A randomised study to assess the effects of Epoetin Beta on renal function in patients with critical illness(with or without multi-organ failure)

Status

Active, not recruiting

Phases

Phase 4

Study type

Interventional

Source

EU CTR

Registry ID

EUCTR2008-003733-24-GB

Enrollment

Registered

2008-10-03

Start date

2009-05-29

Completion date

Unknown

Last updated

2019-02-28

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Sepsis/Acute renal failure

Interventions

Trade Name: Neorecormon solution for injection (pre filled syringe) Product Name: Neo-recormon Product Code: EU/1/97/031/030 Pharmaceutical Form: Inject

Eligibility

Sex/Gender

All

Inclusion criteria

Inclusion criteria: Aged >18 years ITU stay > 12 hours – expected to stay for at least 3 days Hb less than 11.5 gm/dl Acute renal failure /and or requiring any form of inotrope support Defined as; Urine output 160mmol/L or doubling of baseline serum creatinine Are the trial subjects under 18? no Number of subjects for this age range: F.1.2 Adults (18-64 years) yes F.1.2.1 Number of subjects for this age range 15 F.1.3 Elderly (>=65 years) yes F.1.3.1 Number of subjects for this age range 15

Exclusion criteria

Exclusion criteria: Patients with haematological malignancies Haemolytic anaemia Haemorrhage (post operative/GI bleeding/multiple trauma) Hypertensive emergencies Known active solid tumour malignancy

Design outcomes

Primary

Measure	Time frame
Timepoint(s) of evaluation of this end point: This will be achieved by the cessation of the need for haemodialysis, increased urine output and improvement in serum creatinine levels;Main Objective: To assess the efficacy of Epo to decrease blood transfusion requirements in patients with critical illness;Secondary Objective: To assess the possible effect(s) of Epo on renal function in critically ill patients with and without multi-organ failure.; Primary end point(s): 1. Demonstrate shorter time to achieve normal renal function compared with placebo. 2. An attenuated renal injury as assessed by urinary markers to critical illness compared with placebo.	—

Measure

Time frame

Timepoint(s) of evaluation of this end point: This will be achieved by the cessation of the need for haemodialysis, increased urine output and improvement in serum creatinine levels;Main Objective: To assess the efficacy of Epo to decrease blood transfusion requirements in patients with critical illness;Secondary Objective: To assess the possible effect(s) of Epo on renal function in critically ill patients with and without multi-organ failure.; Primary end point(s): 1. Demonstrate shorter time to achieve normal renal function compared with placebo. 2. An attenuated renal injury as assessed by urinary markers to critical illness compared with placebo.

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Secondary

Measure	Time frame
Secondary end point(s): To assess the efficacy of Epo to decrease blood transfusion requirements in patients with critical illness.;Timepoint(s) of evaluation of this end point: This will be achieved by monitoring haemoglobin levels and routine consultant evaluation in respect to cardiovascular status.	—

Countries

United Kingdom

Contacts

Public ContactR&D Dept

Abertawe bro Morgannwyg

abm.rd@wales.nhs.uk01792704056

Outcome results

None listed

Source: EU CTR (via WHO ICTRP) · Data processed: Feb 4, 2026