Ignite Creation Date:
2025-12-25 @ 2:23 AM
Ignite Modification Date:
2026-01-24 @ 9:58 PM
Study NCT ID:
NCT00676234
Status:
COMPLETED
Last Update Posted:
2009-06-30
First Post:
2008-05-07
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
Sponsor:
University Hospital, Geneva
Organization:
Study Overview
Official Title:
Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
Status:
COMPLETED
Status Verified Date:
2009-06
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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.
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).
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 Oversight
Has Oversight DMC:
False
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?: