DiabetesPhase 3NCT01364402
Prevention of Contrast Induced Nephropathy by Erythropoietin
A Phase 3 study testing Epoetin beta and Saline 0.9% in people with Diabetes and Chronic Kidney Insufficiency, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
Trial summary
This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Diabetes, Chronic Kidney Insufficiency
- What is being tested?
- Epoetin beta and Saline 0.9%
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 142 participants
- Where
- 1 siteIsrael
- Study dates
- Aug 2011to Dec 2013
- Phase
- Phase 3
- 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
- Over 18 years of age.
- Diabetic patients.
- eGFR < 60 ml/min/1.73m2.
- Scheduled for primary or elective PCI.
Who cannot join
- Non diabetic patients.
- Patients with eGFR ≥ 60 ml/min/1.73m2.
- Chronic renal replacement therapy.
- Subject with active malignancy.
- Subject with any known history of seizure disorders.
- Subject with polycythemia.
Show all 15Show fewer
- Uncontrolled hypertension.
- Known allergy or hypersensitivity to EPO.
- Use of EPO 1 week prior to randomization.
- Use of long acting EPO (CERA) during 1 month prior to randomization.
- Use of NAC or bicarbonate during 3 days prior to randomization.
- Contrast media exposure during the last 7 days before randomization.
- Pregnant or lactating women.
- Participation in other clinical trial.
- Refusal or inability to give informed consent due to mental or physical state.
Trial locations and contacts
1 site in 1 country.
Lilach Shema-Didi, RN, MPH contact
Israel1 site, 1 recruiting
- Recruiting
Western Galilee Hospital
Nahariya
Shaul Atar, MD, shaul.atar@naharia.health.gov.il
Batya Kristal, MD, batya.kristal@naharia.health.gov.il
About this study
Official title: Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.
The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.
Read the detailed description
Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).
The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.
- Conditions
- Diabetes, Chronic Kidney Insufficiency
- Being tested
- Epoetin beta, Saline 0.9%
- Keywords
- scheduled for PCI
- Medical subject headings
- Diabetes Mellitus, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Epoetin betaDrug
Also called Epoietin beta
50,000U intravenously
Saline 0.9%Drug
Also called Hydration
normal saline intravenously
| Study group | Role | What they receive |
|---|---|---|
| Erythropoietin | Experimental | Not described Receives: Drug: Epoetin beta |
| Placebo | Placebo comparator | Not described Receives: Drug: Saline 0.9% |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence of Contrast Induced Nephropathy(CIN)
Measured: 1-3 days after exposure to contrast media
Secondary outcomes (4)
Enzymatic infarct size
Will be measured by Troponin and CK
Measured: 6h and 12 h after exposure to contrast media
Hospital length of stay
Measured: participants will be followed for the duration of hospital stay, an expected average of 3 days
Renal replacement therapy
Measured: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Hospital mortality
Measured: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Jun 2011 (estimated)
- Study startAug 2011
- Primary completionAug 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for DiabetesStudies of the same condition, open and under way.
- 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 3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 142 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Western Galilee Hospital-Nahariya
- Sponsor type
- Other government
- Investigators
- Shaul Atar, MD, Principal investigator, Western Galilee Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01364402
- Sponsor's protocol ID
- EPO1
- Status last verified
- Sep 2011
- First submitted
- 24 May 2011
- Last updated
- 10 Oct 2012
- Results posted
- No
- Data monitoring committee
- Yes
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 39301879
Study at a glance
From the registry record, last updated by the sponsor on 10 Oct 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast Induced Nephropathy by Erythropoietin in Patients With Diabetes Mellitus and eGFR<60 ml/Min/1.73m2 Undergoing Percutaneous Coronary Intervention
- ClinicalTrials.gov ID
- NCT01364402
- Acronym / sponsor ID
- EPO1
- Conditions
- Diabetes, Chronic Kidney Insufficiency
- Keywords
- scheduled for PCI
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 142 participants (estimated)
- Lead sponsor
- Western Galilee Hospital-NahariyaOther government
- Study start
- Aug 2011
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 2 Jun 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.
This ia a prospective, randomized, double blind, placebo controlled trial. patients schedule for primary PCI or elective PCI will randomly allocated to receive either a single dose of EPO (Recormon, Roche, Epoetin beta) or saline intravenously before PCI.
The investigators assume that the incidence rate of CIN will be significantly lower in the EPO group compared to placebo. In addition, EPO administration will result in a decrease of infarct size.
Detailed description
Radiological procedures utilizing intravascular contrast media are being widely applied for both diagnostic and therapeutic purposes. This has resulted in the increasing incidence of procedure-related contrast-induced nephropathy (CIN), which was found to be associated with poor outcome including higher in-hospital mortality rates. Therefore, finding ways to prevent CIN is a valuable clinical and research goal. However, there are no current methods for efficient and cost-effective prevention CIN. Erythropoietin (EPO) has been shown to elicit tissue-protective effects in various experimental models and few clinical studies of acute kidney injury (AKI). Therefore, this prospective, randomized, double blind, placebo controlled trial aim to evaluate, for the first time, the effectiveness of EPO in the prevention of CIN after percutaneous coronary intervention (PCI).
The potential reno-protective effect of EPO is expected to reduce the incidence of the third leading cause of hospital-acquired acute kidney injury. The above together with a cardio-protective effect of EPO is expected to reduce patient's morbidity, mortality and the high health cost associated with CIN treatment.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Erythropoietin | Experimental | Drug: Epoetin beta |
| Placebo | Placebo comparator | Drug: Saline 0.9% |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Over 18 years of age.
- Diabetic patients.
- eGFR < 60 ml/min/1.73m2.
- Scheduled for primary or elective PCI.
Key exclusion criteria (15 listed)
- Non diabetic patients.
- Patients with eGFR ≥ 60 ml/min/1.73m2.
- Chronic renal replacement therapy.
- Subject with active malignancy.
- Subject with any known history of seizure disorders.
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 |
|---|---|---|
| Epoetin betaAlso: Epoietin beta50,000U intravenously | Drug | Erythropoietin |
| Saline 0.9%Also: Hydrationnormal saline intravenously | Drug | Placebo |
Primary outcome
Incidence of Contrast Induced Nephropathy(CIN)
Time frame: 1-3 days after exposure to contrast media
4 secondary outcomes
Enzymatic infarct size
Time frame: 6h and 12 h after exposure to contrast media
Hospital length of stay
Time frame: participants will be followed for the duration of hospital stay, an expected average of 3 days
Renal replacement therapy
Time frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Hospital mortality
Time frame: participants will be followed after PCI procedure till discharge, an expected average of 1-2 days
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 10 Oct 2012.
- 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.
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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.
Lilach Shema-Didi, RN, MPH contact
Shaul Atar, MD principal investigator
Western Galilee Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing Epoetin beta and Saline 0.9% in people with Diabetes and Chronic Kidney Insufficiency, run by Western Galilee Hospital-Nahariya at 1 site in Israel.
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 4 inclusion and 15 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: status not confirmed, as of the sponsor's last update on 10 Oct 2012. 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 Israel. 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Lilach Shema-Didi, RN, MPH (972-507887538, lilach_01@yahoo.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence of Contrast Induced Nephropathy(CIN) (time frame: 1-3 days after exposure to contrast media). 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 NCT01364402, which also lists 1 linked publication.
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 10 Oct 2012; AzTrials last refreshed its copy on 8 Nov 2026.