Kidney Failure, ChronicPhase 4DIRECTNCT00926562
A Safety Comparison of Iopromide and Iodixanol in Renal Impaired Patients
A Phase 4 study testing Iopromide (Ultravist) and Iodixanol (Visipaque) in people with Kidney Failure, Chronic, run by Chinese PLA General Hospital at 19 sites in China.
Trial summary
The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI). Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure, Chronic
- What is being tested?
- Iopromide (Ultravist) and Iodixanol (Visipaque)
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 592 participants
- Where
- 19 sitesChina
- Study dates
- Feb 2009to May 2011
- 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
- 18 years old or older
- Plan to undergo Cardiac Catheterization
- Signed ICF
- eGFR: 30~59 mL/min/1.73m2
Who cannot join
- Pregnancy
- Under dialysis
- Conditions interfering with Cardiac Catheterization
- Participation in other trials
- Allergic to X-ray contrast media
- Administration of any investigational drug within the previous 30 days
Show all 9Show fewer
- Intra-arterial or intravenous administration of iodinated contrast medium from 7 days before to 72 hours after the administration of study drug
- Left ventricular ejection fraction (LVEF) less than 30% by ultrasound examination
- Intake of any nephrotoxic medications 24 hours before or after the administration of study drug
Trial locations and contacts
19 sites in 1 country.
19 sites in 1 country
China19 sites
Beijing CHAO-YANG Hospital
Beijing, Beijing Municipality, 100020
General Hospital of Armed Police Forces
Beijing, Beijing Municipality, 100039
Peking University Third Hospital
Beijing, Beijing Municipality, 100191
Beijing Shi Jing Shan Hospital
Beijing, Beijing Municipality, 10040
Beijing Hospital
Beijing, Beijing Municipality, 100730
Chinese PLA general hospital
Beijing, Beijing Municipality, 100853
China-Japan Union Hospital of Jilin University
Changchun, Jilin, 130033
The First Hospital of Jilin University
Changchun, Jinlin, 130021
The Second Hospital of Xiangya
Changsha, Hunan, 410013
The Second Hospital Affiliated to Zhejiang University
Hangzhou, Zhejiang, 310009
Sir Run Run Shaw Hospital affiliated to Zhejiang
Hangzhou, Zhejiang, 310016
Shanghai First People's Hospital
Shanghai, Shanghai Municipality, 200080
Renji Hospital affiliated to Shanghai Jiao Tong University
Shanghai, Shanghai Municipality, 200127
Changhai Hospital affiliated to the second millitary medical university
Shanghai, Shanghai Municipality, 200433
Tianjin Chest Hospital
Tianjin, Tianjin Municipality, 300051
Teda International Cardiovascular Hospital
Tianjin, Tianjin Municipality, 300457
Wuhan Asia Heart Hospital
Wuhan, Hubei, 430022
Henan Provincial People's Hospital
Zhengzhou, Henan, 450003
The First Affiliated Hospital of Zhengzhou University
Zhengzhou, Henan, 450052
About this study
Official title: A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
The investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
Read the detailed description
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.
- Conditions
- Kidney Failure, Chronic
- Being tested
- Iopromide (Ultravist), Iodixanol (Visipaque)
- Keywords
- Contrast Induced Nephropathy, CIN, Cardiac Catheterization
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iopromide (Ultravist)Drug
Also called Ultravist
Iopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM
Iodixanol (Visipaque)Drug
Also called Visipaque
Iodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM
| Study group | Role | What they receive |
|---|---|---|
| Iopromide | Experimental | Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation Receives: Drug: Iopromide (Ultravist) |
| Iodixanol | Active comparator | Drug: Visipaque 320 mgl/ml, injection of intra-artery Receives: Drug: Iodixanol (Visipaque) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
Measured: day 3 postreatment
Secondary outcomes (2)
Proportion of patients developing acute renal failure.
