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

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ClinicalTrials.gov Identifier: NCT00676234
Recruitment Status : Completed
First Posted : May 12, 2008
Last Update Posted : June 30, 2009
Sponsor:
Information provided by:
University Hospital, Geneva

Brief 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.

Condition or disease Intervention/treatment Phase
Acute Renal Failure Drug: epoetinum Phase 2

Detailed 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).


Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 80 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
Study Start Date : May 2008
Actual Primary Completion Date : June 2009
Actual Study Completion Date : June 2009

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
No Intervention: 1
Experimental: 2
Administration of intravenous rhu Epo on Day 0
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
Other Name: Eprex



Primary Outcome Measures :
  1. mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection [ Time Frame: 4 days ]

Secondary Outcome Measures :
  1. mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection [ Time Frame: 4 days ]


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Ages Eligible for Study:   18 Years and older   (Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00676234


Locations
Switzerland
Nephrology Unit, Geneva University Hospitals
Geneva, Switzerland, 1211
Sponsors and Collaborators
University Hospital, Geneva
Investigators
Principal Investigator: Patrick Saudan, Dr Nephrology Unit Geneva University Hospitals

Publications automatically indexed to this study by ClinicalTrials.gov Identifier (NCT Number):
Responsible Party: Dr P. Saudan, Nephrology Unit
ClinicalTrials.gov Identifier: NCT00676234     History of Changes
Other Study ID Numbers: 2008-11021991
First Posted: May 12, 2008    Key Record Dates
Last Update Posted: June 30, 2009
Last Verified: June 2009

Keywords provided by University Hospital, Geneva:
erythropoietin

Additional relevant MeSH terms:
Renal Insufficiency
Acute Kidney Injury
Kidney Diseases
Urologic Diseases
Epoetin Alfa
Hematinics