The Trial of SHR6508 in Secondary Hyperparathyroidism | NCT06434961

Studies
The Trial of SHR6508 in Secondary Hyperparathyroidism

NCT06434961

Sponsor

Shanghai Hengrui Pharmaceutical Co., Ltd.

Status

Completed

Last Update Posted

Dec 12, 2025Actual

Enrollment

498Actual

Phase

Phase 3

Conditions

Secondary Hyperparathyroidism

Interventions

SHR6508 plus oral placebo tablets
Cinacalcet plus intravenous placebo

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

Dec 2025

Overall Recruitment Status or Expanded Access Status

Completed

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 14, 2024Actual

Primary Completion Date

Sep 29, 2025Actual

Completion Date

Nov 11, 2025Actual

First Submitted Date

May 24, 2024

First Submission Date that Met QC Criteria

May 24, 2024

First Posted Date

May 30, 2024Actual

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

Dec 11, 2025

Last Update Posted Date

Dec 12, 2025Actual

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 among 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 3

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

498Actual

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
Treatment group	Experimental		Drug: SHR6508 plus oral placebo tablets
Active Control group	Active Comparator		Drug: Cinacalcet plus intravenous placebo

Interventions

Name	Type	Description	Arm Group Labels	Other Names
SHR6508 plus oral placebo tablets	Drug	SHR6508 plus oral placebo tablets	Treatment group

Outcomes Module

Primary 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.	efficacy assessment period, defined as Week 20-27

Secondary Outcomes

Measure	Description	Time Frame
Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline	iPTH was tested at a central laboratory.	efficacy assessment period, defined as Week 20-27
Incidence of nausea and vomiting events

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 maintenance 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

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
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