Chronic Renal ImpairmentPhase 4RECARENCT00782639

Renal Safety of Iopamidol Versus Iodixanol During Coronary Angiography in Diabetic Patients

A Phase 4 study testing Iopamidol injection 76% and iodixanol in people with Chronic Renal Impairment and Diabetes Mellitus, run by Bracco Diagnostics, Inc at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

The purpose of this study is to compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with moderate-to-severe chronic kidney disease and diabetes mellitus undergoing cardiac angiography. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Renal Impairment, Diabetes Mellitus
What is being tested?: Iopamidol injection 76% and iodixanol
Type of treatment: Injection or infusion
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 23 participants
Where: 1 siteUnited States
Study dates: Mar 2009to Sep 2009
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

Provides written Informed Consent and is willing to comply with protocol requirements
Is >18 years of age
Has a documented predose serum creatinine level of ≥1.5 mg/dL for men and ≥1.3 mg/dL for women or predose eGFR of >15 and ≤50 mL/min/1.73 m2, calculated via the Modification of Diet in Renal Disease (MDRD) formula from a SCr obtained within 72 hours of enrollment into the study;
Diagnosed as having diabetes mellitus (Type 1 or Type 2) treated with insulin or oral hypoglycemic agents for at least 6 months
Is referred for cardiac angiography with or without percutaneous coronary intervention;
If at the discretion of the Investigator is receiving or will be receiving a prophylactic medication for renal function, the medication is one that is permitted by this protocol (N acetylcysteine, 1200 mg twice daily on the day before and on the day of the cardiac angiography procedure);
Undergoes or is scheduled to undergo pre, peri, or post procedure hydration permitted by this protocol, i.e.:
154 mEq/L sodium bicarbonate solution, administered intravenously at 3 mL/kg/hr for 1 hour before cardiac angiography, followed by an infusion of 1 mL/kg/hr during and out to 6 hours after cardiac angiography, or 154 mEq/L sodium chloride solution (0.9% normal saline), administered intravenously at 1 mL/kg/hr for 8 12 hours before cardiac angiography, followed by an infusion of 1 mL/kg/hr during and out to 8-12 hours after cardiac angiography

Who cannot join

-Is a pregnant or lactating female. Exclude the possibility of pregnancy: by laboratory testing on-site at the institution (measurement of serum or urine beta human chorionic gonadotropin) within 24 hours prior to the start of investigational product administration by history (e.g., tubal ligation or hysterectomy, post menopausal with a minimum 1 year without menses)
Has a history of hypersensitivity to iodine-containing compounds;
Has unstable renal function (i.e., acute worsening of renal function, as determined by the Investigator, that has been observed in the 7 days prior to enrollment) and/or is in acute renal failure;
Has stage 5 chronic kidney disease or end-stage renal disease (i.e., estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m2)
Has severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association (NYHA);
Has uncontrolled diabetes, as determined by the Investigator;

Show all 15Show fewer

Has received an iodinated contrast agent within 7 days prior to the administration of the study agent or is scheduled to receive an iodinated contrast agent within 72 hours after administration of the study agent;
Is receiving cyclo-oxygenase-2 inhibitors, nonsteroidal anti-inflammatory drugs (with exception of low dose aspirin [≤325 mg per day]), aminoglycosides, or any other drugs that carry a significant risk of nephrotoxicity (in the opinion of the Investigator) during the time period beginning within 72 hours prior to contrast administration and up to 72 hours postdose;
Prior to, during or post the cardiac angiography, is receiving or will be receiving a prophylactic medication to prevent acute kidney injury that is not permitted by this protocol (e.g., theophylline, fenoldopam, etc.);
During cardiac angiography, is going to receive provocative pharmacological agents such as adenosine or dipyridamole;
Is planned to undergo major surgery (e.g. coronary artery bypass graft, valve surgery, etc.) within 48-72 hours after contrast administration;
Is planned to receive an intravenous diuretic or mannitol as prophylaxis to prevent acute renal injury (Note: chronic administration is allowed);
Is hemodynamically unstable within 48 hours pre-contrast administration defined as a systolic blood pressure <90 mmHg or requires pressor or intra-aortic balloon support;
Has any medical condition or other circumstances which would significantly decrease the chances of obtaining reliable data, achieving study objectives, or completing the study and/or postdose follow-up examinations;
Is determined by the Investigator that the patient is clinically unsuitable for the study Note: Changes in diuretics, angiotensin-converting enzyme inhibitors, or angiotensin receptor blockers doses within 72 hours prior to and up to 72 hours post contrast administration should be avoided unless clinically necessary for the subject's underlying medical condition.

Trial locations and contacts

1 site in 1 country.

