CI

At a glance

ClinicalIndex Comparison Record
Phase 4Completed· 197 enrolled
Drug / intervention
Iron sucrose +1 moredrug
Likely dose
Iron sucrose 200mgfrom 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.

Search/NCT02707757
NCT02707757Phase 4Completed

Predictors of Response to Treatment With Iron and Erythropoietin in Dialysis Anaemia

Imperial College Healthcare NHS Trust·interventional·Posted Mar 14, 2016·Updated Apr 14, 2021

In Brief

A Phase 4 clinical trial evaluating Iron sucrose and Erythopoietin stimulating agent for Anaemia and Haemodialysis. Completed, enrolled 197 participants across 2 sites.

Detailed Summary

Anaemia in dialysis patients requires treatment with frequent dose adjustments. There are two current possible treatments for anaemia which are iron and erythropoietin stimulating agents (ESA). Dosages of these medications are currently guided by a patient's ferritin levels and haemoglobin, but these markers are known to be inaccurate. The current clinical protocol therefore tends towards overuse of both agents which can be associated with toxicity, and the reliance on these markers prevents retrospective assessment of treatment responsiveness. This study is designed to investigate the factors which predict which agent would produce a better response. Patients with a fall in haemoglobin will be given treatment with either iron or an increased dose of ESA as they are currently, but allocated at random rather than by poorly performing biochemical markers. The iron treated and ESA treated groups can then be analysed for factors which predict response in o

Study Details

Study Typeinterventional
Allocation--
Masking--
Primary Purpose--
CountriesUnited Kingdom
Collaborators--

Timeline

Phase 4CompletedFinished
20162017201820192020202120222023202420252026
First PostedMar 14, 2016
Enrollment StartJul 1, 2015
Primary CompletionDec 1, 2016
Study CompletionApr 1, 2017
TodayJul 2, 2026
Enrollment to primary: 1.4 yearsPosted 10.3 years ago

Interventions

Iron sucrosedrug

1gram of iron sucrose (5 200mg aliquots) administered if participant's haemoglobin is less than 9.5g/dl

Erythopoietin stimulating agentdrug

Incremental increase in dose of erythropoeitin stimulating agent being administered as per a pre-defined criteria