The Trial of SHR6508 in Secondary Hyperparathyroidism

Hengrui Medicine

Status and phase: Completed; Phase 3

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Cinacalcet plus intravenous placebo; Drug: SHR6508 plus oral placebo tablets

Study type: Interventional

Funder types: Industry

Identifiers

NCT06434961

SHR6508-301

Details and patient eligibility

About

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.

Enrollment: 498 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Quadruple Blind

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498 participants in 2 patient groups

Treatment group

Experimental group

Treatment:

Drug: SHR6508 plus oral placebo tablets

Active Control group

Active Comparator group

Treatment:

Drug: Cinacalcet plus intravenous placebo