Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure

Acute Renal Failure Clinical Trial

Official title:

Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00676234
• Other study ID #: 2008-11021991
• Status: Completed
• Phase: Phase 2
• First received: May 7, 2008
• Last updated: June 26, 2009
• Start date: May 2008
• Est. completion date: June 2009

Study information

• Verified date: June 2009
• Source: University Hospital, Geneva
• Contact: n/a
• Is FDA regulated: No
• Health authority: Switzerland: Swissmedic
• Study type: Interventional

Clinical Trial Summary

Pilot study aiming to assess the effect of two doses of rhu EPO on urine NGAL concentration and on serum cystatin C and creatinine levels in critically ill patients at risk of ARF.

Description:

Research plan Open-label randomized trial Twelve months duration trial Setting: Medical and Surgical Intensive Care Unit of the University Hospitals of Geneva Start of trial: Mid-May 2008

Patients randomly allocated to 2 treatment groups (20 patients per group), or a control group (40 patients):

• Group 1: control group (40 patients)

• Group 2 : 20000 IU rhu Epo (20 patients) administered by the i.v. route

• Group 3 : 40000 IU rhu Epo (20 patients) administered by the i.v. route

3.2. Trial design Day 0 Consent form signed Patients randomly allocated to control or treatment groups (20000 and 40000 IU) Serum Cystatin C determination Serum Creatinine determination Urinary NGAL determination Administration of intravenous rhu Epo on Day 0 or no Epo (control group) Day 2 At 48 hr after rhu EPO injection, samples will be taken for

• Serum Cystatin C determination

• Serum Creatinine determination

• Urinary NGAL determination Day 4 At 96 hr after rhu EPO injection, samples will be taken for

• Serum Cystatin C determination

• Serum Creatinine determination

• Urinary NGAL determination

Stopping rules

The trial for an individual subject, parts of the trial or the entire trial will be stopped when:

• at Day 4 for an individual subject

• after enrollment of 80 patients

Treatment The treatment will consist of intravenous (i.v.) injections of recombinant human erythropoietin (r-hu-EPO). The trial medication will be provided by JANSSEN-CILAG AG. The brand name is EPREX® which is epoietinum-alpha in sterile buffered solution for i.v. or s.c. injection.

Patient group 1 will not receive EPO treatment. Patient group 2 will receive 20'000 U of rhu EPO and patient group 3 will receive 40'000 U of rhu EPO (i.v. route).

Recruitment information / eligibility

• Status: Completed
• Enrollment: 80
• Est. completion date: June 2009
• Est. primary completion date: June 2009
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years and older

Eligibility

Inclusion Criteria:

• Patients at risks for acute tubular necrosis (patients with mechanical ventilation, patients with sepsis, in the post-operative state, with hemodynamic impairment or with previous chronic renal failure.

• Consent form signed

Exclusion Criteria:

• Patients with malignant hypertension

• Patients with systolic BP > 150 mmHg at enrollment

• Patients with Hb level > 120g/L

• Patients with acute coronaropathy

• Pregnancy

• Patients with urine output < 600 ml/12 h

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Acute Kidney Injury
• Acute Renal Failure
• Renal Insufficiency

Intervention

Drug:
• epoetinum
Administration of intravenous rhu Epo on Day 0 20000 IU rhu Epo (20 patients) administered by the i.v. route 40000 IU rhu Epo (20 patients) administered by the i.v. route

Locations

Country	Name	City	State
Switzerland	Nephrology Unit, Geneva University Hospitals	Geneva

Sponsors (1)

Lead Sponsor	Collaborator
University Hospital, Geneva

Country where clinical trial is conducted

Switzerland, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection		4 days	No
Secondary	mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection		4 days	No