Acute Kidney InjuryPhase 2AKITANCT05126303
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
A Phase 2 study testing RMC-035 in people with Acute Kidney Injury, run by Guard Therapeutics AB at 29 sites in 5 countries.
Trial summary
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Acute Kidney Injury
- What is being tested?
- RMC-035
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 177 participants
- Where
- 29 sitesin 5 countries
- Study dates
- 31 Mar 2022to 12 Jul 2023
- Phase
- Phase 2
- Are there results?
- Yes, posted in the registrySummary in the doctors' view
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 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Institutional Review Board/ International Ethics Committee approved Informed Consent obtained
- Ability to understand and comply with the study requirements and able to provide written informed consent
- Age ≥18 and <85 years
- Estimated glomerular filtration rate (eGFR) is ≥30 mL/min/1.73 m2
- Subject is scheduled for non-emergent coronary artery bypass grafting (CABG) surgery and/or valve surgery and/or ascending aorta aneurysm surgery with use of cardiopulmonary bypass (CPB), and AKI risk factors are present at screening
- Female subject is not of child-bearing potential, or agreeing not to become pregnant
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- Female subject must not be breastfeeding
- Female subject must not donate ova
- Male subject and their female spouse/partner(s) who are of childbearing potential must be using a highly effective form of birth control
- Male subjects must not donate sperm
- Subject agrees not to participate in another interventional study
Who cannot join
- Medical condition that makes the subject unsuitable for study participation
- Scheduled for emergent surgeries (eg, aortic dissection)
- Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries (eg, congenital heart defects)
- Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
- Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices within 24 hours prior to surgery
- Requirement for defibrillator or permanent pacemaker, mechanical ventilation, intraaortic balloon pumping (IABP), LVAD, or other forms of mechanical circulatory support (MCS)
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- Diagnosed with AKI (as defined by KDIGO criteria) within 3 months prior to surgery
- Required cardiopulmonary resuscitation within 14 days prior to cardiac surgery
- Ongoing sepsis or an untreated diagnosed clinically significant infection (viral or bacterial)
- Total bilirubin or alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥ 2 times the upper limit of normal (ULN)
- History of solid organ transplantation
- History of renal replacement therapy (RRT)
- Medical condition which requires active immunosuppressive treatment
- Severe allergic asthma
- Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
- Received an investigational medicinal product within the last 90 days (or within 5 half-lives of the investigational drug, whichever is longer)
- Subject has a known allergy to RMC-035 or one of its constituents, or has previously received RMC-035
Trial locations and contacts
29 sites in 5 countries.
29 sites in 5 countries
United States8 sites
University of Virginia (UVA) Health - University Hospital
Charlottesville, Virginia, 22908
Baylor Scott and White Research Institute - Dallas
Dallas, Texas, 75226
Duke University Hospital
Durham, North Carolina, 27710
Indiana Ohio Heart
Fort Wayne, Indiana, 48604
Bryan Heart
Lincoln, Nebraska, 68506
University of Wisconsin
Madison, Wisconsin, 53706
Aurora Health Care - Aurora St. Luke's Medical Center
Milwaukee, Wisconsin, 53215
Rochester Regional Health - Rochester General Hospital
Rochester, New York, 14621
Germany8 sites
Herz- und Diabeteszentrum Nordrhein-Westfalen (NRW)
Bad Oeynhausen
Universitätsklinikum Köln
Cologne
Herzzentrum Dresden GmbH
Dresden
Westdeutsches Herzzentrum Essen
Essen
Universitätsklinikum Giessen und Marburg - Standort Giessen
Giessen
Universitätsklinikum Halle (Saale)
Halle
Deutsches Herzzentrum München
München
Münster University Hospital
Münster, DE-481 49
Canada6 sites
Hamilton Health Sciences
Hamilton
CHUM
Montreal
MUHC - Royal Victoria Hospital
Montreal
Institut Universitaire de Cardiologie et de Pneumologie de Québec
Québec
St. John Regional Hospital
Saint John
Saint Michael's Hospital
Toronto
Spain5 sites
Hospital Sant Pau
Barcelona
Reina Sofia University Hospital
Córdoba
Hospital de La Princesa
Madrid
Hospital Universitario Central de Asturias
Oviedo
Complejo Hospitalario Universitario de Santiago (CHUS)
Santiago de Compostela
Czechia2 sites
University Hospital Hradec Kralove
Hradec Králové
University Hospital Motol - Charles University Prague
Prague
About this study
Official title: A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.
