Acute Kidney InjuryPhase 4NCT02467075
Double-Blind Placebo-Controlled CIN Trial
A Phase 4 study testing Iopamidol 300 (Contrast) in people with Acute Kidney Injury, run by University of Michigan at 1 site in United States.
Trial summary
This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV 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?
- Iopamidol 300 (Contrast)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1 participants
- Where
- 1 siteUnited States
- Study dates
- Jul 2015to Sep 2015
- Phase
- Phase 4
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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
- Inpatients scheduled for CT scan of abdomen and/or pelvis
- Had surgery in the last 4 weeks
- Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT)
- Suspected infection or fluid collection in abdomen and/or pelvis
Who cannot join
- Pregnant
- Severe Allergy (anaphylaxis) to contrast
- Dialysis in last 7 days
- Received intravascular iodinated contrast in last 48 hours
- CT of abdomen and pelvis in last 7 days shows no fluid collection
- Prisoners
- CT ordered for an indication that requires (eg, CT angiogram) or contraindicates (eg, renal stone CT) the administration of intravascular contrast
Trial locations and contacts
1 site in 1 country.
United States1 site
University of Michigan Hospital Department of Radiology
Ann Arbor, Michigan, 48109
About this study
Official title: Phase IV Randomized Double-Blinded Placebo-Controlled Noninferiority Study of the Effect of Intravenous Low-Osmolality Iodinated Contrast Material On Renal Function in Postoperative Adults With Stage IIIb or Stage IV Chronic Kidney Disease
This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.
Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
Read the detailed description
This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.
Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria.
Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours before and after the CT..
- Conditions
- Acute Kidney Injury
- Being tested
- Iopamidol 300 (Contrast), Placebo (Normal Saline)
- Keywords
- CT, iodinated contrast, contrast-induced AKI, kidney injury
- 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.
Iopamidol 300 (Contrast)Drug
Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan
Placebo (Normal Saline)Drug
Also called Normal saline
Patients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan
| Study group | Role | What they receive |
|---|---|---|
| Iopamidol 300 (Contrast) | Active comparator | Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT. Receives: Drug: Iopamidol 300 (Contrast) |
| Placebo (Normal Saline) | Placebo comparator | Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT. Receives: Drug: Placebo (Normal Saline) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Participants With Stage II AKI (Acute Kidney Injury)
Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.
Measured: 48 hours
Secondary outcomes (5)
Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition
Stage I AKI, traditional CIN definitions or other definitions of AKI (acute kidney injury) at lower levels of severity
Measured: 48-72 hours
Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)
Number of subjects that require renal (kidney) replacement therapy, such as a kidney transplant or dialysis within 30 days of study participation.
Measured: 30 days
Hospital Length of Stay
Subject's hospital length of stay in days
Measured: Duration of hospital stay (assessed from date of randomization up to 30 days)
30-day Readmission
Number of times a subject is readmitted within 30 days of study recruitment
Measured: 30 days
Mortality Rate - 30 Day
Number of subjects who died within 30 days of entry into the study.
Measured: 30 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jun 2015 (estimated)
- Study startJul 2015
- Primary completionSep 2015
- Study completionSep 2015
Why it stopped: Insufficient number of subjects could be enrolled.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Other trials for Acute Kidney InjuryStudies of the same condition, open and under way.
- More trials run by University of MichiganThe 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 4
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 1 participants (actual)
Sponsor and investigators
- Lead sponsor
- University of Michigan
- Sponsor type
- University, hospital or other
- Collaborators
- Radiological Society of North America
- Responsible party
- Principal investigator, Matthew Davenport, MD, University of Michigan
- Investigators
- Matthew Davenport, MD, Principal investigator, University of Michigan
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02467075
- Sponsor's protocol ID
- HUM 00097944
- Status last verified
- May 2017
- First submitted
- 3 Jun 2015
- Last updated
- 27 Jun 2017
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Phase IV Randomized Double-Blinded Placebo-Controlled Noninferiority Study of the Effect of Intravenous Low-Osmolality Iodinated Contrast Material On Renal Function in Postoperative Adults With Stage IIIb or Stage IV Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT02467075
- Acronym / sponsor ID
- HUM 00097944
- Conditions
- Acute Kidney Injury
- Keywords
- CT, iodinated contrast, contrast-induced AKI, kidney injury
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Insufficient number of subjects could be enrolled.
- Enrolment
- 1 participants (actual)
- Lead sponsor
- University of MichiganUniversity, hospital or other
- Collaborators
- Radiological Society of North America
- Study start
- Jul 2015 (actual)
- Primary completion
- Sep 2015 (actual)
- Study completion
- Sep 2015 (actual)
- First posted
- 9 Jun 2015 (estimated)
- Results
- Posted 27 Jun 2017
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This double-blinded placebo-controlled study will examine the incidence and significance of contrast-induced acute kidney injury following IV iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.
Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN (Acute Kidney Injury Network) criteria.
Detailed description
This double-blinded placebo-controlled non-inferiority study will examine the incidence and significance of contrast-induced acute kidney injury following intravenous iodine-based contrast material administration in subjects with stage IIIB or stage IV chronic kidney disease.
Subjects will be scheduled for clinically indicated CT of the abdomen and/or pelvis to evaluate for suspected intra-abdominal infection. Subjects will be randomized to receive either weight-based low-osmolality iodinated contrast material or saline. The primary outcome measure will be the incidence of stage II AKI by AKIN criteria.
Secondary outcome measures will include AKI by other definitions (stage I AKI, traditional CI-AKI definition), hospital length of stay, 30-day readmission rate, number of additional percutaneous interventions within 30 days, number of additional CT examinations within 30 days, and 30-day mortality rate. All subjects will receive a minimum of 1 mL/kg/hr (max: 125 mL/hr) of volume expansion for at least three hours before and after the CT..
Study design
- Primary purpose
- Other
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iopamidol 300 (Contrast) | Active comparator | Drug: Iopamidol 300 (Contrast)Subjects scheduled for a clinical CT will be randomized to receive weight-based low-osmolality iodinated contrast with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT. |
| Placebo (Normal Saline) | Placebo comparator | Drug: Placebo (Normal Saline)Subjects scheduled for a standard of care CT will be randomized to receive weight-based normal saline instead of contrast material with the CT. All subjects will receive a minimum of 1 mL/kg/hr of isotonic volume expansion for at least three hours before and three hours after the CT. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Inpatients scheduled for CT scan of abdomen and/or pelvis
- Had surgery in the last 4 weeks
- Stable renal function (based on serum creatinine-last two lab values +/- 0.3 of each other, with most recent within 5 days of CT)
- Suspected infection or fluid collection in abdomen and/or pelvis
Key exclusion criteria (7 listed)
- Pregnant
- Severe Allergy (anaphylaxis) to contrast
- Dialysis in last 7 days
- Received intravascular iodinated contrast in last 48 hours
- CT of abdomen and pelvis in last 7 days shows no fluid collection
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 |
|---|---|---|
| Iopamidol 300 (Contrast)Patients will be randomized to receive IV iopamidol 300 (1.25 mL/kg, max 125 mL) with their CT scan | Drug | Iopamidol 300 (Contrast) |
| Placebo (Normal Saline)Also: Normal salinePatients will be randomized to receive IV normal saline (1.25 mL/kg, max 125 mL) with their CT scan | Drug | Placebo (Normal Saline) |
Primary outcome
Participants With Stage II AKI (Acute Kidney Injury)
Time frame: 48 hours
Participants who had Stage II AKI. This is measured by comparing an initial blood creatinine level with the level at 48 hours. Creatine is a chemical waste product that passes through the kidneys. Creatinine levels reflect how well the kidneys are working.
5 secondary outcomes
Subjects With AKI (Acute Kidney Injury), Stage 1 or Other Definition
Time frame: 48-72 hours
Subjects Requiring Renal Replacement Therapy (Kidney Transplant or Dialysis)
Time frame: 30 days
Hospital Length of Stay
Time frame: Duration of hospital stay (assessed from date of randomization up to 30 days)
30-day Readmission
Time frame: 30 days
Mortality Rate - 30 Day
Time frame: 30 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 27 Jun 2017.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Individual participant dataSharing planned: No
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Peripheral Arterial Disease, Chronic Kidney Diseases
Not yet recruitingObservational study
Cumulative Intra-Abdominal Pressure Burden and Acute Kidney Injury After Emergency Abdominal Surgery
Acute Kidney Injury, Intra-Abdominal Hypertension
Not yet recruitingObservational study
Vancomycin Exposure and Biomarker Tracking Using Real-time Monitoring of Interstitial Fluid
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Neutrophil and Monocyte Deactivation Via the SeLective CytopheretIc Device - A Randomized Clinical Trial in Acute Kidney Injury
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Recruiting
NIRS Monitoring in the NICU and AKI
Acute Kidney Injury (AKI), Postnatal AKI
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.
Matthew Davenport, MD principal investigator
University of Michigan
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iopamidol 300 (Contrast) in people with Acute Kidney Injury, run by University of Michigan 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 4 inclusion and 7 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 27 Jun 2017. 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
Yes. Results are posted in the registry (first posted 27 Jun 2017). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Participants With Stage II AKI (Acute Kidney Injury) (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 27 Jun 2017; AzTrials last refreshed its copy on 27 Oct 2026.