Efficacy of Etelcalcetide vs Cinacalcet in Hemodialyzed Patients with Secondary Hyperparathyroidism
Not Applicable
- Conditions
- Secondary Hyperparathyroidism
- Registration Number
- JPRN-UMIN000034155
- Lead Sponsor
- Saitama Sekishinkai Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
Ineligible for the study as judged by the investigator
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The endpoints were the levels of corrected serum calcium, serum phosphorus, intact PTH, tartrate-resistant acid phosphatase (TRACP)-5b, and bone-type alkaline phosphatase (BAP). The mean corrected serum calcium, serum phosphorus, and intact PTH levels for 24 weeks before the start of treatment with etelcalcetide (pre-treatment values) were compared with those for 24 weeks after the start of treatment (post-treatment values). The mean TRACP-5b and BAP levels at the start of treatment (pre-treatment values) with etelcalcetide were also compared with those for 24 weeks after the start of treatment (post-treatment values). In addition, the endpoints were compared among treatment groups: cinacalcet hydrochloride-free group (n=8), low-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride <26 mg/day to etelcalcetide; n=29), and high-dose cinacalcet hydrochloride/etelcalcetide group (switched from cinacalcet hydrochloride > 26 mg/day to etelcalcetide; n=13).
- Secondary Outcome Measures
Name Time Method Whether or not the mean corrected serum calcium level significantly differed between the 19 subjects who underwent a washout period and the 23 subjects who did not, after the start of treatment with etelcalcetide.