A Study of SHR6508 in Secondary Hyperparathyroidism

Shanghai Hengrui Pharmaceutical Co., Ltd.75 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

NONE

Enrollment

Conditions

Secondary Hyperparathyroidism

Interventions

SHR6508DRUG

SHR6508

SHR6508DRUG

SHR6508

CinacalcetDRUG

Cinacalcet

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 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

Locations (1)

Guangdong Provincial People's Hospital

Guangzhou, Guangdong, China

Outcomes

Primary Outcomes

Change From Baseline in serum iPTH

iPTH was tested at a central laboratory.

Time frame: Baseline and the efficacy period, defined as Week 16

Secondary Outcomes

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

iPTH was tested at a central laboratory.

Time frame: 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

iPTH was tested at a central laboratory.

Time frame: Baseline and the efficacy period, defined as Week 16

Change From Baseline in serum cCa and P

cCa and P were tested at a local laboratory.

Time frame: Baseline and the efficacy period, defined as Week 16

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 20

Participants with Anti-SHR6508 Antibody at baseline and postbaseline

Time frame: Day1 to End of Study, End of Study is about Week 20

Data from ClinicalTrials.gov

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