Measured: day 30 postreatment
Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%
Measured: days 3
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Jun 2009 (estimated)
- Study startFeb 2009
- Primary completionDec 2010
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Kidney Failure, ChronicStudies of the same condition, open and under way.
- More trials run by Chinese PLA General 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
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 592 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Investigators
- Yundai Chen, MD, Principal investigator, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00926562
- Sponsor's protocol ID
- 14147
- Acronym
- DIRECT
- Status last verified
- Jun 2011
- First submitted
- 19 Jun 2009
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
Publications
Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.
PubMed 23045301
Study at a glance
From the registry record, last updated by the sponsor on 27 Jun 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Randomized, Double-blinded Comparison of Iopromide and Iodixanol in Renally Impaired Patients Undergoing Cardiac Catheterization
- ClinicalTrials.gov ID
- NCT00926562
- Acronym / sponsor ID
- DIRECT / 14147
- Conditions
- Kidney Failure, Chronic
- Keywords
- Contrast Induced Nephropathy, CIN, Cardiac Catheterization
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 592 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2009
- Primary completion
- Dec 2010 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 23 Jun 2009 (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 investigators intend to find out which contrast agent has less kidney toxicity in renal impaired patients undergoing cardiac angiography or percutaneous coronary intervention (PCI).
Detailed description
In the diagnosis and treatment of coronary heart disease, patients should undergo cardiac angiography or percutaneous coronary intervention (PCI). In those procedures, the investigators should use the contrast media, and it may cause kidney toxicity especially in the patients with chronic renal insufficiency.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iopromide | Experimental | Drug: Iopromide (Ultravist)Drug: Ultravist 370 mgl/ml, injection of intra-artery during cardiac interventional operation |
| Iodixanol | Active comparator | Drug: Iodixanol (Visipaque)Drug: Visipaque 320 mgl/ml, injection of intra-artery |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- 18 years old or older
- Plan to undergo Cardiac Catheterization
- Signed ICF
- eGFR: 30~59 mL/min/1.73m2
Key exclusion criteria (9 listed)
- Pregnancy
- Under dialysis
- Conditions interfering with Cardiac Catheterization
- Participation in other trials
- Allergic to X-ray contrast media
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 |
|---|---|---|
| Iopromide (Ultravist)Also: UltravistIopromide (contrast agent), 370 mgl/ml, an nonionic, monomeric, LOCM | Drug | Iopromide |
| Iodixanol (Visipaque)Also: VisipaqueIodixanol (contrast agent) 320 mgl/ml, a nonionic, dimeric, IOCM | Drug | Iodixanol |
Primary outcome
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline.
Time frame: day 3 postreatment
2 secondary outcomes
Proportion of patients developing acute renal failure.
Time frame: day 30 postreatment
Incidence of a postdose SCr increase ≧25%, a postdose SCr increase ≧1mg/dL, a postdose SCr increase ≧0.5mg/dL, a postdose eGFR decrease ≧25%
Time frame: days 3
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 27 Jun 2011.
- Derived from this study: PubMed 23045301Chen Y, Hu S, Liu Y, Zhao R, Wang L, Fu G, He Q, Su X, Zheng Y, Qi X, Liu H, Wang J, Gao W, Wang M, Liu S, Zheng X, He B, Yang P, Zhou S, Gao C, Qiu C. Renal tolerability of iopromide and iodixanol in 562 renally impaired patients undergoing cardiac catheterisation: the DIRECT study. EuroIntervention. 2012 Nov 22;8(7):830-8. doi: 10.4244/EIJV8I7A126.
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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.
Yundai Chen, MD principal investigator
Chinese PLA General Hospital
19 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Iopromide (Ultravist) and Iodixanol (Visipaque) in people with Kidney Failure, Chronic, run by Chinese PLA General Hospital at 19 sites 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 4 inclusion and 9 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 27 Jun 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites 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 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?
Proportion of patients exhibiting a relative increase in serum creatinine >= 50% from baseline. (time frame: day 3 postreatment). 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 NCT00926562, which also lists 1 linked publication.
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 2011.