Status:
COMPLETED
DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
Lead Sponsor:
Daiichi Sankyo
Conditions:
Hyperphosphatemia
Eligibility:
All Genders
18-80 years
Phase:
PHASE1
Brief Summary
This three-part study will be performed with participants on chronic hemodialysis. * Part A will assess plasma pharmacokinetics of DS2330a (free form of DS2330b) after a single dose of powder in bott...
Eligibility Criteria
Inclusion
- Has a body mass index (BMI) of 18 kg/m\^2 to 40 kg/m\^2 (inclusive)
- Is on prescribed maintenance hemodialysis (three times a week) for at least 3 months before Screening with adequacy demonstrated by a dialysis clearance within 3 months before the first dose of the investigational medicinal product
- Has permanent vascular access \[arteriovenous (A-V) fistula or graft\]
- Is willing to comply with protocol-specified methods for family planning
- For Parts B and C only:
- Has protocol-specified acceptable serum Pi levels at Screening and in serum Pi after up to 3 weeks of washout from all Pi binders
- Has protocol-specified acceptable serum Ca\^2+ level and intact parathyroid hormone (iPTH) level at screening
Exclusion
- Is employed by the clinic or the sponsor
- Has family relationship with another study participant
- Has any history, current condition, or drug use that per protocol or in the opinion of the investigator might compromise:
- safety of the participant or their children
- safety of study staff
- analysis of study results
- For Parts B and C only:
- Is not able to take sevelamer carbonate
- Has had partial or total parathyroidectomy within the last six months
Key Trial Info
Start Date :
August 17 2017
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
January 3 2019
Estimated Enrollment :
40 Patients enrolled
Trial Details
Trial ID
NCT03305471
Start Date
August 17 2017
End Date
January 3 2019
Last Update
March 25 2019
Active Locations (4)
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1
DaVita Clinical Research
Lakewood, Colorado, United States, 80228
2
Orlando Clinical Research Center
Orlando, Florida, United States, 32809
3
DaVita Clinical Research
Minneapolis, Minnesota, United States, 55404
4
Prism Clinical Research
Saint Paul, Minnesota, United States, 55114