To hear about similar clinical trials, please enter your email below
Trial Title:
Investigating the Safety and Efficacy of SHR6508 Injection in the Treatment of Secondary Hyperparathyroidism in Hemodialysis Patients : A Multicenter, Long-term Clinical Trial
NCT ID:
NCT06236295
Condition:
Secondary Hyperparathyroidism (SHPT) in Subjects With Chronic Kidney Disease (CKD) on Hemodialysis
Conditions: Official terms:
Neoplasm Metastasis
Kidney Diseases
Renal Insufficiency, Chronic
Hyperparathyroidism
Hyperparathyroidism, Secondary
Study type:
Interventional
Study phase:
Phase 2
Overall status:
Active, not recruiting
Study design:
Allocation:
N/A
Intervention model:
Single Group Assignment
Primary purpose:
Treatment
Masking:
None (Open Label)
Intervention:
Intervention type:
Drug
Intervention name:
SHR6508
Description:
SHR6508 will be administered to all the eligible subjects
Arm group label:
SHR6508
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Subject is 18 years of age or older
2. Subject understands the study procedures and agrees to participate in thestudy by
giving written informed consent.
3. Subject must be receiving regular hemodialysis for at least 12 weeks
4. BMI ≥18 kg/m2 and ≤35 kg/m2
5. iPTH≥ 300pg/ mL
Exclusion Criteria:
1. Subject has received a a history of malignant tumor within 5 years prior to
screening
2. 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.
3. Postdialysis systolic blood pressure>180 mmHg and/or diastolic blood pressure>110
mmHg
4. Allergy to the investigational drug (SHR6508 injection) and any of its components or
excipients
5. Subject has a history of drug use or excessive alcohol use within 6 months prior to
screening
6. Female subjects who were pregnant or lactating
7. Other reasons for not participating as deemed by the investigator
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Peking University People's Hospital
Address:
City:
Beijing
Zip:
100044
Country:
China
Start date:
February 20, 2024
Completion date:
December 2025
Lead sponsor:
Agency:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Agency class:
Industry
Source:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Record processing date:
ClinicalTrials.gov processed this data on November 12, 2024
Source: ClinicalTrials.gov page:
https://clinicaltrials.gov/ct2/show/NCT06236295
