Kidney FailurePhase 2EPRICSNCT01423955
Erythropoietin (EPO) to Protect Renal Function After Cardiac Surgery
A Phase 2 study testing Erythropoietin zeta in people with Kidney Failure and Renal Failure, run by Region Skane at 1 site in Sweden.
Trial summary
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Renal Failure
- What is being tested?
- Erythropoietin zeta
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 75 participants
- Where
- 1 siteSweden
- Study dates
- Oct 2011to Apr 2013
- 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
- The patient is scheduled for non-emergent CABG surgery.
- CyC eGFR or MDRD eGFR < 60 ml/min.
- The patient has given his/her written consent to participate
Who cannot join
- The patient has an uncontrolled hypertension.
- Hypersensitivity to the active drug.
- The patient is pregnant or is a fertile woman (<50 years).
- The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
- Preoperative CyC eGFR or MDRD eGFR is < 15, or the patient is treated with dialysis.
- The patient has a known malignancy.
Show all 9Show fewer
- The patient is planned for Off-pump CABG surgery.
- The patient is included in other ongoing clinical trial. Yes / No
- Clinically judgment by the investigator that the patient should not participate in the study.
Trial locations and contacts
1 site in 1 country.
Sweden1 site
Dept Thoracic Surgery, Anestesia and Intensive Care, SUS-Lund
Lund, 221 85
About this study
Official title: EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.
Read the detailed description
Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.
Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.
Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.
- Conditions
- Kidney Failure, Renal Failure
- Being tested
- Erythropoietin zeta, Placebo
- Keywords
- Erythropoietin, Erythropoetin, Cardiac surgery, Ischemia, Reperfusion, Renal function, Cystatin C, Creatinine, Safety
- Medical subject headings
- Renal Insufficiency, Ischemia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Erythropoietin zetaDrug
Also called Active substance: Erythropoietin zeta, Drug brand name: Retacrit®, Manufacturer and Provider: Hospira, ATC-code: B03XA01
The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse.
PlaceboDrug
Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg.
| Study group | Role | What they receive |
|---|---|---|
| Placebo | Placebo comparator | Placebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg. Receives: Drug: Placebo |
| Erythropoietin | Experimental | • Active substance: Erythropoietin zeta with the ATC-code: B03XA01. The drug is a Clear colorless solution for injection. The active substance will be diluted with NaCl 9mg/ml to a to a concentration of 2000 U/ml. A dose of 400U/kg will be prepared and marked before the operation. The drug will be administrated after the anesthesia induction and before the start of surgery. Receives: Drug: Erythropoietin zeta |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in plasma cystatin C measured on day 3 postoperatively.
Measured: 3 days postoperatively
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Aug 2011 (estimated)
- Study startOct 2011
- Primary completionJan 2013
- Study completionApr 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Kidney FailureStudies of the same condition, open and under way.
- More trials run by Region SkaneThe 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
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 75 participants (actual)
Sponsor and investigators
- Lead sponsor
- Region Skane
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Henrik Bjursten, M.D. Ph.D, Principal investigator, Region Skane
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01423955
- Sponsor's protocol ID
- 2011-001673-70
- Acronym
- EPRICS
- Status last verified
- Oct 2013
- First submitted
- 24 Aug 2011
- Last updated
- 25 Oct 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 25 Oct 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- EPO to Protect Renal Function After Cardiac Surgery. A Phase II Double Blind Randomized Controlled Study.
- ClinicalTrials.gov ID
- NCT01423955
- Acronym / sponsor ID
- EPRICS / 2011-001673-70
- Conditions
- Kidney Failure, Renal Failure
- Keywords
- Erythropoietin, Erythropoetin, Cardiac surgery, Ischemia, Reperfusion, Renal function, Cystatin C, Creatinine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 75 participants (actual)
- Lead sponsor
- Region SkaneUniversity, hospital or other
- Study start
- Oct 2011
- Primary completion
- Jan 2013 (actual)
- Study completion
- Apr 2013 (actual)
- First posted
- 26 Aug 2011 (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.
