Back to resultsA Study of SHR6508 in Secondary Hyperparathyroidism
Primary Purpose
Secondary Hyperparathyroidism
Status
Active
Phase
Phase 2
Locations
China
Study Type
Interventional
Intervention
SHR6508
SHR6508
Cinacalcet
Sponsored by
About this trial
This is an interventional treatment trial for Secondary Hyperparathyroidism
Eligibility Criteria
Inclusion Criteria: 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 Stably use of concomitant medication of other therapies of SHPT Meet the standard of iPTH level, cCa and HB Exclusion Criteria: 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 kidney transplant Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 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 The investigators determined that other conditions were inappropriate for participation in this clinical trial
Sites / Locations
- Guangdong Provincial People's Hospital
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Experimental
Experimental
Active Comparator
Arm Label
Treatment group A: SHR6508
Treatment group B: SHR6508
Treatment group C: Cinacalcet
Arm Description
Outcomes
Primary Outcome Measures
Change From Baseline in serum iPTH
iPTH was tested at a central laboratory.
Secondary Outcome Measures
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
iPTH was tested at a central laboratory.
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
iPTH was tested at a central laboratory.
Change From Baseline in serum cCa and P
cCa and P were tested at a local laboratory.
Participants With Treatment-Emergent Adverse Events (TEAEs)
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Full Information
NCT ID
NCT05663411
First Posted
December 14, 2022
Last Updated
June 16, 2023
Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
1. Study Identification
Unique Protocol Identification Number
NCT05663411
Brief Title
A Study of SHR6508 in Secondary Hyperparathyroidism
Official Title
An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism
Study Type
Interventional
2. Study Status
Record Verification Date
November 2022
Overall Recruitment Status
Active, not recruiting
Study Start Date
February 24, 2023 (Actual)
Primary Completion Date
October 31, 2023 (Anticipated)
Study Completion Date
November 30, 2023 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Shanghai Hengrui Pharmaceutical Co., Ltd.
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
5. Study Description
Brief Summary
The study is being conducted to evaluate the efficacy and safety of SHR6508 for Chinese patients with secondary hyperparathyroidism of chronic kidney disease treated by maintenance hemodialysis.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Secondary Hyperparathyroidism
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
75 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Treatment group A: SHR6508
Arm Type
Experimental
Arm Title
Treatment group B: SHR6508
Arm Type
Experimental
Arm Title
Treatment group C: Cinacalcet
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
SHR6508
Intervention Description
SHR6508
Intervention Type
Drug
Intervention Name(s)
SHR6508
Intervention Description
SHR6508
Intervention Type
Drug
Intervention Name(s)
Cinacalcet
Intervention Description
Cinacalcet
Primary Outcome Measure Information:
Title
Change From Baseline in serum iPTH
Description
iPTH was tested at a central laboratory.
Time Frame
Baseline and the efficacy period, defined as Week 16
Secondary Outcome Measure Information:
Title
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline
Description
iPTH was tested at a central laboratory.
Time Frame
Baseline and the efficacy period, defined as Week 16
Title
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline
Description
iPTH was tested at a central laboratory.
Time Frame
Baseline and the efficacy period, defined as Week 16
Title
Change From Baseline in serum cCa and P
Description
cCa and P were tested at a local laboratory.
Time Frame
Baseline and the efficacy period, defined as Week 16
Title
Participants With Treatment-Emergent Adverse Events (TEAEs)
Description
Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Time Frame
Day1 to End of Study, End of Study is about Week 20
Title
Participants with Anti-SHR6508 Antibody at baseline and postbaseline
Time Frame
Day1 to End of Study, End of Study is about Week 20
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Stably use of concomitant medication of other therapies of SHPT
Meet the standard of iPTH level, cCa and HB
Exclusion Criteria:
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 kidney transplant
Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
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
The investigators determined that other conditions were inappropriate for participation in this clinical trial
Facility Information:
Facility Name
Guangdong Provincial People's Hospital
City
Guangzhou
State/Province
Guangdong
ZIP/Postal Code
510000
Country
China
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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A Study of SHR6508 in Secondary Hyperparathyroidism
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