Renal Insufficiency, ChronicPhase 2/3NCT00345501
Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients Undergoing Coronary Angiography and/or Intervention
A Phase 2/3 study testing Iloprost in people with Renal Insufficiency, Chronic and Coronary Angiography, run by Onassis Cardiac Surgery Centre at 1 site in Greece.
Trial summary
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
- What is being tested?
- Iloprost
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 208 participants
- Where
- 1 siteGreece
- Study dates
- Nov 2005to Jul 2007
- Phase
- Phase 2/3
- 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 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was <60 ml/min on their most recent sample drawn within 1 month of the planned procedure
Who cannot join
- Circulatory shock for any reason, systolic blood pressure <95 mm Hg
- Known acute renal failure
- End-stage renal disease requiring dialysis
- Intravascular administration of a contrast medium within the previous 10 days
- Anticipated re-administration of contrast medium within the following 6 days
- Inability to administer intravenous hydration at least 4 h before the procedure or study medication at least 30 min before the procedure
- Primary intervention for acute infarction with ST elevation
- A procedure performed within 2 h of acute hospital admission
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
The prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.
- Conditions
- Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
- Being tested
- Iloprost, Placebo
- Keywords
- contrast media, contrast nephropathy
- 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.
IloprostDrug
Iloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end
PlaceboDrug
Placebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end
| Study group | Role | What they receive |
|---|---|---|
| 1 | Experimental | Iloprost Receives: Drug: Iloprost |
| 2 | Placebo comparator | Placebo Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
Measured: 2-5 days after the procedure
or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
Measured: blood sample drawn at 2-5 days after the procedure
Secondary outcomes (1)
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
Measured: 2-5 days after the procedure
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted28 Jun 2006 (estimated)
- Study startNov 2005
- Study completionJul 2007
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 Renal Insufficiency, ChronicStudies 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 2/3
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 208 participants (actual)
Sponsor and investigators
- Lead sponsor
- Onassis Cardiac Surgery Centre
- Sponsor type
- University, hospital or other
- Investigators
- Konstantinos Spargias, MD, Principal investigator, Onassis Cardiac Surgery Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00345501
- Sponsor's protocol ID
- OCS IEC 265
- Other IDs
- EudraCT 2005-001887-30
- Status last verified
- Aug 2007
- First submitted
- 27 Jun 2006
- Last updated
- 24 Aug 2007
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Spargias K, Adreanides E, Demerouti E, Gkouziouta A, Manginas A, Pavlides G, Voudris V, Cokkinos DV. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation. 2009 Nov 3;120(18):1793-9. doi: 10.1161/CIRCULATIONAHA.109.863159. Epub 2009 Oct 19.
PubMed 19841299
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2007. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Iloprost for Prevention of Contrast-Mediated Nephropathy in High-Risk Patients With Preexisting Renal Dysfunction Undergoing a Coronary Procedure
- ClinicalTrials.gov ID
- NCT00345501
- Acronym / sponsor ID
- OCS IEC 265
- Conditions
- Renal Insufficiency, Chronic, Coronary Angiography, Angioplasty, Transluminal, Percutaneous Coronary
- Keywords
- contrast media, contrast nephropathy
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 208 participants (actual)
- Lead sponsor
- Onassis Cardiac Surgery CentreUniversity, hospital or other
- Study start
- Nov 2005
- Study completion
- Jul 2007 (actual)
- First posted
- 28 Jun 2006 (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 prevention of contrast-mediated nephropathy (CMN), which accounts for considerable morbidity and mortality, remains a vexing problem. Contrast induced renal vasoconstriction is believed to play a pivotal role in the CMN mechanism. The aim of this study is to examine the efficacy of the prostacyclin analogue iloprost (dose 1ng/kg/min) in preventing CMN in high-risk patients undergoing a coronary procedure.
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 |
|---|---|---|
| 1 | Experimental | Drug: IloprostIloprost |
| 2 | Placebo comparator | Drug: PlaceboPlacebo |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (1 listed)
- Patients undergoing clinically driven, non-emergent coronary angiography or intervention in our institution were eligible for inclusion if their serum creatinine concentration was ≥1.4 mg/dl (124 μmol/l) and/or their creatinine clearance was <60 ml/min on their most recent sample drawn within 1 month of the planned procedure
Key exclusion criteria (8 listed)
- Circulatory shock for any reason, systolic blood pressure <95 mm Hg
- Known acute renal failure
- End-stage renal disease requiring dialysis
- Intravascular administration of a contrast medium within the previous 10 days
- Anticipated re-administration of contrast medium within the following 6 days
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 |
|---|---|---|
| IloprostIloprost 1ng/kg/min IV starting 1 hour before the procedure and continuing for 4 hours after its end | Drug | 1 |
| PlaceboPlacebo IV (Normal saline) starting 1 hour before the procedure and continuing for 4 hours after its end | Drug | 2 |
Primary outcome
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl
Time frame: 2-5 days after the procedure
or CMN is defined as a relative rise of at least 25% from baseline on the follow-up
Time frame: blood sample drawn at 2-5 days after the procedure
1 secondary outcome
Differences in the progression of serum creatinine concentrations and creatinine clearance among the study groups
Time frame: 2-5 days after the procedure
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 24 Aug 2007.
- Derived from this study: PubMed 19841299Spargias K, Adreanides E, Demerouti E, Gkouziouta A, Manginas A, Pavlides G, Voudris V, Cokkinos DV. Iloprost prevents contrast-induced nephropathy in patients with renal dysfunction undergoing coronary angiography or intervention. Circulation. 2009 Nov 3;120(18):1793-9. doi: 10.1161/CIRCULATIONAHA.109.863159. Epub 2009 Oct 19.
- Hospital SiteLink provided by the sponsor.
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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.
Konstantinos Spargias, MD principal investigator
Onassis Cardiac Surgery Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Iloprost in people with Renal Insufficiency, Chronic and Coronary Angiography, run by Onassis Cardiac Surgery Centre at 1 site in Greece.
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 1 inclusion and 8 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 24 Aug 2007. 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 Greece. 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 combined 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.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
CMN is defined as an absolute increase of serum creatinine concentration of at least 0.5 mg/dl (time frame: 2-5 days after the procedure). 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 NCT00345501, 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 24 Aug 2007.