At a glance
ClinicalIndex Comparison RecordPhase 2Completed· 12 enrolled
Drug / intervention
Soluble Ferric Pyrophosphate +1 moredrug
Likely dose
Not stated in 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 Controlled, Randomized Study to Assess the Quantitative Mass Transfer of Iron From SFP-containing Hemodialysate Under Varying Conditions of Blood and Dialysate Flow Rates, Dialyzer Membrane Types and Dialysate Bicarbonate Concentrations in CKD-HD Patients.
In Brief
A Phase 2 clinical trial evaluating Soluble Ferric Pyrophosphate and Placebo for Kidney Failure. Completed, enrolled 12 participants across 1 site.
Detailed Summary
The purpose of this study is to determine the quantity of iron derived from SFP that is transferred from the dialysate to patients during a single dialysis session. The effects of various conditions which may affect the transfer of iron such as blood and dialysate flow rate, changes in bicarbonate delivery, dialyzer membrane type and the effect of reuse will also be investigated. The absorption and removal of iron from the blood will also be investigated.
Study Details
Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
ConditionsKidney Failure
CountriesUnited States
Collaborators--
Timeline
Phase 2CompletedFinished
2014201520162017201820192020202120222023202420252026
Enrollment StartJul 2013
First PostedJul 2013
Primary CompletionSep 2013
TodayJul 2026
First PostedJul 10, 2013
Enrollment StartJul 1, 2013
Primary CompletionSep 1, 2013
TodayJul 2, 2026
Enrollment to primary: 2 monthsPosted 13.0 years ago
Interventions
Soluble Ferric Pyrophosphatedrug
Placeboother