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NCT05663411
A Study of SHR6508 in Secondary Hyperparathyroidism
Conditions: Secondary Hyperparathyroidism
Sex: All
Ages: 18 Years – N/A
Phase: PHASE2
Enrollment: 60
Sponsor: Shanghai Hengrui Pharmaceutical Co., Ltd.
Summary
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.
Eligibility Criteria
Inclusion Criteria:Able and willing to provide a written informed consentDiagnosed with end stage renal disease receiving stable hemodialysisMale or femaleMeet the Body Mass Index standardStably use of concomitant medication of other therapies of SHPTMeet the standard of iPTH level, cCa and HBExclusion Criteria:Subjects with a history of malignant tumorSubjects with neuropsychiatric diseasesSubjects with a history of cardiovascular diseasesSubjects with gastrointestinal diseasesSubjects with a history of surgerySubjects with a history of blood lossSubjects with a history of kidney transplantAbnormal blood pressure, serum magnesium, serum transaminase, serum albuminSubjects with a treatment history of similar drugsAllergic to a drug ingredient or componentPregnant or nursing womenNo birth control during the specified period of timeSubject with a history of alcohol abuse and drug abuseParticipated in clinical trials of other drugsThe investigators determined that other conditions were inappropriate for participation in this clinical trial
Source: ClinicalTrials.gov (NCT05663411). StuddyBuddy aggregates publicly available trial information.