DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis
Completed · Phase 1 · Has a placebo group
Conditions studied: Hyperphosphatemia
In brief
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 bottle (PIB) or tablet formulations of DS2330b * Part B will test the safety, tolerability, and effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b PIB when given alone and when given along with sevelamer carbonate three times a day * Part C is optional, and will test the effects on serum phosphate (Pi) of 14-day repeated oral doses of DS-2330b tablets when given with sevelamer carbonate After screening, participants should expect the study to last about 21 days for Part A, and 46 days for Parts B and C.
Key facts
- Study ID
- NCT03305471
- Run by
- Daiichi Sankyo
- People needed
- 40
- Starts
- 2017-08-17
- Expected to finish
- 2019-01-03
- Last updated by the study team
- 2019-03-25
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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
Where it is running
- DaVita Clinical Research — Lakewood, Colorado, United States
- Orlando Clinical Research Center — Orlando, Florida, United States
- DaVita Clinical Research — Minneapolis, Minnesota, United States
- Prism Clinical Research — Saint Paul, Minnesota, United States
Full record on ClinicalTrials.gov
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