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NCT03305471 · ClinicalTrials.gov registry record · Phase 1

DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis

A Phase 1 study, sponsored by Daiichi Sankyo.

Completed
Registry status
Phase 1
Development phase
40
Enrollment target

NCT03305471: Completed Phase 1 study, sponsored by Daiichi Sankyo.

NCT03305471 is a Phase 1 study that has completed, run by Daiichi Sankyo. The registered enrollment target is 40 participants, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower). According to ClinicalTrials.gov, the official US trial registry.

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The verdict

NCT03305471, a Phase 1 study, has completed, sponsored by Daiichi Sankyo.

COMPLETED
Registry status
Phase 1
Development phase
40 participants
Enrollment target

Study 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 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.

Interventions

  • DRUG Placebo
  • DRUG Sevelamer
  • DRUG DS-2330b PIB
  • DRUG DS-2330b Tablet

Trial Details

FieldValue
Enrollment Target 40 participants
Start Date 2017-08-17
Est. Completion 2019-01-03
Phase Phase 1
Daiichi Sankyo

236 total trials

What the finished NCT03305471 record still lists

NCT03305471 is an interventional study that assigns participants to a tested intervention. The registry caps enrollment at 40 participants, a relatively small participant target, below the 60-participant average among 29,502 other Phase 1 trials with a reported enrollment target (33% lower).

The record links to 0 conditions, and to 4 interventions - of which Placebo is the first listed.

NCT03305471 does not publish any study locations in the registry export this page uses.

Frequently Asked Questions

What is clinical trial NCT03305471 about?

NCT03305471 is a clinical study titled "DS2330b Alone and With Sevelamer in Patients on Chronic Hemodialysis". 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 ...

What is the current status of trial NCT03305471?

This trial is currently completed. It is a Phase 1 study. The enrollment target is 40 participants. The study started on 2017-08-17. Estimated completion is 2019-01-03.

What interventions are being tested in trial NCT03305471?

The interventions under investigation include: Placebo (DRUG), Sevelamer (DRUG), DS-2330b PIB (DRUG), DS-2330b Tablet (DRUG).

Who is sponsoring clinical trial NCT03305471?

This trial is sponsored by Daiichi Sankyo, which has 236 total clinical trials registered on ClinicalTrials.gov.

How this trial's enrollment target compares

Where NCT03305471's enrollment target sits among peer trials

40 1130th of 2000 higher than 810 of 2,000 other Phase 1 trials

participants (enrollment target), bucketed by value

Each bar is a band; taller bars hold more other Phase 1 trials. The dashed line + filled bar mark this entry. Hover or tap any bar for its full count and share, and where it sits relative to this entry.

Source ClinicalTrials.gov registry export · 2026-08-08

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Source: ClinicalTrials.gov NCT03305471, the US trial registry maintained by the National Library of Medicine. NCT03305471 (small enrollment · none site footprint · completed) retrieved and formatted by PlainTrial, see methodology.