NCT06236295CompletedPhase 2
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
Source: ClinicalTrials.gov · Last updated 20 May 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 2
- Study type
- Interventional
- Enrollment
- 303 (actual)
- First submitted
- 9 Jan 2024
- Start date
- 20 Feb 2024
- Primary completion date
- 13 Nov 2025
- Lead sponsor
- Shanghai Hengrui Pharmaceutical Co., Ltd.
- Diseases
- Chronic kidney disease
- NCT number
- NCT06236295
What you commit to
- Study type: Interventional · Phase 2
- Participants enrolled: 303
- From 20 Feb 2024 to the primary completion date, 13 Nov 2025
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Prior treatment
- 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.
- 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
Other illness
- Subject has received a a history of malignant tumor within 5 years prior to screening
Other
- Postdialysis systolic blood pressure\>180 mmHg and/or diastolic blood pressure\>110 mmHg
- Female subjects who were pregnant or lactating
- Other reasons for not participating as deemed by the investigator
Who the study is looking for
- 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
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Peking University People's Hospital Coordinator of this site? Confirm its status | Beijing | China | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.