A Study of SHR6508 in Secondary Hyperparathyroidism | NCT05663411

Studies
A Study of SHR6508 in Secondary Hyperparathyroidism

NCT05663411

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Status

Unknown status

Last Update Posted

Jun 18, 2023Actual

Enrollment

75Actual

Phase

Phase 2

Conditions

Secondary Hyperparathyroidism

Interventions

SHR6508
SHR6508
Cinacalcet

Countries

China

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Nov 2022

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Active, not recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Feb 24, 2023Actual

Primary Completion Date

Oct 31, 2023Estimated

Completion Date

Nov 30, 2023Estimated

First Submitted Date

Dec 14, 2022

First Submission Date that Met QC Criteria

Dec 21, 2022

First Posted Date

Dec 23, 2022Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Jun 16, 2023

Last Update Posted Date

Jun 18, 2023Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Not provided

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

75Actual

Arms/Interventions Module

Arm Groups

Label	Type	Intervention Names
Treatment group A: SHR6508	Experimental	Drug: SHR6508
Treatment group B: SHR6508	Experimental	Drug: SHR6508
Treatment group C: Cinacalcet	Active Comparator	Drug: Cinacalcet

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR6508	Drug	SHR6508	Treatment group A: SHR6508
SHR6508

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Change From Baseline in serum iPTH	iPTH was tested at a central laboratory.	Baseline and the efficacy period, defined as Week 16

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline	iPTH was tested at a central laboratory.	Baseline and the efficacy period, defined as Week 16
Proportion of Participants to End of Study whose iPTH decreased to 300 pg/mL from baseline

Other Outcomes

Not provided

Eligibility Module

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

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

18 Years

Maximum Age

Not provided

Standard Ages

AdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Facility	Status	City	State	ZIP	Country	Contacts
Guangdong Provincial People's Hospital		Guangzhou	Guangdong	510000	China

IPD Sharing Statement Module

Plan to Share IPD

Undecided

Description

Not provided

Types

Not provided

Time Frame

Not provided

Access Criteria

Not provided

URL

Not provided

Condition Browse Module

MeSH Terms

ID	Term
D006962	Hyperparathyroidism, Secondary

Ancestor Terms

ID	Term
D006961	Hyperparathyroidism
D010279	Parathyroid Diseases
D004700	Endocrine System Diseases

Browse Leaves

Not provided

Browse Branches

Not provided

Intervention Browse Module

MeSH Terms

ID	Term
D000069449	Cinacalcet

Ancestor Terms

ID	Term
D009281	Naphthalenes
D011084	Polycyclic Aromatic Hydrocarbons
D006841	Hydrocarbons, Aromatic
D006844	Hydrocarbons, Cyclic

Browse Leaves

Not provided

Browse Branches

Not provided