Chronic Renal InsufficiencyPhase 2NCT01252810
Safety Study of GE-145 320 mg I/mL Injection vs. Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Procedure
A Phase 2 study testing GE-145 in people with Chronic Renal Insufficiency and Diabete Mellitus, run by GE Healthcare at 1 site in United States.
Trial summary
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater… Read more about this study
- Who is it for?
- Ages 65 years and older
- Conditions the study is for
- Chronic Renal Insufficiency, Diabete Mellitus, Congestive Heart Failure
- What is being tested?
- GE-145
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 284 participants
- Where
- 1 siteUnited States
- Study dates
- Nov 2010to Dec 2012
- Phase
- Phase 2
- 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 65 years and older
- All sexes
- No healthy volunteers
- Older adult
Who may be able to join
- Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- The subject has at least one of the following comorbidities:
- 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Who cannot join
- The subject has known allergies to either iodine or any ICM.
- The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
- Being tested
- GE-145
- Keywords
- CATH Catheterization, CI-AKI Contrast-induced acute kidney injury, DM Diabetes mellitus, eGFR Estimated glomerular filtration rate, MDRD Modification of Diet in Renal Disease, NYHA New York Heart Association, PCI Percutaneous coronary intervention, SCr Serum creatinine
- Medical subject headings
- Renal Insufficiency, Chronic, Diabetes Mellitus, Heart Failure
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GE-145Drug
Also called Ioforminol
GE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration.
| Study group | Role | What they receive |
|---|---|---|
| GE 145 320mg I/ml injection | Experimental | Not described Receives: Drug: GE-145 |
| Iopamidol 370mg I/ml injection | Active comparator | Not described Receives: Drug: GE-145 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
Measured: After the imaging date for either Ioforminol or Iopamidol.
Secondary outcomes (2)
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
To determine incidence rates of the overall AEs, organ-specific AEs (i.e., delayed skin reactions, general subject comfort, and allergic/immunologic reactions, etc.) and SAEs following administration of GE-145 or iopamidol.
To determine incidence rates and onset time of biomarker-based and SCr-based CI-AKI following administration of GE-145 or iopamidol.
Summary of Treatment-Emergent Adverse Events (TEAE) in greater than of equal to 2% of Subjects.
Measured: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
Analyzing the number of subjects with renal biomarker-based contrast-induced acute kidney injury (CI-AKI).
Measured: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2010 (estimated)
- Study startNov 2010
- Primary completionDec 2012
- Study completionDec 2012
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 InsufficiencyStudies of the same condition, open and under way.
- More trials run by GE HealthcareThe 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
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 284 participants (actual)
Sponsor and investigators
- Lead sponsor
- GE Healthcare
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- i3 Statprobe, Medpace, Inc., Biomedical Systems, Rules-Based Medicine, Inc.
- Responsible party
- Sponsor
- Investigators
- Rubin Sheng, M.D., Study director, GE Healthcare
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01252810
- Sponsor's protocol ID
- GE 145-002
- Status last verified
- Aug 2018
- First submitted
- 1 Dec 2010
- Last updated
- 29 Aug 2018
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 29 Aug 2018. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Double-Blind, Randomized, Safety Study of GE-145 320 mg I/mL Injection Versus Iopamidol 370 mg I/mL in Elderly Subjects Undergoing Coronary Artery Catheterization Procedure
- ClinicalTrials.gov ID
- NCT01252810
- Acronym / sponsor ID
- GE 145-002
- Keywords
- CATH Catheterization, CI-AKI Contrast-induced acute kidney injury, DM Diabetes mellitus, eGFR Estimated glomerular filtration rate, MDRD Modification of Diet in Renal Disease, NYHA New York Heart Association, PCI Percutaneous coronary intervention, SCr Serum creatinine
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 284 participants (actual)
- Lead sponsor
- GE HealthcareIndustry (pharma, biotech, devices)
- Collaborators
- i3 Statprobe, Medpace, Inc., Biomedical Systems, Rules-Based Medicine, Inc.
- Study start
- Nov 2010
- Primary completion
- Dec 2012 (actual)
- Study completion
- Dec 2012 (actual)
- First posted
- 3 Dec 2010 (estimated)
- Results
- Posted 2 May 2014
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
To evaluate cardio-renal and overall safety profile of GE 145 320 mg I/ml Injection when compared to iopamidol 370 mg I/mL. The study will focus on elderly subjects with either chronic renal insufficiency, or diabetes mellitus (DM) requiring drug therapy, or congestive heart failure (CHF) NYHA Class III or greater, who are referred for a coronary catheterization procedure with or without PCI.
Study design
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GE 145 320mg I/ml injection | Experimental | Drug: GE-145 |
| Iopamidol 370mg I/ml injection | Active comparator | Drug: GE-145 |
Who may qualify
- Ages
- 65 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Older adult
Key inclusion criteria (5 listed)
- Males and females 65 years of age with cardiovascular disease who are referred for a coronary catheterization procedure with or without PCI.
- The subject has at least one of the following comorbidities:
- 1) Chronic renal insufficiency, (eGFR <60 but 15 mL/min/1.73 m2 according to the MDRD equation) as measured within 2 weeks or at the screening visit;
- 2) DM diagnosed greater than 6 months prior to study entry and which requires either insulin or anti-hyperglycemic drug therapy;
- 3) CHF (NYHA) class III or greater measured within 2 weeks of enrollment or at the screening visit.
Key exclusion criteria (4 listed)
- The subject has known allergies to either iodine or any ICM.
- The subject has severe renal insufficiency (eGFR <15 mL/min/1.73 m2 according to the MDRD equation) or is on dialysis.
- The subject has acute coronary syndrome requiring emergency coronary angiography and/or intervention.
- The subject is not willing or unable to discontinue metformin (e.g., Glucophage) at the time of the study procedure.
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 |
|---|---|---|
| GE-145Also: IoforminolGE-145-320 mg I/mL as a single iv. administration. Comparator agent Isovue (iopamidol) 370 mg I/mL as a single iv. administration. | Drug | GE 145 320mg I/ml injection, Iopamidol 370mg I/ml injection |
Primary outcome
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader.
Time frame: After the imaging date for either Ioforminol or Iopamidol.
Overall image quality (excellent, adequate or poor) and diagnostic usefulness (diagnostic or non-diagnostic) were assessed using qualitative scales.
2 secondary outcomes
To Determine Incidence Rates of the Overall AEs, Organ-specific AEs (i.e., Delayed Skin Reactions, General Subject Comfort, and Allergic/Immunologic Reactions, Etc.) and SAEs Following Administration
Time frame: Time zero equals the date of contrast imaging and for up to 7 days for safety monitoring post contrast administration.
Assessing the Incidence of Renal Biomarker-based Contrast-induced Acute Kidney Injury (CI-AKI) in Subjects Post Administration of Ioforminol or Iopamidol Injections
Time frame: 2, 6 and 24 hours post Ioforminol and Iopamidol adminstration
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 29 Aug 2018.
- 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.
Rubin Sheng, M.D. study director
GE Healthcare
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GE-145 in people with Chronic Renal Insufficiency and Diabete Mellitus, run by GE Healthcare 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 5 inclusion and 4 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 29 Aug 2018. 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 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?
Yes. Results are posted in the registry (first posted 2 May 2014). 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?
Comparison of Overall Image Quality Between Ioforminol and Iopamidol-enhanced Images as Determined by an Independent Reader. (time frame: After the imaging date for either Ioforminol or Iopamidol.). 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 29 Aug 2018.