Secondary HyperparathyroidismPhase 2NCT05663411
A Study of SHR6508 in Secondary Hyperparathyroidism
A Phase 2 study testing SHR6508 and Cinacalcet in people with Secondary Hyperparathyroidism, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
The study is being conducted to evaluate the efficacy and safety 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 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism
- What is being tested?
- SHR6508 and Cinacalcet
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 75 participants
- Where
- 1 siteChina
- Study dates
- 24 Feb 2023to 30 Nov 2023
- Phase
- Phase 2
- 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 years and older
- 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
- 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 15Show fewer
- Subjects with a history of kidney transplant
- 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
Trial locations and contacts
1 site in 1 country.
About this study
Official title: An Open-label, Randomized, Active-Controlled Dose Titration 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 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- SHR6508, Cinacalcet
- Medical subject headings
- Hyperparathyroidism, Secondary
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
SHR6508Drug
SHR6508
SHR6508Drug
SHR6508
CinacalcetDrug
Cinacalcet
| Study group | Role | What they receive |
|---|---|---|
| Treatment group A: SHR6508 | Experimental | Not described Receives: Drug: SHR6508 |
| Treatment group B: SHR6508 | Experimental | Not described Receives: Drug: SHR6508 |
| Treatment group C: Cinacalcet | Active comparator | Not described Receives: Drug: Cinacalcet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change From Baseline in serum iPTH
iPTH was tested at a central laboratory.
Measured: Baseline and the efficacy period, defined as Week 16
Secondary outcomes (5)
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
iPTH was tested at a central laboratory.
Measured: Baseline and the efficacy period, defined as Week 16
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory.
Measured: Baseline and the efficacy period, defined as Week 16
Change From Baseline in serum cCa and P
cCa and P were tested at a local laboratory.
Measured: Baseline and the efficacy period, defined as Week 16
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 Week 20
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Measured: Day1 to End of Study, End of Study is about Week 20
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Dec 2022
- Study start24 Feb 2023
- Primary completion31 Oct 2023 (estimated)
- Study completion30 Nov 2023 (estimated)
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 75 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
- NCT05663411
- Sponsor's protocol ID
- SHR6508-201
- Status last verified
- Nov 2022
- First submitted
- 14 Dec 2022
- Last updated
- 18 Jun 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 18 Jun 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT05663411
- Acronym / sponsor ID
- SHR6508-201
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 24 Feb 2023 (actual)
- Primary completion
- 31 Oct 2023 (estimated)
- Study completion
- 30 Nov 2023 (estimated)
- First posted
- 23 Dec 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 efficacy and safety 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
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Treatment group A: SHR6508 | Experimental | Drug: SHR6508 |
| Treatment group B: SHR6508 | Experimental | Drug: SHR6508 |
| Treatment group C: Cinacalcet | Active comparator | Drug: Cinacalcet |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 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
- Stably use of concomitant medication of other therapies of SHPT
Key exclusion criteria (15 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 |
|---|---|---|
| SHR6508SHR6508 | Drug | Treatment group A: SHR6508 |
| SHR6508SHR6508 | Drug | Treatment group B: SHR6508 |
| CinacalcetCinacalcet | Drug | Treatment group C: Cinacalcet |
Primary outcome
Change From Baseline in serum iPTH
Time frame: Baseline and the efficacy period, defined as Week 16
iPTH was tested at a central laboratory.
5 secondary outcomes
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
Time frame: Baseline and the efficacy period, defined as Week 16
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
Time frame: Baseline and the efficacy period, defined as Week 16
Change From Baseline in serum cCa and P
Time frame: Baseline and the efficacy period, defined as Week 16
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day1 to End of Study, End of Study is about Week 20
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Time frame: Day1 to End of Study, End of Study is about Week 20
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Jun 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 2 study testing SHR6508 and Cinacalcet in people with 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 6 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 18 Jun 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
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?
Change From Baseline in serum iPTH (time frame: Baseline and the efficacy period, defined as Week 16). 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 18 Jun 2023.