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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.


Clinical Trial 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 Design

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


Related Conditions & MeSH terms


NCT number NCT00676234
Study type Interventional
Source University Hospital, Geneva
Contact
Status Completed
Phase Phase 2
Start date May 2008
Completion date June 2009

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