Contrast-Induced Acute Kidney InjuryPhase 2NCT01146925
Deferiprone for the Prevention of Contrast-Induced Acute Kidney Injury
A Phase 2 study testing CRMD-001-Deferiprone in people with Contrast-Induced Acute Kidney Injury, run by CorMedix Therapeutics at 8 sites in United States.
Trial summary
The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Contrast-Induced Acute Kidney Injury
- What is being tested?
- CRMD-001-Deferiprone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 60 participants
- Where
- 8 sitesUnited States
- Study dates
- Jun 2010to Jun 2011
- Phase
- Phase 2
- 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
- Age 18 or older
- eGFR of < 60 ml/min/1.73 m2
- Presence of at least one additional risk factor:
- Diabetes Mellitus
- Age ≥ 75 years
- Left Ventricular Ejection Fraction ≤ 40%
Who cannot join
- End-Stage Renal Disease
- Recent change in serum creatinine
- Primary PCI for STEMI
- Currently receiving mechanical ventilation
- Severe heart failure of cardiogenic shock
- Requirement for inotropic support (prior 30 days)
Show all 12Show fewer
- Sustained hypertension > or = 200/110
- Subject not expected to live for 90 days
- Anticipated use of ioxaglate or iohexol
- Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, N-acetyl cysteine or Ascorbic acid
- Absolute neutrophil count < 1500
- Hemoglobin < 8 gm/dL
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Ohio Health Research Institute
Columbus, Ohio, 43214
St. John Hospital and Medical Center
Detroit, Michigan, 48236
Cardiovascular Catheterization Labs at Fairfield
Fairfield, Ohio, 45104
The Care Group, St. Vincent's Hospital
Indianapolis, Indiana, 46290
Oklahoma Cardiovascular Research Group
Oklahoma City, Oklahoma, 73120
Cardiac and Vascular Research Center of Northern Michigan
Petoskey, Michigan, 49770
Providence Hospital
Southfield, Michigan, 48075
St. Vincent Mercy Medical Center
Toledo, Ohio, 43608
About this study
Official title: A Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury
The primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.
Read the detailed description
This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.
- Conditions
- Contrast-Induced Acute Kidney Injury
- Being tested
- CRMD-001-Deferiprone, Placebo
- Keywords
- Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone
- 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.
CRMD-001-DeferiproneDrug
CRMD-001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days
PlaceboDrug
3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
| Study group | Role | What they receive |
|---|---|---|
| CRMD-001-Deferiprone | Experimental | Not described Receives: Drug: CRMD-001-Deferiprone |
| Placebo | Placebo comparator | Not described Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Biomarker evidence of Acute Kidney injury
Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure
Measured: 8 Days
Secondary outcomes (1)
Incidence of Acute Kidney Injury
Incidence of AKI defined as an absolute increase in serum Cr of ≥ 0.3 mg/dL, and/or a 50% relative increase in serum Cr from baseline (Day 1) to a maximum value obtained within 48 hours of contrast exposure
Measured: 48 hours
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Jun 2010 (estimated)
- Study startJun 2010
- Primary completionJun 2011
- Study completionJun 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- CorMedix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Investigators
- Peter A. McCullough, MD, MPH, Principal investigator, St. John Providence Health System, Novi, MI
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01146925
- Sponsor's protocol ID
- CRMD-001-2001
- Status last verified
- Jun 2011
- First submitted
- 16 Jun 2010
- Last updated
- 27 Jun 2011
- Results posted
- No
- Data monitoring committee
- No
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 Phase II, Randomized, Double-Blind, Placebo-Controlled Trial to Assess the Efficacy and Safety of CRMD-001 in Contrast-Induced Acute Oxidative Kidney Injury
- ClinicalTrials.gov ID
- NCT01146925
- Acronym / sponsor ID
- CRMD-001-2001
- Conditions
- Contrast-Induced Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- CorMedix TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jun 2010
- Primary completion
- Jun 2011 (actual)
- Study completion
- Jun 2011 (actual)
- First posted
- 22 Jun 2010 (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 primary objective of this trial is to assess the impact of CRMD-001 on markers of contrast-induced acute kidney injury (AKI) in high-risk patients with chronic kidney disease (CKD) undergoing coronary angiography and PCI.
Detailed description
This trial will evaluate whether treatment with CRMD-001 (unique formulations of the iron chelator, Deferiprone) will reduce the incidence of AKI in subjects with CKD and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing coronary angiography and PCI will be randomized to either placebo or CRMD-001 and followed for 90 days. Subjects will receive 8 days of randomized therapy starting 1-3 hours prior to angiography. The primary endpoint of the trial will be the difference in mean paired change of a panel of sensitive renal biomarkers between the groups. Differences in renal or cardiovascular clinical events will also be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| CRMD-001-Deferiprone | Experimental | Drug: CRMD-001-Deferiprone |
| Placebo | Placebo comparator | Drug: Placebo |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- Age 18 or older
- eGFR of < 60 ml/min/1.73 m2
- Presence of at least one additional risk factor:
Key exclusion criteria (12 listed)
- End-Stage Renal Disease
- Recent change in serum creatinine
- Primary PCI for STEMI
- Currently receiving mechanical ventilation
- Severe heart failure of cardiogenic shock
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 |
|---|---|---|
| CRMD-001-DeferiproneCRMD-001 represents unique formulations of Deferiprone. Subjects will be given one (900 mg) immediate release and two (900 mg) extended release tablets 1-3 hours prior to angiography and then every 12 hours for a total of 8 days | Drug | CRMD-001-Deferiprone |
| Placebo3 placebo tablets will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography | Drug | Placebo |
Primary outcome
Biomarker evidence of Acute Kidney injury
Time frame: 8 Days
Mean paired change in a panel of acute kidney injury (AKI) biomarkers (urinary NGAL, LFABP, interleukin-18 (IL-18), kidney injury molecule-1 (KIM-1), urinary alpha GST (proximal tubular injury), Pi GST (distal tubular injury) and cystatin C; serum cystatin C) from baseline (Day 1) to peak in the deferiprone and placebo treatment groups, within 192 hours of contrast exposure
1 secondary outcome
Incidence of Acute Kidney Injury
Time frame: 48 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 27 Jun 2011.
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Contrast-induced Acute Kidney Injury (CI-AKI) Following Coronary Angiogram (CI-AKI), Contrast-induced Nephropathy Following Coronary Angiogram (CIN)
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Uric Acid to Albumin Ratio for Predicting Contrast Associated Acute Kidney Injury After Cardiac and Non Cardiac Procedures
Contrast-Induced Nephropathy, Acute Kidney Injury
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Beyond the Mehran Risk Score: Predictive Value of Total Ischemic Time for Contrast-Induced Nephropathy in ST Segment Elevation Myocardial Infarction Patients Undergoing Primary Percutaneous Coronary Intervention.
ST Elevation (STEMI) Myocardial Infarction, Contrast Induced Nephropathy (CIN)
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Contrast Volume as a Predictor of Kidney Injury Following Contrast-Enhanced CT
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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.
Peter A. McCullough, MD, MPH principal investigator
St. John Providence Health System, Novi, MI
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing CRMD-001-Deferiprone in people with Contrast-Induced Acute Kidney Injury, run by CorMedix Therapeutics at 8 sites 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 6 inclusion and 12 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 8 sites 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. 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 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?
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?
Biomarker evidence of Acute Kidney injury (time frame: 8 Days). 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 27 Jun 2011.