At a glance
ClinicalIndex Comparison RecordPhase 1Completed· 24 enrolled
Drug / intervention
Oseltamivirdrug
Likely dose
Oseltamivir 30 mgfrom record
Structured eligibility isn't available for this trial yet — see the full criteria in the Eligibility tab below.
Standardized by ClinicalIndex from the ClinicalTrials.gov record · verify against the source.
A Single Center, Open Label, Multiple-Dose Oral Oseltamivir Suspension Study in End-Stage-Renal Disease (ESRD) Patients on Hemodialysis (HD) and Continuous Ambulatory Peritoneal Dialysis (CAPD)
In Brief
A Phase 1 clinical trial evaluating Oseltamivir for End Stage Renal Disease. Completed, enrolled 24 participants across 1 site.
Detailed Summary
This study is designed to assess the pharmacokinetics (PK) and safety of oseltamivir and its metabolite oseltamivir carboxylate in participants undergoing routine HD and CAPD for end-stage renal disease (ESRD). Participants will receive 6.5 and 6 weeks of the marketed oral oseltamivir suspension dosed according to the HD or CAPD schedule, respectively.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsEnd Stage Renal Disease
CountriesNew Zealand
Collaborators--
Timeline
Phase 1CompletedFinished
20022003200420052006200720082009201020112012201320142015201620172018201920202021202220232024202520262027
Enrollment StartOct 2001
Primary CompletionJun 2002
First PostedDec 2015
TodayJul 2026
First PostedDec 1, 2015
Enrollment StartOct 1, 2001
Primary CompletionJun 1, 2002
TodayJul 2, 2026
Enrollment to primary: 8 monthsPosted 10.6 years ago
Interventions
Oseltamivirdrug
Oseltamivir will be given as marketed oral suspension, 30 mg after HD or CAPD treatment.