Status:
COMPLETED
A Trial of SHR6508 in Secondary Hyperparathyroidism
Lead Sponsor:
Shanghai Hengrui Pharmaceutical Co., Ltd.
Conditions:
Secondary Hyperparathyroidism
Eligibility:
All Genders
18-70 years
Phase:
PHASE1
Brief Summary
The study is being conducted to evaluate the tolerability, pharmacokinetics and pharmacodynamics of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by...
Eligibility Criteria
Inclusion
- 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
- Conform to the ASA Physical Status Classification
- Stably use of concomitant medication of other therapies of SHPT
- Meet the standard of iPTH level, cCa and HB
Exclusion
- 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
- Subjects with a history of parathyroidectomy or planned during the study
- Subjects with a history of kidney transplant or planned during the study
- Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin, platelet counts.
- 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 (received experimental drugs)
- The investigators determined that other conditions were inappropriate for participation in this clinical trial
Key Trial Info
Start Date :
March 10 2022
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
August 2 2023
Estimated Enrollment :
54 Patients enrolled
Trial Details
Trial ID
NCT05221008
Start Date
March 10 2022
End Date
August 2 2023
Last Update
August 8 2023
Active Locations (1)
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1
Guangdong Provincial People's Hospital
Guangzhou, Guangdong, China