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Trial Title:
The Trial of SHR6508 in Secondary Hyperparathyroidism
NCT ID:
NCT06434961
Condition:
Secondary Hyperparathyroidism
Conditions: Official terms:
Neoplasm Metastasis
Hyperparathyroidism
Hyperparathyroidism, Secondary
Cinacalcet
Study type:
Interventional
Study phase:
Phase 3
Overall status:
Recruiting
Study design:
Allocation:
Randomized
Intervention model:
Parallel Assignment
Primary purpose:
Treatment
Masking:
Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Intervention:
Intervention type:
Drug
Intervention name:
SHR6508 plus oral placebo tablets
Description:
SHR6508 plus oral placebo tablets
Arm group label:
Treatment group
Intervention type:
Drug
Intervention name:
Cinacalcet plus intravenous placebo
Description:
Cinacalcet plus intravenous placebo
Arm group label:
Active Control group
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.
Criteria for eligibility:
Criteria:
Inclusion Criteria:
1. Able and willing to provide a written informed consent
2. Diagnosed with end stage renal disease receiving maintenance hemodialysis
3. Male or female
4. Meet the Body Mass Index standard
5. Stably use of concomitant medication of other therapies of SHPT
6. Meet the standard of iPTH level, cCa
Exclusion Criteria:
1. Subjects with a history of malignant tumor
2. Subjects with neuropsychiatric diseases
3. Subjects with a history of cardiovascular diseases
4. Subjects with gastrointestinal diseases
5. Subjects with a history of surgery
6. Subjects with a history of blood loss
7. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
8. Subjects with a treatment history of similar drugs
9. Allergic to a drug ingredient or component
10. Pregnant or nursing women
11. No birth control during the specified period of time
12. Subject with a history of alcohol abuse and drug abuse
13. Participated in clinical trials of other drugs
14. The investigators determined that other conditions were inappropriate for
participation in this clinical trial
Gender:
All
Minimum age:
18 Years
Maximum age:
N/A
Healthy volunteers:
No
Locations:
Facility:
Name:
Guangdong Provincial People's Hospital
Address:
City:
Guangzhou
Zip:
510000
Country:
China
Status:
Recruiting
Investigator:
Last name:
Xueqing Yu
Email:
Principal Investigator
Start date:
June 14, 2024
Completion date:
July 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/NCT06434961
