Acute Renal FailurePhase 2NCT00676234
Recombinant Human Erythropoietin Use in Intensive Care Unit (ICU) Patients: Does it Prevent Acute Renal Failure
A Phase 2 study testing epoetinum in people with Acute Renal Failure, run by University Hospital, Geneva at 1 site in Switzerland.
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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Renal Failure
- What is being tested?
- epoetinum
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 80 participants
- Where
- 1 siteSwitzerland
- Study dates
- May 2008to Jun 2009
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
Switzerland1 site
Nephrology Unit, Geneva University Hospitals
Geneva, Canton of Geneva, 1211
About this study
Official title: Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
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.
Read the 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).
- Conditions
- Acute Renal Failure
- Being tested
- epoetinum
- Keywords
- erythropoietin
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
epoetinumDrug
Also called Eprex
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
| Study group | Role | What they receive |
|---|---|---|
| 1 | No intervention | Not described |
| 2 | Experimental | Administration of intravenous rhu Epo on Day 0 Receives: Drug: epoetinum |
What is being measured
The primary outcome is the main question the study is designed to answer.
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
Measured: 4 days
Secondary outcomes (1)
mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection
Measured: 4 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 May 2008 (estimated)
- Study startMay 2008
- Primary completionJun 2009
- Study completionJun 2009
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Acute Renal FailureStudies of the same condition, open and under way.
- More trials run by University Hospital, GenevaThe sponsor's other registered studies.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- University Hospital, Geneva
- Sponsor type
- University, hospital or other
- Investigators
- Patrick Saudan, Dr, Principal investigator, Nephrology Unit Geneva University Hospitals
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00676234
- Sponsor's protocol ID
- 2008-11021991
- Other IDs
- 2008
- Status last verified
- Jun 2009
- First submitted
- 7 May 2008
- Last updated
- 30 Jun 2009
- Results posted
- No
- Data monitoring committee
- No
Publications
Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.
PubMed 39301879de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.
PubMed 23033926
Study at a glance
From the registry record, last updated by the sponsor on 30 Jun 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Recombinant Human Erythropoietin Use in ICU Patients: Does it Prevent Acute Renal Failure?
- ClinicalTrials.gov ID
- NCT00676234
- Acronym / sponsor ID
- 2008-11021991
- Conditions
- Acute Renal Failure
- Keywords
- erythropoietin
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- University Hospital, GenevaUniversity, hospital or other
- Study start
- May 2008
- Primary completion
- Jun 2009 (actual)
- Study completion
- Jun 2009 (actual)
- First posted
- 12 May 2008 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| 1 | No intervention | – |
| 2 | Experimental | Drug: epoetinumAdministration of intravenous rhu Epo on Day 0 |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (6 listed)
- Patients with malignant hypertension
- Patients with systolic BP > 150 mmHg at enrollment
- Patients with Hb level > 120g/L
- Patients with acute coronaropathy
- Pregnancy
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| epoetinumAlso: EprexAdministration 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 | Drug | 2 |
Primary outcome
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection
Time frame: 4 days
1 secondary outcome
mean change (%) from baseline in serum Cystatin C concentration at 96 hr after rhu EPO injection
Time frame: 4 days
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 30 Jun 2009.
- Derived from this study: PubMed 39301879Nishiwaki H, Abe Y, Suzuki T, Hasegawa T, Levack WM, Noma H, Ota E. Erythropoiesis-stimulating agents for preventing acute kidney injury. Cochrane Database Syst Rev. 2024 Sep 20;9(9):CD014820. doi: 10.1002/14651858.CD014820.pub2.
- Derived from this study: PubMed 23033926de Seigneux S, Ponte B, Weiss L, Pugin J, Romand JA, Martin PY, Saudan P. Epoetin administrated after cardiac surgery: effects on renal function and inflammation in a randomized controlled study. BMC Nephrol. 2012 Oct 3;13:132. doi: 10.1186/1471-2369-13-132.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Patrick Saudan, Dr principal investigator
Nephrology Unit Geneva University Hospitals
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing epoetinum in people with Acute Renal Failure, run by University Hospital, Geneva at 1 site in Switzerland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 2 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 30 Jun 2009. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Switzerland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
mean change (%) from baseline in urinary NGAL concentration at 96 hr after rhu EPO injection (time frame: 4 days). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00676234, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 30 Jun 2009.