Read the detailed description
This is a Phase 2, randomized, double-blind, adaptive, parallel group clinical study that will evaluate RMC-035 compared to placebo in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Subjects are randomized in a 1:1 ratio.
- Conditions
- Acute Kidney Injury
- Being tested
- RMC-035, Placebo
- 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.
RMC-035Drug
Also called ROSgard
Concentrate for Solution for Infusion
PlaceboDrug
Concentrate for Solution for Infusion
| Study group | Role | What they receive |
|---|---|---|
| RMC-035 | Experimental | RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration.
Dosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. Receives: Drug: RMC-035 |
| Placebo | Placebo comparator | Identical to RMC-035 arm except that the placebo contains no active ingredient. Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition
Measured: 72 hours
Secondary outcomes (21)
Area Under the Curve (AUC) of Serum Creatinine (SCr)
Time-corrected area under the curve (AUC) of serum creatinine calculated as follows:
The area under the SCr concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed SCr values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x SCr(12h) + 0.5 x SCr(24h) + 1 x SCr(48h) + 1 x SCr(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3
Measured: 72 hours
Duration of AKI
Duration of AKI defined as the number of days meeting the definition of AKI (KDIGO definition) starting within 72 hours after first dose of IMP until resolution
Measured: 90 days
Change in SCr Values Over Time
SCr at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90
Measured: 90 days
Peak Cystatin C Value
Change from baseline of peak cystatin C from baseline to Day 7
Measured: 7 days
AUC of Cystatin C
Time-corrected AUC of cystatin C for Day 1 to Day 4 (72 hours after first dose of IMP) calculated as follows:
The area under the cystatin C concentration versus time curve following drug administration were calculated using timepoints at Day 1 (12 hour), Day 2 (24 hour), Day 3 (48 hour) and Day 4 (72 hour). The individual log-transformed cystatin C values were determined, and the AUC (utilizing planned times) were calculated using the right Riemann sum: AUC = 0.5 x cystatin C(12h) + 0.5 x cystatin C(24h) + 1 x cystatin C(48h) + 1 x cystatin C(72h) The time-corrected AUC (log-scale) was then calculated as AUC/3
Measured: 72 hours
Number of Participants Requiring Renal Replacement Therapy (Dialysis)
Renal replacement therapy (dialysis treatment) required by any participant for any reason
Measured: 7 days
Number of Days Without Need for Dialysis
Number of days that participants were not requiring dialysis
Measured: 90 days
Major Adverse Kidney Event (MAKE) - SCr
MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.
eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr.
Measured: 90 days
AKI Within 72 Hours Based on Cystatin C and UO
AKI based on cystatin C and/or urine output (UO)
Measured: 72 hours
AKI Within 7 Days
AKI based on SCr and/or UO criteria, or cystatin C and/or UO criteria
Measured: 7 days
Persistence of AKI
AKI persistence, defined as an AKI (KDIGO definition) developing within 72 hours after first dose of IMP and with a duration of ≥72 hours
Measured: 7 days
Severity of AKI
AKI severity stage 1, 2 or 3 per KDIGO criteria, with 1 being mildest stage and 3 being most severe stage.
Reference: KDIGO (2012). "Clinical Practice Guideline for Acute Kidney Injury." JOURNAL OF THE INTERNATIONAL SOCIETY OF NEPHROLOGY 2(1).
Measured: 7 days
Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR)
Post-baseline changes in UACR and UPCR at Day 4, Day 30, and Day 90
Measured: 90 days
Pharmacokinetics of RMC-035 (AUC)
AUC(0-24) of RMC-035 concentrations in plasma (Day 3)
Measured: 4 days
Pharmacokinetics of RMC-035 (Cmax)
Cmax of RMC-035 concentrations in plasma Day 3
Measured: 7 days
Presence of Anti-drug Antibodies (ADA)
Presence of ADA at Day 1 (pre-surgery), Day 30, and Day 90; positive samples
Measured: 90 days
Characteristics of ADA (Cross-reactivity)
Characteristics of ADA developed at Day 30 and Day 90 with regards cross-reactivity with endogenous alpha-1-microglobulin (A1M)
Measured: 90 days
Peak SCr Value
Change from baseline of peak SCr from baseline to Day 7
Measured: 7 days
Major Adverse Kidney Event (MAKE) - Cystatin C
MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.
eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using Cystatin C.
Measured: 90 days
Major Adverse Kidney Event (MAKE) - SCr and Cystatin C
MAKE at Day 30 and Day 90, defined as death, any dialysis, or ≥25% reduction of eGFR compared to baseline.
eGFR calculated based on Chronic Kidney Disease Epidemiology Collaboration (CKD-EPI) equation using SCr and Cystatin C.
