Contrast Induced Acute Kidney InjuryEarly Phase 1DrKILDARENCT01908309
Contrast-inDuced nephRotoxicity as Assessed by the KIdney Load-to-DAmage RElationship
A Early Phase 1 study testing Iobitridol 350 and Iodixanol 320 in people with Contrast Induced Acute Kidney Injury, run by Azienda Sanitaria Locale 9, Grosseto at 1 site in Italy.
Trial summary
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Read more about this study
- Who is it for?
- Ages 20 to 90 years
- Conditions the study is for
- Contrast Induced Acute Kidney Injury
- What is being tested?
- Iobitridol 350 and Iodixanol 320
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 150 participants
- Where
- 1 siteItaly
- Study dates
- Apr 2013to Oct 2014
- Phase
- Early Phase 1
- 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 20 to 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients candidate to coronary angiography and/or angioplasty and
- Baseline creatinine clearance < 60 ml/min
Who cannot join
- Patients with STEMI
- Patients with shock
- Known allergy to contrast media
- Prior contrast administration within 1 month
- Current use of nonsteroidal anti-inflammatory drugs
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
Read the detailed description
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
- Conditions
- Contrast Induced Acute Kidney Injury
- Being tested
- Iobitridol 350, Iodixanol 320
- Keywords
- acute kidney injury, contrast media, cystatin-C
- Medical subject headings
- Acute Kidney Injury
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Iobitridol 350Drug
Iodixanol 320Drug
| Study group | Role | What they receive |
|---|---|---|
| Iodixanol | Active comparator | Patients randomized to coronary angiography/angioplasty with Iodixanol 320 Receives: Drug: Iodixanol 320 |
| Iobitridol | Active comparator | Patients randomized to coronary angiography/angioplasty with Iobitridol 350 Receives: Drug: Iobitridol 350 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Slope of LDR (as assessed by serum cystatin-C changes)
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
Measured: 48 hours
Secondary outcomes (1)
Slope of LDR (as assessed by serum creatinine changes)
Slope of the relationship plotting individual iodine loads against serum creatinine changes at 72 hours after catheterization
Measured: 72 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Jul 2013 (estimated)
- Study startApr 2013
- Primary completionOct 2014
- Study completionOct 2014
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 Contrast Induced Acute Kidney InjuryStudies 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
- Early Phase 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 150 participants (actual)
Sponsor and investigators
- Lead sponsor
- Azienda Sanitaria Locale 9, Grosseto
- Sponsor type
- Other government
- Responsible party
- Principal investigator, Ugo Limbruno, Azienda Sanitaria Locale 9, Grosseto
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01908309
- Sponsor's protocol ID
- K-3
- Acronym
- DrKILDARE
- Status last verified
- Jun 2015
- First submitted
- 23 Jul 2013
- Last updated
- 23 Jun 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56.
PubMed 23811842
Study at a glance
From the registry record, last updated by the sponsor on 23 Jun 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Contrast-inDuced nephRotoxicity as Assessed by the Cystatin-modified KIdney Load-to-DAmage RElationship
- ClinicalTrials.gov ID
- NCT01908309
- Acronym / sponsor ID
- DrKILDARE / K-3
- Conditions
- Contrast Induced Acute Kidney Injury
- Keywords
- acute kidney injury, contrast media, cystatin-C
- Phase
- Early Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 150 participants (actual)
- Lead sponsor
- Azienda Sanitaria Locale 9, GrossetoOther government
- Study start
- Apr 2013
- Primary completion
- Oct 2014 (actual)
- Study completion
- Oct 2014 (actual)
- First posted
- 25 Jul 2013 (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.
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast. Aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
Detailed description
We previously demonstrated that the slope of the relationship plotting individual iodine loads against contrast-induced serum creatinine changes ( the load-to-damage relationship, LDR) characterizes the intrinsic nephrotoxicity of the contrast and it may allow for reliable comparative evaluations among small sized study groups randomized to different contrast media. The aim of the present study is to compare, through the assessment of the LDR slope, the intrinsic nephrotoxicity of two different contrast media using serum cystatin-C changes as the LDR dependent variable.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Iodixanol | Active comparator | Drug: Iodixanol 320Patients randomized to coronary angiography/angioplasty with Iodixanol 320 |
| Iobitridol | Active comparator | Drug: Iobitridol 350Patients randomized to coronary angiography/angioplasty with Iobitridol 350 |
Who may qualify
- Ages
- 20 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- Patients candidate to coronary angiography and/or angioplasty and
- Baseline creatinine clearance < 60 ml/min
Key exclusion criteria (5 listed)
- Patients with STEMI
- Patients with shock
- Known allergy to contrast media
- Prior contrast administration within 1 month
- Current use of nonsteroidal anti-inflammatory drugs
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 |
|---|---|---|
| Iobitridol 350 | Drug | Iobitridol |
| Iodixanol 320 | Drug | Iodixanol |
Primary outcome
Slope of LDR (as assessed by serum cystatin-C changes)
Time frame: 48 hours
Slope of the relationship plotting individual iodine loads against serum cystatin-C changes at 48 hours after catheterization
1 secondary outcome
Slope of LDR (as assessed by serum creatinine changes)
Time frame: 72 hours
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 23 Jun 2015.
- Background: PubMed 23811842Limbruno U, Picchi A, Micheli A, Calabria P, Cortese B, Brizi G, Severi S, De Caterina R. Refining the assessment of contrast-induced acute kidney injury: the load-to-damage relationship. J Cardiovasc Med (Hagerstown). 2014 Jul;15(7):587-94. doi: 10.2459/JCM.0b013e3283638e56.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Early Phase 1 study testing Iobitridol 350 and Iodixanol 320 in people with Contrast Induced Acute Kidney Injury, run by Azienda Sanitaria Locale 9, Grosseto at 1 site in Italy.
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 2 inclusion and 5 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 23 Jun 2015. 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 Italy. 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?
Early Phase 1 (sometimes called Phase 0) studies give a very small amount of a treatment to a few people, mainly to see how the body handles it.
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?
Slope of LDR (as assessed by serum cystatin-C changes) (time frame: 48 hours). 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 NCT01908309, 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 23 Jun 2015.