United States1 site

Bracco Diagnostics Inc.
Princeton, New Jersey, 08540

Other trials in United States

About this study

Official title: RECARE (REnal Safety Following the Intra-Arterial Administration of Iopamidol vs. Iodixanol During Coronary AngiogRaphy in DiabEtic Patients)

Read the detailed description

This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with:

Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and
Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures. Approximately 10 investigative centers were to participate in this study. This study was to enroll approximately 220 patients to ensure that 200 evaluable patients were able to complete the study according to this protocol.

Patients were to be randomized to receive either iopamidol-370 or iodixanol-320. Each patient was to be evaluated for the occurrence of CIN within 48 to 72 hours postdose.

Conditions: Chronic Renal Impairment, Diabetes Mellitus
Being tested: Iopamidol injection 76%, iodixanol
Medical subject headings: Renal Insufficiency, Chronic, Diabetes Mellitus

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Iopamidol injection 76%Drug
Also called Isovue
Iopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution
iodixanolDrug
Visipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution

Study groups in NCT00782639
Study group	Role	What they receive
Iopamiro-370	Active comparator	Not described Receives: Drug: Iopamidol injection 76%
Visipaque 320	Active comparator	Not described Receives: Drug: iodixanol

What is being measured

The primary outcome is the main question the study is designed to answer.

The Number of Participants With Contrast-induced Nephropathy (CIN)
The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Measured: 48 to 72 hours After Injection of Contrast Media
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Measured: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media

Secondary outcomes (4)

The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)
This outcome measure provides the total number of participants that had a decrease from baseline in eGFR greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
Measured: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)
This outcome measure provides the total number of participants that had a increase from baseline in SCr greater or equal to 25% within 48 to 72 hours following the cardiac angiography procedure.
Measured: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
Number of Participants Requiring Dialysis
This outcome measure provides the total number of participants requiring dialysis occurring from acute renal failure.
Measured: 48 to 72 hours after injection of contrast media
Number of Participants Who Died From Acute Renal Failure
This outcome measure provides the total number of participants who died as a result of acute renal failure.
Measured: Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 2009Sep 2009

First posted31 Oct 2008 (estimated)
Study startMar 2009
Primary completionSep 2009
Study completionSep 2009

Why it stopped: This study was terminated early due to slow enrollment.

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 Chronic Renal ImpairmentStudies 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 4
Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind
Who is masked: Participant, Care provider, Investigator
Enrolment: 23 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00782639
Sponsor's protocol ID: IOP114
Acronym: RECARE
Status last verified: Jan 2012
First submitted: 28 Oct 2008
Last updated: 26 Jan 2012
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

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Study at a glance

From the registry record, last updated by the sponsor on 26 Jan 2012. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: RECARE (REnal Safety Following the Intra-Arterial Administration of Iopamidol vs. Iodixanol During Coronary AngiogRaphy in DiabEtic Patients)
ClinicalTrials.gov ID: NCT00782639
Acronym / sponsor ID: RECARE / IOP114
Conditions: Chronic Renal Impairment, Diabetes Mellitus
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: This study was terminated early due to slow enrollment.
Enrolment: 23 participants (actual)
Lead sponsor: Bracco Diagnostics, IncIndustry (pharma, biotech, devices)
Study start: Mar 2009
Primary completion: Sep 2009 (actual)
Study completion: Sep 2009 (actual)
First posted: 31 Oct 2008 (estimated)
Results: Posted 1 Sep 2011

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

Detailed description

This was a Phase IV, multicenter, randomized, double-blind, parallel-group comparison of iopamidol-370 and iodixanol-320 in patients at high risk for CIN, i.e., patients with:

Stage 3 or 4 CKD (SCr level of ≥ 1.5 mg/dL for men and ≥1.3 mg/dL for women or eGFR between 15 and 50 mL/min, and
Diabetes mellitus who would undergo clinically indicated cardiac angiography procedures. Approximately 10 investigative centers were to participate in this study. This study was to enroll approximately 220 patients to ensure that 200 evaluable patients were able to complete the study according to this protocol.

Patients were to be randomized to receive either iopamidol-370 or iodixanol-320. Each patient was to be evaluated for the occurrence of CIN within 48 to 72 hours postdose.

Study design

Primary purpose: Diagnosis
Allocation: Randomised
Intervention model: Parallel groups
Masking: Triple blind (participant, care provider, investigator)
Number of arms: 2

Arm	Type	Receives
Iopamiro-370	Active comparator	Drug: Iopamidol injection 76%
Visipaque 320	Active comparator	Drug: iodixanol

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (8 listed)

Provides written Informed Consent and is willing to comply with protocol requirements
Is >18 years of age
Has a documented predose serum creatinine level of ≥1.5 mg/dL for men and ≥1.3 mg/dL for women or predose eGFR of >15 and ≤50 mL/min/1.73 m2, calculated via the Modification of Diet in Renal Disease (MDRD) formula from a SCr obtained within 72 hours of enrollment into the study;
Diagnosed as having diabetes mellitus (Type 1 or Type 2) treated with insulin or oral hypoglycemic agents for at least 6 months
Is referred for cardiac angiography with or without percutaneous coronary intervention;

