A Study of SHR6508 in Secondary Hyperparathyroidism

Hengrui Medicine

Status and phase: Active, not recruiting; Phase 2

Conditions: Secondary Hyperparathyroidism

Treatments: Drug: Cinacalcet; Drug: SHR6508

Study type: Interventional

Funder types: Industry

Identifiers

NCT05663411

SHR6508-201

Details and patient eligibility

About

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.

Enrollment: 75 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 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

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75 participants in 3 patient groups

Treatment group A: SHR6508

Experimental group

Treatment:

Drug: SHR6508

Drug: SHR6508

Treatment group B: SHR6508

Experimental group

Treatment:

Drug: SHR6508

Drug: SHR6508

Treatment group C: Cinacalcet

Active Comparator group

Treatment:

Drug: Cinacalcet