The Trial of SHR6508 in Secondary Hyperparathyroidism

Shanghai Hengrui Pharmaceutical Co., Ltd.498 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

QUADRUPLE

Enrollment

498

Conditions

Secondary Hyperparathyroidism

Interventions

SHR6508 plus oral placebo tabletsDRUG

SHR6508 plus oral placebo tablets

Cinacalcet plus intravenous placeboDRUG

Cinacalcet plus intravenous placebo

Eligibility

Sex: ALLMin age: 18 Years

Medical Language ↔ Plain English

Inclusion Criteria: 1. Able and willing to provide a written informed consent 2. Diagnosed with end stage renal disease receiving maintenance 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 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. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin 8. Subjects with a treatment history of similar drugs 9. Allergic to a drug ingredient or component 10. Pregnant or nursing women 11. No birth control during the specified period of time 12. Subject with a history of alcohol abuse and drug abuse 13. Participated in clinical trials of other drugs 14. The investigators determined that other conditions were inappropriate for participation in this clinical trial

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

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

iPTH was tested at a central laboratory.

Time frame: efficacy assessment period, defined as Week 20-27

Secondary Outcomes

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

iPTH was tested at a central laboratory.

Time frame: efficacy assessment period, defined as Week 20-27

Incidence of nausea and vomiting events

Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

Time frame: 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

iPTH was tested at a central laboratory.

Time frame: efficacy assessment period, defined as Week 20-27

Change From Baseline in serum cCa and P

cCa and P were tested at a central laboratory.

Time frame: efficacy assessment period, defined as Week 20-27

Participants With Treatment-Emergent Adverse Events (TEAEs)

Terms were coded with Medical Dictionary for Regulatory Activities (MedDRA)

Time frame: Day1 to End of Study, End of Study is about Week 31

Participants with Anti-SHR6508 Antibody at baseline and postbaseline

Anti-SHR6508 Antibody was measured in patient serum samples using a validated enzyme-linked immunosorbent assay (ELISA) method.

Data from ClinicalTrials.gov

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