Acute Kidney FailurePhase 1/2NCT00252200
BNP (Nesiritide) vs. Placebo to Protect Kidney Function in Patients Undergoing Heart Bypass Surgery.
A Phase 1/2 study testing Neseritide in people with Acute Kidney Failure, run by Mayo Clinic at 1 site in United States.
Trial summary
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Failure
- What is being tested?
- Neseritide
- Type of treatment
- Injection or infusion
- How many people
- 40 participants
- Where
- 1 siteUnited States
- Study dates
- Mar 2003to Oct 2007
- Phase
- Phase 1/2
- 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 > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent.
Who cannot join
- Cardiogenic shock or hypotension with systolic BP < 90 mmHg.
- Patients with acute or chronic aortic dissection.
- Patients who are enrolled in other studies that have an effect the renal function.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
Read the detailed description
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.
- Conditions
- Acute Kidney Failure
- Being tested
- Neseritide
- 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.
NeseritideDrug
Also called BNP, Nesiritide
Dose of Nesiritide infusion will be 0.005 ug/Kg/min
What is being measured
The primary outcome is the main question the study is designed to answer.
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Measured: 72 hours post op
Secondary outcomes (5)
Number of patients requiring dialysis during the hospitalization
Measured: before hospital discharge
Plasma aldosterone levels at 12 hours and 24 hours
Measured: 12 hours and 24 hours postoperatively
Total time on ventilator, ICU length of stay, total length of stay in hospital
Measured: total length of hospital stay
pre and postoperative diuretic dose used
Measured: pre operative and postoperate
Need or absence of need for inotropic support in the 72 hour perioperative period
Measured: 72 hours perioperative
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted11 Nov 2005 (estimated)
- Study startMar 2003
- Primary completionOct 2007
- Study completionOct 2007
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute Kidney FailureStudies of the same condition, open and under way.
- More trials run by Mayo ClinicThe 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 1/2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 40 participants (actual)
Sponsor and investigators
- Lead sponsor
- Mayo Clinic
- Sponsor type
- University, hospital or other
- Collaborators
- Scios, Inc.
- Investigators
- Horng H. Chen, M.D., Principal investigator, Mayo Clinic
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00252200
- Sponsor's protocol ID
- 621-03
- Status last verified
- Sep 2009
- First submitted
- 10 Nov 2005
- Last updated
- 23 Sep 2009
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Sep 2009. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Low Dose Continuous Infusion of BNP (Nesiritide) in the Prevention of Renal Insufficiency Post Cardiopulmonary Bypass Cardiac Surgery.
- ClinicalTrials.gov ID
- NCT00252200
- Acronym / sponsor ID
- 621-03
- Conditions
- Acute Kidney Failure
- Phase
- Phase 1/2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 40 participants (actual)
- Lead sponsor
- Mayo ClinicUniversity, hospital or other
- Collaborators
- Scios, Inc.
- Study start
- Mar 2003
- Primary completion
- Oct 2007 (actual)
- Study completion
- Oct 2007 (actual)
- First posted
- 11 Nov 2005 (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.
Use of BNP (nesiritide) vs placebo to help protect kidney function in patients undergoing heart bypass surgery.
Detailed description
This is a randomized, double-blind, placebo controlled study of low dose nesiritide to prevent renal insufficiency after cardiopulmonary bypass surgery. Patients included are those with greater than mild renal insufficiency preoperatively as defined by having a creatinine clearance of less than 50 mL/minute determined by the Cockroft-Gault formula. The infusion of nesiritide (BNP) 0.005 mcg/Kg/minute or placebo begins 1 hour before surgery and runs for 24 hours started after the induction of anesthesia prior to cardiopulmonary bypass.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind (participant, care provider, investigator)
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients > 18 years old, undergoing cardiac surgery requiring cardiopulmonary bypass with baseline creatinine clearance < 50 ml/min and who are not dialysis dependent.
Key exclusion criteria (3 listed)
- Cardiogenic shock or hypotension with systolic BP < 90 mmHg.
- Patients with acute or chronic aortic dissection.
- Patients who are enrolled in other studies that have an effect the renal function.
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 |
|---|---|---|
| NeseritideAlso: BNP, NesiritideDose of Nesiritide infusion will be 0.005 ug/Kg/min | Drug | – |
Primary outcome
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula
Time frame: 72 hours post op
5 secondary outcomes
Number of patients requiring dialysis during the hospitalization
Time frame: before hospital discharge
Plasma aldosterone levels at 12 hours and 24 hours
Time frame: 12 hours and 24 hours postoperatively
Total time on ventilator, ICU length of stay, total length of stay in hospital
Time frame: total length of hospital stay
pre and postoperative diuretic dose used
Time frame: pre operative and postoperate
Need or absence of need for inotropic support in the 72 hour perioperative period
Time frame: 72 hours perioperative
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 23 Sep 2009.
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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.
Horng H. Chen, M.D. principal investigator
Mayo Clinic
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1/2 study testing Neseritide in people with Acute Kidney Failure, run by Mayo Clinic at 1 site in United States.
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 1 inclusion and 3 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 23 Sep 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 United States. 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 combined phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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?
Creatinine Clearance at 72 hours determined by the Cockroft-Gault formula (time frame: 72 hours post op). 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 23 Sep 2009.