CompletedPhase 3

The Trial of SHR6508 in Secondary Hyperparathyroidism

China498 participantsStarted 2024-06-14

Plain-language summary

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.

Who can participate

Age range18 Years

SexALL

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Inclusion criteria

✓. Able and willing to provide a written informed consent
✓. Diagnosed with end stage renal disease receiving maintenance hemodialysis
✓. Male or female
✓. Meet the Body Mass Index standard
✓. Stably use of concomitant medication of other therapies of SHPT
✓. Meet the standard of iPTH level, cCa

Exclusion criteria

✕. Subjects with a history of malignant tumor
✕. Subjects with neuropsychiatric diseases
✕. Subjects with a history of cardiovascular diseases
✕. Subjects with gastrointestinal diseases
✕. Subjects with a history of surgery
✕. Subjects with a history of blood loss
✕. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin
✕. Subjects with a treatment history of similar drugs

What they're measuring

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

Timeframe: efficacy assessment period, defined as Week 20-27

Trial details

NCT IDNCT06434961

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2025-09-29

View on ClinicalTrials.gov More Secondary Hyperparathyroidism trials