Acute Kidney InjuryPhase 2/3NCT01197235
Effect of Darbepoetin in Contrast-induced Nephropathy
A Phase 2/3 study testing darbepoetin-α and isotonic saline in people with Acute Kidney Injury, run by Seoul National University Bundang Hospital at 1 site in South Korea.
Trial summary
The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- darbepoetin-α and isotonic saline
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 80 participants
- Where
- 1 siteSouth Korea
- Study dates
- May 2009to Dec 2015
- Phase
- Phase 2/3
- 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
- age over 18 yr
- estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m2
Who cannot join
- Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
- Pregnancy or lactation
- Use of contrast agent within 1 week
- Emergent CAG or PCI
- Not recovered from AKI(acute kidney injury)
- Use of nephrotoxic drugs within 48 hr
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- Cardiogenic shock (SBP(systolic blood pressure) < 90 mmHg) or pulmonary edema
- Uncontrolled hypertension (SBP ≥ 200 mmHg or DBP(diastolic blood pressure) ≥ 130 mmHg)
- History of hypersensitivity to contrast agent
- Known allergy or hypersensitivity to EPO(erythropoietin)
- Use of EPO within 1 month
- Anemia (hemoglobin < 9 g/dL)
- Ventilatory care
Trial locations and contacts
1 site in 1 country.
South Korea1 site
Seoul National University Bundang Hospital,
Seongnam, 463-707
About this study
Official title: Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease
The purpose of this study is to determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.
Read the detailed description
Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN.
Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments.
In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.
- Conditions
- Acute Kidney Injury
- Being tested
- darbepoetin-α, isotonic saline
- Keywords
- darbepoetin, chronic kidney disease, coronary angiography
- Medical subject headings
- Acute Kidney Injury, Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
darbepoetin-αDrug
Also called aranesp
Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography
isotonic salineDrug
Also called 0.9% NaCl solution
Infusion of isotonic saline will be performed 1 hour before angiography
| Study group | Role | What they receive |
|---|---|---|
| darbepoetin-α | Experimental | Infusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography Receives: Drug: darbepoetin-α |
| isotonic saline | Placebo comparator | Infusion of isotonic saline will be performed 1 hour before angiography Receives: Drug: isotonic saline |
What is being measured
The primary outcome is the main question the study is designed to answer.
incidence of contrast-induced nephropathy (CIN)
a greater than 25 percent increase in serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using the contrast agent
Measured: 48 hours
Secondary outcomes (1)
maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)
the maximum difference in Cr levels before and after CAG or PCI, the incidence of AKI requiring renal replacement therapy, length of hospital stay, mortality, myocardial infarction, revascularization, and the occurrence of stroke
Measured: 1 month after the intervention
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Sep 2010 (estimated)
- Study startMay 2009
- Primary completionDec 2015 (estimated)
- Study completionDec 2015 (estimated)
Why it stopped: difficult to enroll targeted participants
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by Seoul National University Bundang HospitalThe 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 80 participants (actual)
Sponsor and investigators
- Lead sponsor
- Seoul National University Bundang Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Responsible party
- Principal investigator, Ki Young Na, Seoul National University Bundang Hospital
- Investigators
- Ki Young Na, MD PhD, Principal investigator, Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01197235
- Sponsor's protocol ID
- SNUBH B- 0811/063-001
- Status last verified
- Nov 2014
- First submitted
- 8 Sep 2010
- Last updated
- 21 Nov 2014
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 21 Nov 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prevention of Contrast-Induced Nephropathy by Darbepoetin in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01197235
- Acronym / sponsor ID
- SNUBH B- 0811/063-001
- Conditions
- Acute Kidney Injury
- Keywords
- darbepoetin, chronic kidney disease, coronary angiography
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: difficult to enroll targeted participants
- Enrolment
- 80 participants (actual)
- Lead sponsor
- Seoul National University Bundang HospitalUniversity, hospital or other
- Collaborators
- SMG-SNU Boramae Medical Center
- Study start
- May 2009
- Primary completion
- Dec 2015 (estimated)
- Study completion
- Dec 2015 (estimated)
- First posted
- 9 Sep 2010 (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 determine whether the drug that produce red blood cells is effective in the prevention of kidney dysfunction after coronary angiography in patients with chronic kidney disease.
Detailed description
Use of radiocontrast agent is inevitable in computed tomography or angiography. However, contrast agent can aggravate kidney function. Contrast-induced nephropathy (CIN) refers to the clinical situation where decreased kidney function after use of contrast. CIN is the 3rd most common cause of acute kidney injury in the hospitals. There are a lot of reports that death rate is increased in patients with CIN.
Erythropoietin is an agent that treat anemia. It also has been reported to have a tissue-protective effect in the animal experiments.
In this study, we hypothesized that erythropoietin can reduce the incidence of CIN in patients with chronic kidney disease undergoing coronary angiography.
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 |
|---|---|---|
| darbepoetin-α | Experimental | Drug: darbepoetin-αInfusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography |
| isotonic saline | Placebo comparator | Drug: isotonic salineInfusion of isotonic saline will be performed 1 hour before angiography |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- age over 18 yr
- estimated glomerular filtration rate (GFR) < 60 ml/min/1.73m2
Key exclusion criteria (13 listed)
- Chronic renal replacement therapy (hemodialysis, peritoneal dialysis, continuous renal replacement therapy)
- Pregnancy or lactation
- Use of contrast agent within 1 week
- Emergent CAG or PCI
- Not recovered from AKI(acute kidney injury)
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 |
|---|---|---|
| darbepoetin-αAlso: aranespInfusion of darbepoetin-α 1.5 μg/kg will be performed 1 hour before angiography | Drug | darbepoetin-α |
| isotonic salineAlso: 0.9% NaCl solutionInfusion of isotonic saline will be performed 1 hour before angiography | Drug | isotonic saline |
Primary outcome
incidence of contrast-induced nephropathy (CIN)
Time frame: 48 hours
a greater than 25 percent increase in serum Cr or an absolute increase in serum Cr of 0.5 mg/dL within 48 hours after using the contrast agent
1 secondary outcome
maximum difference in Cr levels before and after CAG(coronary angiography) or PCI(percutaneous coronary intervention)
Time frame: 1 month after the intervention
Results and safety
The study was stopped early (reason given: difficult to enroll targeted participants). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 21 Nov 2014.
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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.
Ki Young Na, MD PhD principal investigator
Seoul Ntional University Bundang Hospital, Seoul National University College of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing darbepoetin-α and isotonic saline in people with Acute Kidney Injury, run by Seoul National University Bundang Hospital at 1 site in South Korea.
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 13 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: stopped early, as of the sponsor's last update on 21 Nov 2014. 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 South Korea. 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 combined 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.
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?
The study was stopped early (reason given: difficult to enroll targeted participants). Results are not available in the source record.
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?
incidence of contrast-induced nephropathy (CIN) (time frame: 48 hours). 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 21 Nov 2014.