UnknownPhase 2

A Study of SHR6508 in Secondary Hyperparathyroidism

China75 participantsStarted 2023-02-24

Plain-language 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.

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 stable 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 and HB

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
✕. Subjects with a history of kidney transplant
✕. Abnormal blood pressure, serum magnesium, serum transaminase, serum albumin

What they're measuring

Change From Baseline in serum iPTH

Timeframe: Baseline and the efficacy period, defined as Week 16

Trial details

NCT IDNCT05663411

SponsorShanghai Hengrui Pharmaceutical Co., Ltd.

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2023-10-31

View on ClinicalTrials.gov More Secondary Hyperparathyroidism trials