NCT05663411

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
75

participants targeted

Target at P50-P75 for phase_2

Timeline
Completed

Started Feb 2023

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

December 14, 2022

Completed
9 days until next milestone

First Posted

Study publicly available on registry

December 23, 2022

Completed
2 months until next milestone

Study Start

First participant enrolled

February 24, 2023

Completed
8 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 31, 2023

Completed
1 month until next milestone

Study Completion

Last participant's last visit for all outcomes

November 30, 2023

Completed
Last Updated

June 18, 2023

Status Verified

November 1, 2022

Enrollment Period

8 months

First QC Date

December 14, 2022

Last Update Submit

June 16, 2023

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

  • Change From Baseline in serum iPTH

    iPTH was tested at a central laboratory.

    Baseline and the efficacy period, defined as Week 16

Secondary Outcomes (5)

  • Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline

    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

    Baseline and the efficacy period, defined as Week 16

  • Change From Baseline in serum cCa and P

    Baseline and the efficacy period, defined as Week 16

  • Participants With Treatment-Emergent Adverse Events (TEAEs)

    Day1 to End of Study, End of Study is about Week 20

  • Participants with Anti-SHR6508 Antibody at baseline and postbaseline

    Day1 to End of Study, End of Study is about Week 20

Study Arms (3)

Treatment group A: SHR6508

EXPERIMENTAL
Drug: SHR6508

Treatment group B: SHR6508

EXPERIMENTAL
Drug: SHR6508

Treatment group C: Cinacalcet

ACTIVE COMPARATOR
Drug: Cinacalcet

Interventions

SHR6508DRUG

SHR6508

Treatment group A: SHR6508
CinacalcetDRUG

Cinacalcet

Treatment group C: Cinacalcet

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

HyperparathyroidismParathyroid DiseasesEndocrine System Diseases

Intervention Hierarchy (Ancestors)

NaphthalenesPolycyclic Aromatic HydrocarbonsHydrocarbons, AromaticHydrocarbons, CyclicHydrocarbonsOrganic ChemicalsPolycyclic Compounds

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2022

First Posted

December 23, 2022

Study Start

February 24, 2023

Primary Completion

October 31, 2023

Study Completion

November 30, 2023

Last Updated

June 18, 2023

Record last verified: 2022-11

Locations

CN(1)