A Study of SHR6508 in Secondary Hyperparathyroidism

An Open-label, Randomized, Active-Controlled Dose Titration Study to Assess the Efficacy and Safety of SHR6508 in Hemodialysis Subjects With Secondary Hyperparathyroidism

Status

UNKNOWN

Phases

Phase 2

Study type

Interventional

Source

ClinicalTrials.gov

Registry ID

NCT05663411

Enrollment

Registered

2022-12-23

Start date

2023-02-24

Completion date

2023-11-30

Last updated

2023-06-18

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Secondary Hyperparathyroidism

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.

Interventions

DRUGSHR6508

SHR6508

DRUGCinacalcet

Cinacalcet

Study design

Allocation

RANDOMIZED

Intervention model

PARALLEL

Primary purpose

TREATMENT

Masking

NONE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

Inclusion criteria

1. Able and willing to provide a written informed consent 2. Diagnosed with end stage renal disease receiving stable 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 and HB

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. Subjects with a history of kidney transplant 8. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 9. Subjects with a treatment history of similar drugs 10. Allergic to a drug ingredient or component 11. Pregnant or nursing women 12. No birth control during the specified period of time 13. Subject with a history of alcohol abuse and drug abuse 14. Participated in clinical trials of other drugs 15. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Design outcomes

Primary

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

Secondary

Measure	Time frame	Description
Proportion of Participants to End of Study whose iPTH decreased by≥30% from baseline	Baseline and the efficacy period, defined as Week 16	iPTH was tested at a central laboratory.
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	iPTH was tested at a central laboratory.
Change From Baseline in serum cCa and P	Baseline and the efficacy period, defined as Week 16	cCa and P were tested at a local laboratory.
Participants With Treatment-Emergent Adverse Events (TEAEs)	Day1 to End of Study, End of Study is about Week 20	Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)
Participants with Anti-SHR6508 Antibody at baseline and postbaseline	Day1 to End of Study, End of Study is about Week 20	—

Countries

China

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026