Chronic Renal DiseasePhase 4NEIHRNCT01402219
Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients
A Phase 4 study testing Iopamidol injection 76% and iodixanol in people with Chronic Renal Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
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 chronic kidney disease undergoing coronary angiography. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Chronic Renal Disease
- 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
- 204 participants
- Where
- 1 siteChina
- Study dates
- Nov 2008to May 2013
- Phase
- Phase 4
- 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
- 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 estimated glomerular filtration rate (eGFR) of > 15 and ≤ 60 mL/min/1.73 m2, calculated via the MDRD formula from a SCr obtained within 72 hours of enrollment into the study;
- Is referred for cardiac angiography with or without PCI;
- 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 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 24 hours after cardiac angiography,for the patients with left ventricular ejection fraction <35% or congestive heart failure (class III in accordance with the classification of the New York Heart Association (NYHA), the rate of infusion decreases to half of the above ordinary rate.
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 βHCG) 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 end-stage renal disease (i.e., 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;
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- 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; intake of nephrotoxic drugs within the previous seven days 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.);
- Is planned to undergo major surgery (e.g. CABG, 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
Trial locations and contacts
1 site in 1 country.
China1 site
Guangdong Cardiovascular Institute,Guangdong General Hospital
Guangzhou, Guangdong, 510100
About this study
Official title: Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients:A Multicentre Randomized Double-Blind Trail of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease
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 chronic kidney disease undergoing coronary angiography.
Read the detailed description
To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.
- Conditions
- Chronic Renal Disease
- Being tested
- Iopamidol injection 76%, iodixanol
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, coronary angiography, chronic kidney disease
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopamidol injection 76%Drug
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 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.
contrast-induced nephropathy
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure
Measured: 48-72 h
Secondary outcomes (7)
A relative increase in serum creatinine
A relative increase in serum creatinine was defined as more than 25% increase in serum creatinine within 48-72 h of contrast exposure.
Measured: 48-72 h
A relative increase in estimated glomerular filtration rate (eGFR)
A relative increase in eGFR was defined as more than 25% increase in eGFR within 48-72 h of contrast exposure
Measured: 48-72 h
An absolute increase in serum creatinine
An absolute increase in serum creatinine within 48-72 h of contrast exposure
Measured: 48-72 h
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, 2nd myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Measured: 1 month
Major adverse clinical events
Major adverse clinical events: death, requiring renal replacement therapy, acute myocardial infarction,target revascularization,acute heart failure, mechanical ventilation,2nd angina,tachyarrhythmia,hypotension,intra-aortic balloon pump and stroke
Measured: 1 year
An significant increase in serum creatinine
An significant increase in serum creatinine was defined as an increase in serum creatinine of more than 1.0 mg/dl from the baseline within 48-72 h of contrast exposure
Measured: 48-72 h
Contrast-Induced Acute Kidney Injury
Contrast-Induced Acute Kidney Injury was defined as an increase in serum creatinine concentration of more than 0.3 mg/dL from the baseline value at 48 hours after administration of the contrast exposure or the need for dialysis
Measured: 48 h
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Jul 2011 (estimated)
- Study startNov 2008
- Primary completionFeb 2013
- Study completionMay 2013
Why it stopped: There were few eligible subjects from other centers.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Renal DiseaseStudies of the same condition, open and under way.
- More trials run by Guangdong Provincial People's 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 4
- Primary purpose
- Diagnosis
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Triple blind
- Who is masked
- Participant, Care provider, Investigator
- Enrolment
- 204 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command
- Responsible party
- Principal investigator, Jiyan Chen, Guangdong Provincial People's Hospital
- Investigators
- Jiyan Chen, MD, Study chair, chen-jiyan@163.comYingling Zhou, MD, Study director, Guangdong Cardiovascular Institute,Guangdong General HospitalYong Liu, MD, Principal investigator, liuyongyisheng@126.com
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01402219
- Sponsor's protocol ID
- 2008A030201002
- Acronym
- NEIHR
- Status last verified
- Aug 2013
- First submitted
- 25 Jul 2011
- Last updated
- 28 Aug 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 28 Aug 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Nephrotoxicity of Iopamidol Versus Iodixanol in High-Risk Patients:A Multicentre Randomized Double-Blind Trail of Contrast-Induced Nephropathy in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01402219
- Acronym / sponsor ID
- NEIHR / 2008A030201002
- Conditions
- Chronic Renal Disease
- Keywords
- contrast-induced nephropathy, contrast medium, creatinine clearance, coronary angiography, chronic kidney disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: There were few eligible subjects from other centers.
- Enrolment
- 204 participants (actual)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Collaborators
- First Affiliated Hospital, Sun Yat-Sen University, Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University, Nanfang Hospital, Southern Medical University, Guangzhou General Hospital of Guangzhou Military Command
- Study start
- Nov 2008
- Primary completion
- Feb 2013 (actual)
- Study completion
- May 2013 (actual)
- First posted
- 26 Jul 2011 (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 compare the incidence of contrast-induced nephropathy (CIN) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease undergoing coronary angiography.
Detailed description
To compare the incidence of contrast-induced nephropathy (CIN)(an absolute SCr increase 0.5 mg/dL from baseline) following the administration of iopamidol-370 (Iopamiro-370) and iodixanol-320 (Visipaque 320) in patients with chronic kidney disease (serum creatinine level more than 1.5 mg/dL for men and more than 1.3 mg/dL for women or preprocedural estimated glomerular filtration rate(eGFR):15-60 mL/min/1.73 m2) undergoing coronary angiography.
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 (7 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 estimated glomerular filtration rate (eGFR) of > 15 and ≤ 60 mL/min/1.73 m2, calculated via the MDRD formula from a SCr obtained within 72 hours of enrollment into the study;
- Is referred for cardiac angiography with or without PCI;
- 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);
Key exclusion criteria (10 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 βHCG) 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 end-stage renal disease (i.e., 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%Iopamiro-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
contrast-induced nephropathy
Time frame: 48-72 h
Contrast-Induced Nephropathy was defined as an increase in serum creatinine of more than 0.5 mg/dl or 25% from the baseline within 48-72 h of contrast exposure
7 secondary outcomes
A relative increase in serum creatinine
Time frame: 48-72 h
A relative increase in estimated glomerular filtration rate (eGFR)
Time frame: 48-72 h
An absolute increase in serum creatinine
Time frame: 48-72 h
Major adverse clinical events
Time frame: 1 month
Major adverse clinical events
Time frame: 1 year
An significant increase in serum creatinine
Time frame: 48-72 h
Contrast-Induced Acute Kidney Injury
Time frame: 48 h
Results and safety
The study was stopped early (reason given: There were few eligible subjects from other centers.). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 28 Aug 2013.
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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.
Jiyan Chen, MD study chair
chen-jiyan@163.com
Yingling Zhou, MD study director
Guangdong Cardiovascular Institute,Guangdong General Hospital
Yong Liu, MD principal investigator
liuyongyisheng@126.com
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 Disease, run by Guangdong Provincial People's Hospital at 1 site in China.
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 7 inclusion and 10 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 28 Aug 2013. 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 China. 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?
The study was stopped early (reason given: There were few eligible subjects from other centers.). 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?
contrast-induced nephropathy (time frame: 48-72 h). 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 28 Aug 2013.