Acute Kidney InjuryPhase 3NCT01391520
Efficacy and Safety of Deferiprone in Patients With Chronic Kidney Disease Undergoing a Cardiac Catheterization and Receiving Contrast Agent
A Phase 3 study testing deferiprone in people with Acute Kidney Injury, run by CorMedix Therapeutics.
Trial summary
This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- deferiprone
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 0 participants
- Where
- No sites listed yet
- Study dates
- Jan 2012to Jun 2013
- Phase
- Phase 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 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18 or older
- eGFR between 15 ml/min/1.73 m2 and < 60 ml/min/1.73 m2
- Presence of at least one additional risk factor:
- Diabetes Mellitus type 1 or 2
- Age ≥ 75 years
- Left Ventricular Ejection Fraction ≤ 40%
Who cannot join
- End-Stage Renal Disease
- Primary PCI for STEMI
- Currently receiving mechanical ventilation
- Known active liver disease or liver failure
- Evidence of hemodynamic instability, such as a requirement for pressor agents
- Exposure to contrast media within prior 10 days
- Currently receiving fenoldopam, dopamine, theophylline, aminophylline, mannitol, or Ascorbic acid (> 2 g/day)
- Absolute neutrophil count < 1500
About this study
Official title: A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent
This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 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 a composite of specified renal and cardiovascular clinical events occurring through Day 90.
- Conditions
- Acute Kidney Injury
- Being tested
- 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.
deferiproneDrug
3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography
PlaceboDrug
3 tablets (treatment arm assigned in double-blind, randomized manner) 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 |
|---|---|---|
| CRMD001-Deferiprone | Experimental | CRMD001 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 Receives: Drug: deferiprone |
| Placebo | Placebo comparator | 3 placebo tablets matching the appearance of the experimental treatment arm (CRMD001) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
A composite of renal and cardiovascular clinical events occurring through Day 90
Measured: Day 90 following index cardiac catheterization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jul 2011 (estimated)
- Study startJan 2012 (estimated)
- Primary completionMar 2013 (estimated)
- Study completionJun 2013 (estimated)
Why it stopped: Sponsor encountered funding issues for this study.
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 0 participants (actual)
Sponsor and investigators
- Lead sponsor
- CorMedix Therapeutics
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01391520
- Sponsor's protocol ID
- CRMD001-3001
- Status last verified
- Aug 2020
- First submitted
- 7 Jul 2011
- Last updated
- 24 Aug 2020
- Results posted
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Aug 2020. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase III, Randomized, Double-Blind, Placebo-Controlled, Multicenter Study to Assess the Efficacy and Safety of Deferiprone in the Reduction of Morbidity and Mortality in Patients With Chronic Kidney Disease Undergoing Diagnostic or Interventional Cardiac Procedures and Receiving an Iodinated Radiocontrast Agent
- ClinicalTrials.gov ID
- NCT01391520
- Acronym / sponsor ID
- CRMD001-3001
- Conditions
- Acute Kidney Injury
- Keywords
- Acute Kidney Injury, Contrast-Induced Nephropathy, Labile Iron, Iron Chelation, Deferiprone
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- WithdrawnReason stopped: Sponsor encountered funding issues for this study.
- Enrolment
- 0 participants (actual)
- Lead sponsor
- CorMedix TherapeuticsIndustry (pharma, biotech, devices)
- Study start
- Jan 2012 (estimated)
- Primary completion
- Mar 2013 (estimated)
- Study completion
- Jun 2013 (estimated)
- First posted
- 12 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.
This trial will evaluate whether treatment with CRMD001 (unique formulations of the iron chelator, Deferiprone) will reduce morbidity and mortality in subjects with Chronic Kidney Disease (CKD) and additional risk factors. Adult subjects with moderate to severe CKD who are undergoing diagnostic or interventional coronary angiography will be randomized to either placebo or CRMD001 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 a composite of specified renal and cardiovascular clinical events occurring through Day 90.
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 |
|---|---|---|
| CRMD001-Deferiprone | Experimental | Drug: deferiproneCRMD001 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 |
| Placebo | Placebo comparator | Drug: Placebo3 placebo tablets matching the appearance of the experimental treatment arm (CRMD001) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography |
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 between 15 ml/min/1.73 m2 and < 60 ml/min/1.73 m2
- Presence of at least one additional risk factor:
Key exclusion criteria (8 listed)
- End-Stage Renal Disease
- Primary PCI for STEMI
- Currently receiving mechanical ventilation
- Known active liver disease or liver failure
- Evidence of hemodynamic instability, such as a requirement for pressor agents
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 |
|---|---|---|
| deferiprone3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography | Drug | CRMD001-Deferiprone |
| Placebo3 tablets (treatment arm assigned in double-blind, randomized manner) will be given every 12 hours for a total of 8 days, beginning 1-3 hours prior to angiography | Drug | Placebo |
Primary outcome
A composite of renal and cardiovascular clinical events occurring through Day 90
Time frame: Day 90 following index cardiac catheterization
Results and safety
The study was withdrawn before enrolling participants, so there are no results.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Aug 2020.
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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.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing deferiprone in people with Acute Kidney Injury, run by CorMedix Therapeutics.
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 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: withdrawn, as of the sponsor's last update on 24 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.
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 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 was withdrawn before enrolling participants, so there are no results.
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?
A composite of renal and cardiovascular clinical events occurring through Day 90 (time frame: Day 90 following index cardiac catheterization). 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 24 Aug 2020.