Key exclusion criteria (15 listed)

-Is a pregnant or lactating female. Exclude the possibility of pregnancy: by laboratory testing on-site at the institution (measurement of serum or urine beta human chorionic gonadotropin) within 24 hours prior to the start of investigational product administration by history (e.g., tubal ligation or hysterectomy, post menopausal with a minimum 1 year without menses)
Has a history of hypersensitivity to iodine-containing compounds;
Has unstable renal function (i.e., acute worsening of renal function, as determined by the Investigator, that has been observed in the 7 days prior to enrollment) and/or is in acute renal failure;
Has stage 5 chronic kidney disease or end-stage renal disease (i.e., estimated glomerular filtration rate [eGFR] <15 mL/min/1.73 m2)
Has severe congestive heart failure (class IV in accordance with the classification of the New York Heart Association (NYHA);

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 injection 76%Also: IsovueIopamiro-370 (Iopamidol injection 76%) is provided in single dose bottles/vials, ready to use, aqueous, nonpyrogenic, colorless to pale yellow sterile solution	Drug	Iopamiro-370
iodixanolVisipaque 320 (iodixanol) injection is provided in bottles/flexible containers, ready to use sterile, pyrogen-free colorless to pale yellow solution	Drug	Visipaque 320

Primary outcome

The Number of Participants With Contrast-induced Nephropathy (CIN)
Time frame: 48 to 72 hours After Injection of Contrast Media
The number of participants who presented with CIN (defined as an increase in Serum Creatinine (SCr) from baseline greater than or equal to 0.5 mg/dL following the administration of iopamidol-370 or iodixanol 320 while undergoing cardiac angiography). Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.
Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit
Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
Only 1 participant presented with incidence of CIN (change from baseline greater than or equal to 0.5 mg/dL) following the administration of iopamidol-370 while undergoing cardiac angiography. The participant's measurements at baseline and at 48 to 72 hours after the injection of contrast agent, as well as the difference between the two, are displayed here. Since CIN is a prospectively-defined outcome measure of the trial, patients experiencing CIN were not reported as having an adverse event.

4 secondary outcomes

The Number of Participants With a >=25% Decrease in Estimated Glomerular Filtration Rate (eGFR)
Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
The Number of Participants With a >=25% Increase in Serum Creatinine (SCr)
Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media
Number of Participants Requiring Dialysis
Time frame: 48 to 72 hours after injection of contrast media
Number of Participants Who Died From Acute Renal Failure
Time frame: Any timepoint (Screening [up to 72 hours prior to injection of contrast media], Baseline [just before injection], or 48 to 72 hours or 7 days after injection)

Results and safety

Results posted to the registry on 1 Sep 2011, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Iopamiro-370	12	12
Visipaque 320	11	11

Primary outcome: The Number of Participants With Contrast-induced Nephropathy (CIN)

Time frame: 48 to 72 hours After Injection of Contrast Media. Number. Unit: Participants

Measure	Iopamiro-370 n = 12	Visipaque 320 n = 11
Value	1	0

Primary outcome: Baseline and Change From Baseline Measurements for the One Participant With Contrast-Induced Nephropathy (CIN) at the 48 to 72 Hours After Injection of Contrast Media Visit

Time frame: Baseline (just prior to injection of contrast media) and 48 to 72 hours after injection of contrast media. Number. Unit: milligrams per deciliter (mg/dL)

Measure	Iopamiro-370 n = 1	Visipaque 320 n = 0
Baseline	1.10	–
48 to 72 hours After Injection of Contrast Media	1.60	–
Change from Baseline	0.50	–

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Subjects were monitored for any untoward medical occurrences ("adverse events") from the time of signed informed consent and enrollment into the study ("Screening") through 2 hours after the last injection of contrast media.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Iopamiro-370	0 of 12 (0%)	0 of 12 (0%)	Not reported
Visipaque 320	0 of 11 (0%)	0 of 11 (0%)	Not reported

Limitations and caveats (from the sponsor): This study was terminated early due to low enrollment. Only 1 patient in the Iopamiro-370 group had CIN (per all 3 definitions \[first 3 secondary outcome measures\] of CIN); therefore, no formal analyses were performed.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 26 Jan 2012.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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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.

Alberto Spinazzi, M.D. study chair

Bracco Diagnostics

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 injection 76% and iodixanol in people with Chronic Renal Impairment and Diabetes Mellitus, run by Bracco Diagnostics, Inc 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 8 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: stopped early, as of the sponsor's last update on 26 Jan 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 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 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 1 Sep 2011). 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?

The Number of Participants With Contrast-induced Nephropathy (CIN) (time frame: 48 to 72 hours After Injection of Contrast Media). The study lists 2 primary outcomes in all. 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 NCT00782639.

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 26 Jan 2012.