The Trial of SHR6508 in Secondary Hyperparathyroidism

NCT06434961 | Completed Phase 3

• 1 other identifier: SHR6508-301
• Study Type: interventional
• Target: 498
• Locations: 1 country
• Sites: 1

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.

Conditions

Secondary Hyperparathyroidism

Outcome Measures

Primary Outcomes (1)

• 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 (6)

• Proportion of Participants to End of Study whose iPTH decreased by>50% from baseline

  efficacy assessment period, defined as Week 20-27

• Incidence of nausea and vomiting events

  Day1 to End of Treatment, End of Treatment is about Week 27

• Proportion of Participants to End of Treatment whose iPTH decreased to 300 pg/mL from baseline

  efficacy assessment period, defined as Week 20-27

• Change From Baseline in serum cCa and P

  efficacy assessment period, defined as Week 20-27

• Participants With Treatment-Emergent Adverse Events (TEAEs)

  Day1 to End of Study, End of Study is about Week 31

Study Arms (2)

Treatment group

EXPERIMENTAL

Drug: SHR6508 plus oral placebo tablets

Active Control group

ACTIVE COMPARATOR

Drug: Cinacalcet plus intravenous placebo

Interventions

Cinacalcet plus intravenous placebo DRUG

Cinacalcet plus intravenous placebo

Active Control group

SHR6508 plus oral placebo tablets DRUG

SHR6508 plus oral placebo tablets

Treatment group

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (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 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

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
• 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

Sponsors & Collaborators

• Shanghai Hengrui Pharmaceutical Co., Ltd.: lead

Study Sites (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, 510000, China

Location

MeSH Terms

Conditions

Hyperparathyroidism, Secondary

Interventions

Cinacalcet

Condition Hierarchy (Ancestors)

Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Naphthalenes; Polycyclic Aromatic Hydrocarbons; Hydrocarbons, Aromatic; Hydrocarbons, Cyclic; Hydrocarbons; Organic Chemicals; Polycyclic Compounds

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 24, 2024
• First Posted: May 30, 2024
• Study Start: June 14, 2024
• Primary Completion: September 29, 2025
• Study Completion: November 11, 2025
• Last Updated: December 12, 2025

Record last verified: 2025-12

Locations

CN (1)