The purpose of this study is to evaluate the potential of erythropoietin in reducing risk and degree of acute kidney injury after cardiac surgery.
Detailed description
Acute kidney injury is a common complication after cardiac surgery and is associated with decreased long-term survival.
Several experimental and animal studies have showed cytoprotective, preconditioning and anti-apoptotic effects of high dose erythropoietin. Clinical studies in human have also suggested that high dose erythropoietin has preconditioning effects against injury after ischemia and reperfusion on different organs in human, such as brain, heart, liver, and kidneys.
Administration of Epo in high doses in conjunction with cardiac surgery has shown to be safe with no direct side-effects.
The investigators therefore hypothesize that a preconditioning effect of erythropoietin before cardiac surgery can reduce the level of renal dysfunction after surgery in a group with preoperative renal impairment.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Placebo | Placebo comparator | Drug: PlaceboPlacebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg. |
| Erythropoietin | Experimental | Drug: Erythropoietin zeta• Active substance: Erythropoietin zeta with the ATC-code: B03XA01. The drug is a Clear colorless solution for injection. The active substance will be diluted with NaCl 9mg/ml to a to a concentration of 2000 U/ml. A dose of 400U/kg will be prepared and marked before the operation. The drug will be administrated after the anesthesia induction and before the start of surgery. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- The patient is scheduled for non-emergent CABG surgery.
- CyC eGFR or MDRD eGFR < 60 ml/min.
- The patient has given his/her written consent to participate
Key exclusion criteria (9 listed)
- The patient has an uncontrolled hypertension.
- Hypersensitivity to the active drug.
- The patient is pregnant or is a fertile woman (<50 years).
- The patient has been treated with Erythropoietin within 4 weeks prior to the surgery.
- Preoperative CyC eGFR or MDRD eGFR is < 15, or the patient is treated with dialysis.
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 |
|---|---|---|
| Erythropoietin zetaAlso: Active substance: Erythropoietin zeta, Drug brand name: Retacrit®, Manufacturer and Provider: Hospira, ATC-code: B03XA01The active drug will be given only once after the anesthesia induction and before the start of surgery. The active drug will be diluted to 2000U/kg and given as a single dose of 400U/kg. The dose will be prepared prior to surgery by a independent nurse. | Drug | Erythropoietin |
| PlaceboPlacebo arm will receive NaCl 9mg/ml with a dose of 0.2 ml/kg. The placebo dose will be prepared prior to the surgery by a independent nurse. The calculated volume will match the volume of the active durg. | Drug | Placebo |
Primary outcome
Change in plasma cystatin C measured on day 3 postoperatively.
Time frame: 3 days postoperatively
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 25 Oct 2013.
Related trials for Kidney Failure
Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
RecruitingPhase 3
Study to Assess the Efficacy, Pharmacokinetics, Safety and Tolerability of Atrasentan in Pediatric Patients With Primary IgAN
Berger Disease, Bergers Disease
RecruitingPhase 1
Serial Amnioinfusions as Regenerative Therapy for Pulmonary Hypoplasia
Renal Failure Congenital, Congenital Renal Anomaly Nos
Recruiting
NightWare and Cardiovascular Health in Women With PTSD
Post Traumatic Stress Disorder, Cardiovascular Diseases
Recruiting
Investigating Vascular Properties of HEMI and SPG Signals in Individuals With or at Risk for Chronic Kidney Disease
Chronic Kidney Disease, Hypertension (HTN)
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.
Henrik Bjursten, M.D. Ph.D principal investigator
Region Skane
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 Erythropoietin zeta in people with Kidney Failure and Renal Failure, run by Region Skane at 1 site in Sweden.
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 3 inclusion and 9 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 25 Oct 2013. 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 Sweden. 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. Some participants in this study may receive a placebo. 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?
Change in plasma cystatin C measured on day 3 postoperatively. (time frame: 3 days postoperatively). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 25 Oct 2013.