ONO-5163 Phase III long-term study (ONO-5163-04)
Phase 3
Completed
- Conditions
- Secondary hyperparathyroidism
- Registration Number
- JPRN-jRCT2080222614
- Lead Sponsor
- ONO PHARMACEUTICAL CO.,LTD.
- Brief Summary
ONO-5163 was well tolerated when used for long-term (52w) in HD pts with SHPT. AE incidence did not increase with a prolonged term. Unlike existing CaSR agonists, no clinically considerable gastrointestinal AE was noted. No effect was reduced. Thus, the long-term ONO-5163 at the study dosage (at first 5 mg and individual adjustment ranged from 2.5 to 15 mg per titration criteria to sustain serum iPTH of 60-240 pg/mL) and admin. (via a venous blood line after HD) was found safe, tolerated, and effective.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- completed
- Sex
- All
- Target Recruitment
- 191
Inclusion Criteria
1. Chronic renal failure patient with a complica-tion of SHPT
2. Patients with a history of hemodialysis 3 times per week for 90 days or more prior to the start of screening period
Exclusion Criteria
1. Patient with primary hyperparathyroidism
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method safety<br>Safety
- Secondary Outcome Measures
Name Time Method efficacy<br>Efficacy