour to 43 hours after first dose administration
CLz, Total Body Clearance
Measured: 0 hour to 43 hours after first dose administration
Vz, Volume of distribution based on the terminal phase
Measured: 0 hour to 43 hours after first dose administration
MRT0-t, Mean residence time from time zero to the last measurable concentration.
Measured: 0 hour to 43 hours after first dose administration
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time
Measured: 0 hour to 43 hours after first dose administration
Cmax,ss : Maximum observed concentration at steady-state.
Measured: Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration at steady-state
Measured: Day1-Day29(if reach steady-state)
Cav : Average concentration
Measured: 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.
Measured: Day1-Day29(if reach steady-state)
AUC0-∞,ss, Area under the concentration-time curve from time 0 extrapolated to infinite time at steady-state.
Measured: Day1-Day29(if reach steady-state)
Tmax,ss, Time of maximum observed concentration at steady-state.
Measured: Day1-Day29(if reach steady-state)
t1/2z,ss, Terminal elimination half-life at steady-state
Measured: Day1-Day29(if reach steady-state)
CLss, Total Body Clearance at steady-state.
Measured: Day1-Day29(if reach steady-state)
Vss, Volume of distribution based on the terminal phase at steady-state.
Measured: Day1-Day29(if reach steady-state)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
Measured: Day1-Day29(if reach steady-state)
DF: Degree of Fluctuation
Measured: Day1-Day29(if reach steady-state)
Accumulation Ratio
Measured: Day1-Day29(if reach steady-state)
Secondary outcomes (5)
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
iPTH, FGF23 and BSAP were tested at a central laboratory.
Measured: 0 hour to 43 hours after first dose administration
Change From Baseline to End of Study in serum iPTH, cCa, P, FGF23 and BSAP
iPTH, FGF23 and BSAP were tested at a central laboratory.
Measured: Day1 to Day29
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
iPTH was tested at a central laboratory.
Measured: Day1 to Day29
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory
Measured: Day1 to Day29
Participants With Treatment-Emergent Adverse Events (TEAEs)
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Measured: Day1 to End of Study, End of Study is about Day55
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Feb 2022
- Study start10 Mar 2022
- Primary completion7 Jul 2023
- Study completion2 Aug 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary HyperparathyroidismStudies of the same condition, open and under way.
- More trials run by Shanghai Hengrui Pharmaceutical Co., Ltd.The sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- SHR6508 compared with placebo
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 54 participants (actual)
Sponsor and investigators
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05221008
- Sponsor's protocol ID
- SHR6508-102
- Status last verified
- Jul 2023
- First submitted
- 7 Jan 2022
- Last updated
- 8 Aug 2023
- Results posted
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Undecided
Study at a glance
From the registry record, last updated by the sponsor on 8 Aug 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study on Tolerability, Pharmacokinetics and Pharmacodynamics of SHR6508 in Chinese Patients With Secondary Hyperparathyroidism of Chronic Kidney Disease Treated by Maintenance Hemodialysis
- ClinicalTrials.gov ID
- NCT05221008
- Acronym / sponsor ID
- SHR6508-102
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 54 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 10 Mar 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 2 Aug 2023 (actual)
- First posted
- 2 Feb 2022 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 4
- Model description
- SHR6508 compared with placebo
| Arm | Type | Receives |
|---|---|---|
| group A | Experimental | Drug: SHR6508；PlaceboExperimental: SHR6508 Placebo Comparator: normal saline |
| group B | Experimental | Drug: SHR6508；PlaceboExperimental: SHR6508 Placebo Comparator: normal saline |
| group C | Experimental | Drug: SHR6508；PlaceboExperimental: SHR6508 Placebo Comparator: normal saline |
| group D | Experimental | Drug: SHR6508；PlaceboExperimental: SHR6508 Placebo Comparator: normal saline |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- 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
Key exclusion criteria (16 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| SHR6508；PlaceboGroup A:SHR6508 low dose | Drug | group A |
| SHR6508；PlaceboGroup B:SHR6508 medium dose | Drug | group B |
| SHR6508；PlaceboGroup C:SHR6508 high dose | Drug | group C |
| SHR6508；PlaceboGroup D:SHR6508 high dose(single dose) | Drug | group D |
Primary outcome
Tmax, Time of maximum observed concentration.
Time frame: 0 hour to 43 hours after first dose administration
Cmax, Maximum observed concentration.
Time frame: 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
AUC0-∞, Area under the curve from time 0 extrapolated to infinite time
Time frame: 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
CLz, Total Body Clearance
Time frame: 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
MRT0-t, Mean residence time from time zero to the last measurable concentration.
Time frame: 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
Cmax,ss : Maximum observed concentration at steady-state.
Time frame: Day1-Day29(if reach steady-state)
Cmin,ss : Minimum observed concentration at steady-state
Time frame: Day1-Day29(if reach steady-state)
Cav : Average concentration
Time frame: 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)
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)
Tmax,ss, Time of maximum observed concentration at steady-state.
Time frame: Day1-Day29(if reach steady-state)
t1/2z,ss, Terminal elimination half-life at steady-state
Time frame: Day1-Day29(if reach steady-state)
CLss, Total Body Clearance at steady-state.
Time frame: 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)
MRT0-∞, Mean residence time from time 0 extrapolated to infinite time.
Time frame: Day1-Day29(if reach steady-state)
DF: Degree of Fluctuation
Time frame: Day1-Day29(if reach steady-state)
Accumulation Ratio
Time frame: Day1-Day29(if reach steady-state)
5 secondary outcomes
Change From Baseline in serum iPTH, cCa, P, FGF23 and BSAP
Time frame: 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
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
Time frame: Day1 to Day29
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
Time frame: Day1 to Day29
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day1 to End of Study, End of Study is about Day55
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Aug 2023.
- Individual participant dataSharing planned: Undecided
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study of Secondary Hyperparathyroidism, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 16 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 8 Aug 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Tmax, Time of maximum observed concentration. (time frame: 0 hour to 43 hours after first dose administration). The study lists 21 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 8 Aug 2023.