Secondary HyperparathyroidismPhase 3NCT06434961
The Trial of SHR6508 in Secondary Hyperparathyroidism
A Phase 3 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 efficacy and safety of SHR6508 among 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
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 498 participants
- Where
- 1 siteChina
- Study dates
- 14 Jun 2024to 11 Nov 2025
- Phase
- Phase 3
- 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 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
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 14Show fewer
- 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: A Multicenter, Randomised, Double-blind, Double-dummy 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 among Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
- Conditions
- Secondary Hyperparathyroidism
- Being tested
- SHR6508 plus oral placebo tablets, Cinacalcet plus intravenous 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 plus oral placebo tabletsDrug
SHR6508 plus oral placebo tablets
Cinacalcet plus intravenous placeboDrug
Cinacalcet plus intravenous placebo
| Study group | Role | What they receive |
|---|---|---|
| Treatment group | Experimental | Not described Receives: Drug: SHR6508 plus oral placebo tablets |
| Active Control group | Active comparator | Not described Receives: Drug: Cinacalcet plus intravenous placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline
iPTH was tested at a central laboratory.
Measured: efficacy assessment period, defined as Week 20-27
Secondary outcomes (6)
Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
iPTH was tested at a central laboratory.
Measured: efficacy assessment period, defined as Week 20-27
Incidence of nausea and vomiting events
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Measured: Day1 to End of Treatment, End of Treatment is about Week 27
Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory.
Measured: efficacy assessment period, defined as Week 20-27
Change From Baseline in serum cCa and P
cCa and P were tested at a central laboratory.
Measured: efficacy assessment period, defined as Week 20-27
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 31
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.
Measured: Day1 to End of Study, End of Study is about Week 31
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 May 2024
- Study start14 Jun 2024
- Primary completion29 Sep 2025
- Study completion11 Nov 2025
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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 498 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
- NCT06434961
- Sponsor's protocol ID
- SHR6508-301
- Status last verified
- Dec 2025
- First submitted
- 24 May 2024
- Last updated
- 12 Dec 2025
- 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 12 Dec 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomised, Double-blind, Double-dummy Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
- ClinicalTrials.gov ID
- NCT06434961
- Acronym / sponsor ID
- SHR6508-301
- Conditions
- Secondary Hyperparathyroidism
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 498 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 14 Jun 2024 (actual)
- Primary completion
- 29 Sep 2025 (actual)
- Study completion
- 11 Nov 2025 (actual)
- First posted
- 30 May 2024 (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 among 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
- 2
| Arm | Type | Receives |
|---|---|---|
| Treatment group | Experimental | Drug: SHR6508 plus oral placebo tablets |
| Active Control group | Active comparator | Drug: Cinacalcet plus intravenous placebo |
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 maintenance hemodialysis
- Male or female
- Meet the Body Mass Index standard
- Stably use of concomitant medication of other therapies of SHPT
Key exclusion criteria (14 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 plus oral placebo tabletsSHR6508 plus oral placebo tablets | Drug | Treatment group |
| Cinacalcet plus intravenous placeboCinacalcet plus intravenous placebo | Drug | Active Control group |
Primary outcome
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.
6 secondary outcomes
Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline
Time frame: efficacy assessment period, defined as Week 20-27
Incidence of nausea and vomiting events
Time frame: Day1 to End of Treatment, End of Treatment is about Week 27
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
Change From Baseline in serum cCa and P
Time frame: efficacy assessment period, defined as Week 20-27
Participants With Treatment-Emergent Adverse Events (TEAEs)
Time frame: Day1 to End of Study, End of Study is about Week 31
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Time frame: Day1 to End of Study, End of Study is about Week 31
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 12 Dec 2025.
- 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 3 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 6 inclusion and 14 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 12 Dec 2025. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Proportion of Participants to End of Study whose iPTH decreased by>30% from baseline (time frame: efficacy assessment period, defined as Week 20-27). 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 12 Dec 2025.