Measured: 90 days
Change in Serum Cystatin C Values Over Time
Cystatin C measurement in serum at 12, 24, 48, and 72 hours, respectively, and at Day 7/discharge, Day 30 and Day 90
Measured: 90 days
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Nov 2021
- Study start31 Mar 2022
- Primary completion15 Apr 2023
- Study completion12 Jul 2023
Why it stopped: Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
- Publications (2)Papers the sponsor has linked to this study.
- 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 2
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Randomized, double-blind, adaptive, parallel group
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 177 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guard Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Agervald, MD, Study director, Guard TherapeuticsAlexander Zarbock, MD, Principal investigator, Muenster University Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05126303
- Sponsor's protocol ID
- 21-ROS-05
- Acronym
- AKITA
- Status last verified
- May 2024
- First submitted
- 8 Nov 2021
- Last updated
- 16 May 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
Zarbock A, Larsson TE, Noiseux N, Mazer CD, Bohm J, Laflamme M, Matschke K, Burkert J, de Varennes B, Myjavec A, Boning A, Koyner JL, Engelman D, Reusch M, Thielmann M; AKITA investigators. Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial. EClinicalMedicine. 2024 Sep 16;76:102830. doi: 10.1016/j.eclinm.2024.102830. eCollection 2024 Oct.
PubMed 39318788Mazer CD, Siadati-Fini N, Boehm J, Wirth F, Myjavec A, Brown CD, Koyner JL, Boening A, Engelman DT, Larsson TE, Renfurm R, de Varennes B, Noiseux N, Thielmann M, Lamy A, Laflamme M, von Groote T, Ronco C, Zarbock A. Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial). BMJ Open. 2023 Apr 6;13(4):e068363. doi: 10.1136/bmjopen-2022-068363.
PubMed 37024249
Study at a glance
From the registry record, last updated by the sponsor on 16 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2, Randomized, Placebo-Controlled, Double-Blind, Adaptive, Parallel Group Clinical Study to Evaluate the Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
- ClinicalTrials.gov ID
- NCT05126303
- Acronym / sponsor ID
- AKITA / 21-ROS-05
- Conditions
- Acute Kidney Injury
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: Enrollment discontinued following DMC recommendation based on futility with regards to primary endpoint
- Enrolment
- 177 participants (actual)
- Lead sponsor
- Guard Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 31 Mar 2022 (actual)
- Primary completion
- 15 Apr 2023 (actual)
- Study completion
- 12 Jul 2023 (actual)
- First posted
- 19 Nov 2021 (actual)
- Results
- Posted 16 May 2024
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
This study evaluates RMC-035 compared to placebo for the prevention of acute kidney injury (AKI) in subjects who are at high risk for AKI following cardiac surgery. Half of the subjects will receive RMC-035 and the other half will receive placebo.
Detailed description
This is a Phase 2, randomized, double-blind, adaptive, parallel group clinical study that will evaluate RMC-035 compared to placebo in subjects at high risk for acute kidney injury (AKI) following cardiac surgery. Subjects are randomized in a 1:1 ratio.
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
- Model description
- Randomized, double-blind, adaptive, parallel group
| Arm | Type | Receives |
|---|---|---|
| RMC-035 | Experimental | Drug: RMC-035RMC-035 is a concentrate (6.0 mg/mL) for solution for infusion for IV administration. Dosing will be based on renal function at Day -1: Subjects with eGFR ≥60 mL/min/1.73m2 will receive 1.3 mg/kg (per dose) for the first and second dose, followed by 0.65 mg/kg (per dose) for the third, fourth and fifth dose, while subjects with eGFR >30 and <60 mL/min/1.73m2 will receive 0.65 mg/kg (per dose) for all five doses Dosing occurs at time 0 and then after 6, 12, 24 and 48 hours. |
| Placebo | Placebo comparator | Drug: PlaceboIdentical to RMC-035 arm except that the placebo contains no active ingredient. |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (11 listed)
- Institutional Review Board/ International Ethics Committee approved Informed Consent obtained
- Ability to understand and comply with the study requirements and able to provide written informed consent
- Age ≥18 and <85 years
- Estimated glomerular filtration rate (eGFR) is ≥30 mL/min/1.73 m2
- Subject is scheduled for non-emergent coronary artery bypass grafting (CABG) surgery and/or valve surgery and/or ascending aorta aneurysm surgery with use of cardiopulmonary bypass (CPB), and AKI risk factors are present at screening
