Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on HemodialysisPhase 2NCT06236295
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
A Phase 2 study testing SHR6508 in people with Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis, run by Shanghai Hengrui Pharmaceutical Co., Ltd. at 1 site in China.
Trial summary
This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- What is being tested?
- SHR6508
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 303 participants
- Where
- 1 siteChina
- Study dates
- 20 Feb 2024to 13 Nov 2025
- 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
- Subject is 18 years of age or older
- Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
- Subject must be receiving regular hemodialysis for at least 12 weeks
- BMI ≥18 kg/m2 and ≤35 kg/m2
- iPTH≥ 300pg/ mL
Who cannot join
- Subject has received a a history of malignant tumor within 5 years prior to screening
- Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg
- Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
- Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
- Female subjects who were pregnant or lactating
- Other reasons for not participating as deemed by the investigator
Trial locations and contacts
1 site in 1 country.
China1 site
Peking University People's Hospital
Beijing, Beijing Municipality, 100044
About this study
This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Being tested
- SHR6508
- 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 will be administered to all the eligible subjects
| Study group | Role | What they receive |
|---|---|---|
| SHR6508 | Experimental | Not described Receives: Drug: SHR6508 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence and severity of any adverse events that occurred during the clinical study
Measured: through study completion, an average of 1 year
Secondary outcomes (4)
Percent change from baseline in predialysis iPTH during the EAP
Measured: through study completion, an average of 1 year
Percent change from baseline in predialysis serum cCa during the EAP
Measured: through study completion, an average of 1 year
Percent change from baseline in predialysis serum phosphorus during the EAP
Measured: through study completion, an average of 1 year
Percent change from baseline in predialysis calcium-phosphorus product during the EAP
Measured: through study completion, an average of 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Feb 2024
- Study start20 Feb 2024
- Primary completion13 Nov 2025
- Study completion13 Nov 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on HemodialysisStudies 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 303 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
- NCT06236295
- Sponsor's protocol ID
- SHR6508-202
- Status last verified
- May 2026
- First submitted
- 9 Jan 2024
- Last updated
- 20 May 2026
- 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 20 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
- ClinicalTrials.gov ID
- NCT06236295
- Acronym / sponsor ID
- SHR6508-202
- Conditions
- Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 303 participants (actual)
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.Industry (pharma, biotech, devices)
- Study start
- 20 Feb 2024 (actual)
- Primary completion
- 13 Nov 2025 (actual)
- Study completion
- 13 Nov 2025 (actual)
- First posted
- 1 Feb 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.
This is a multicenter, single-arm, long-term safety and tolerability trial. A total of 300 subjects with chronic kidney disease on hemodialysis are planned to be enrolled.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| SHR6508 | Experimental | Drug: SHR6508 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Subject is 18 years of age or older
- Subject understands the study procedures and agrees to participate in thestudy by giving written informed consent.
- Subject must be receiving regular hemodialysis for at least 12 weeks
- BMI ≥18 kg/m2 and ≤35 kg/m2
- iPTH≥ 300pg/ mL
Key exclusion criteria (7 listed)
- Subject has received a a history of malignant tumor within 5 years prior to screening
- Subject has a history of unstable angina, congestive heart failure (NYHA class III or IV), acute myocardial infarction, coronary angioplasty, or coronary arterial bypass grafting within the past 6 months prior to screening.
- Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110 mmHg
- Allergy to the investigational drug (SHR6508 injection) and any of its components or excipients
- Subject has a history of drug use or excessive alcohol use within 6 months prior to screening
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 will be administered to all the eligible subjects | Drug | SHR6508 |
Primary outcome
Incidence and severity of any adverse events that occurred during the clinical study
Time frame: through study completion, an average of 1 year
4 secondary outcomes
Percent change from baseline in predialysis iPTH during the EAP
Time frame: through study completion, an average of 1 year
Percent change from baseline in predialysis serum cCa during the EAP
Time frame: through study completion, an average of 1 year
Percent change from baseline in predialysis serum phosphorus during the EAP
Time frame: through study completion, an average of 1 year
Percent change from baseline in predialysis calcium-phosphorus product during the EAP
Time frame: through study completion, an average of 1 year
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 20 May 2026.
- Individual participant dataSharing planned: Undecided
Related trials for Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
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Secondary Hyperparathyroidism, Chronic Kidney Disease
RecruitingPhase 2
Study of MT1013 Injection for the Treatment of Secondary Hyperparathyroidism (SHPT) Patients With Chronic Kidney Disease Undergoing Maintenance Dialysis
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
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 in people with Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis, 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 5 inclusion and 7 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 20 May 2026. 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?
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?
Incidence and severity of any adverse events that occurred during the clinical study (time frame: through study completion, an average of 1 year). 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 20 May 2026.