Key exclusion criteria (17 listed)
- Medical condition that makes the subject unsuitable for study participation
- Scheduled for emergent surgeries (eg, aortic dissection)
- Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries (eg, congenital heart defects)
- Scheduled to undergo transcatheter aortic valve implantation (TAVI) or transcatheter aortic valve replacement (TAVR), or off-pump surgeries or left ventricular assist device (LVAD) implantation
- Experiences a cardiogenic shock or hemodynamic instability which require inotropes or vasopressors or other mechanical devices within 24 hours prior to surgery
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 |
|---|---|---|
| RMC-035Also: ROSgardConcentrate for Solution for Infusion | Drug | RMC-035 |
| PlaceboConcentrate for Solution for Infusion | Drug | Placebo |
Primary outcome
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
Time frame: 72 hours
Percentage of subjects developing AKI based on Serum Creatinine and/or Urine Output per KDIGO definition
21 secondary outcomes
Area Under the Curve (AUC) of Serum Creatinine (SCr)
Time frame: 72 hours
Duration of AKI
Time frame: 90 days
Change in SCr Values Over Time
Time frame: 90 days
Peak Cystatin C Value
Time frame: 7 days
AUC of Cystatin C
Time frame: 72 hours
Number of Participants Requiring Renal Replacement Therapy (Dialysis)
Time frame: 7 days
Number of Days Without Need for Dialysis
Time frame: 90 days
Major Adverse Kidney Event (MAKE) - SCr
Time frame: 90 days
AKI Within 72 Hours Based on Cystatin C and UO
Time frame: 72 hours
AKI Within 7 Days
Time frame: 7 days
Persistence of AKI
Time frame: 7 days
Severity of AKI
Time frame: 7 days
Change in Urine Albumin to Creatinine Ratio (UACR) and Urine Protein to Creatinine Ratio (UPCR)
Time frame: 90 days
Pharmacokinetics of RMC-035 (AUC)
Time frame: 4 days
Pharmacokinetics of RMC-035 (Cmax)
Time frame: 7 days
Presence of Anti-drug Antibodies (ADA)
Time frame: 90 days
Characteristics of ADA (Cross-reactivity)
Time frame: 90 days
Peak SCr Value
Time frame: 7 days
Major Adverse Kidney Event (MAKE) - Cystatin C
Time frame: 90 days
Major Adverse Kidney Event (MAKE) - SCr and Cystatin C
Time frame: 90 days
Change in Serum Cystatin C Values Over Time
Time frame: 90 days
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 16 May 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
- Derived from this study: PubMed 39318788Zarbock A, Larsson TE, Noiseux N, Mazer CD, Bohm J, Laflamme M, Matschke K, Burkert J, de Varennes B, Myjavec A, Boning A, Koyner JL, Engelman D, Reusch M, Thielmann M; AKITA investigators. Efficacy and safety of therapeutic alpha-1-microglobulin RMC-035 in reducing kidney injury after cardiac surgery: a multicentre, randomised, double-blind, parallel group, phase 2a trial. EClinicalMedicine. 2024 Sep 16;76:102830. doi: 10.1016/j.eclinm.2024.102830. eCollection 2024 Oct.
- Derived from this study: PubMed 37024249Mazer CD, Siadati-Fini N, Boehm J, Wirth F, Myjavec A, Brown CD, Koyner JL, Boening A, Engelman DT, Larsson TE, Renfurm R, de Varennes B, Noiseux N, Thielmann M, Lamy A, Laflamme M, von Groote T, Ronco C, Zarbock A. Study protocol of a phase 2, randomised, placebo-controlled, double-blind, adaptive, parallel group clinical study to evaluate the efficacy and safety of recombinant alpha-1-microglobulin in subjects at high risk for acute kidney injury following open-chest cardiac surgery (AKITA trial). BMJ Open. 2023 Apr 6;13(4):e068363. doi: 10.1136/bmjopen-2022-068363.
- Individual participant dataSharing planned: No
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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.
Tobias Agervald, MD study director
Guard Therapeutics
Alexander Zarbock, MD principal investigator
Muenster University Hospital
29 sites in 5 countries: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing RMC-035 in people with Acute Kidney Injury, run by Guard Therapeutics AB at 29 sites in 5 countries.
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 11 inclusion and 17 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: stopped early, as of the sponsor's last update on 16 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 29 sites in United States, Germany, Canada, Spain, Czechia. 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?
Yes. Results are posted in the registry (first posted 16 May 2024). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.
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?
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria (time frame: 72 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 NCT05126303, which also lists 2 linked publications.
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 16 May 2024.