Acute Kidney Injury (AKI)Phase 1NCT04829916
A Study to Evaluate RMC-035 in Subjects Undergoing Cardiac Surgery
A Phase 1 study testing RMC-035 in people with Acute Kidney Injury (AKI), run by Guard Therapeutics AB at 1 site in Germany.
Trial summary
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Acute Kidney Injury (AKI)
- 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
- 13 participants
- Where
- 1 siteGermany
- Study dates
- 16 Mar 2021to 15 Jul 2021
- Phase
- Phase 1
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Female and male subjects with an age ≥18 years
- Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
- Subject has at least ONE of the following risk factors for AKI at screening:
- History of LVEF <35% for at least 3 months prior to screening assessed by either echocardiography, cardiac MRI or nuclear scan.
- History of previous open chest cavity cardiac surgery with or without CPB
- Confirmed diagnosis of type 2 diabetes (T2DM) at least 3 months prior to screening AND ongoing treatment with an approved anti-diabetic drug
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- Age ≥70 years
- Documented history of heart failure NYHA class II or higher for at least 3 months or longer at screening
- Documented history of previous AKI before date of screening independent of the etiology of AKI
- Documented history of anemia with hemoglobin ≤ 11 g/dL (≤6.8 mmol/L) for at least 3 months prior to screening
- Documented history of albuminuria, defined as UACR >30 mg/g or > 30 mg/24 hour in a 24-hour urine collection.
- eGFR is ≤ 60 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation
Who cannot join
- Estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline
- Subject has surgery scheduled to be performed without CPB ("off-pump")
- Subject has surgery scheduled for aortic dissection
- Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
- Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation
- Subject has a requirement for any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support (MCS) (Note: The prophylactic insertion of an IABP preoperatively for reasons not related to existing LV pump function is not exclusionary)
Trial locations and contacts
1 site in 1 country.
About this study
Official title: A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
Read the detailed description
This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.
- Conditions
- Acute Kidney Injury (AKI)
- Being tested
- RMC-035, Placebo
- Keywords
- AKI
- 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 Solution for injection
Multiple dosing during 48 hours following cardiac surgery
PlaceboDrug
Also called Solution for injection
Multiple dosing during 48 hours following cardiac surgery
| Study group | Role | What they receive |
|---|---|---|
| RMC-035 | Experimental | Participants will receive RMC-035 intravenously Receives: Drug: RMC-035 |
| Placebo | Placebo comparator | Participants will receive matching placebo solution intravenously Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Frequency of Adverse Events (AEs)
- number (%) of subjects with at least one AE
- number (%) of subjects with at least one SAE
- number (%) of subjects with at least one Treatment-Emergent AE (TEAE)
- number (%) of subjects with at least one serious TEAE
- number (%) of subjects with at least one non-serious TEAE
- number (%) of subjects with at least one TEAE of special interest
- number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP
- number (%) of subjects with at least one TEAEs leading to withdrawal of IMP
Measured: Baseline through day 30
Severity of AEs
- Number of TEAEs per category (mild, moderate, severe life-threatening, death)
Measured: Within 4 days from first dose of IMP
Secondary outcomes (3)
Maximum Observed Concentration (Cmax)
Analysis of RMC-035 concentration in plasma (AUC + t1/2) after fourth infusion.
Measured: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Area Under the Curve (AUC) 0-24h
Analysis of RMC-035 concentrations in plasma following the fourth infusion.
Measured: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Elimination Half-life (T1/2)
Analysis of RMC-035 concentration in plasma following the fourth infusion
Measured: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Apr 2021
- Study start16 Mar 2021
- Primary completion15 Jul 2021
- Study completion15 Jul 2021
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.
- Other trials for Acute Kidney Injury (AKI)Studies 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 1
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guard Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Tobias Agervald, MD PhD, Study director, Guard Therapeutics AB
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT04829916
- Sponsor's protocol ID
- 20-ROS-04
- Status last verified
- Apr 2024
- First submitted
- 26 Mar 2021
- Last updated
- 23 Apr 2024
- Results posted
- Yes, on ClinicalTrials.gov
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1b, Randomised, Double-Blind, Parallel Treatment Group Clinical Study to Evaluate the Safety, Tolerability and Pharmacokinetics of RMC-035 in Subjects Undergoing Non-Emergent On-Pump Coronary Artery Bypass Graft and/or Valve Surgery
- ClinicalTrials.gov ID
- NCT04829916
- Acronym / sponsor ID
- 20-ROS-04
- Conditions
- Acute Kidney Injury (AKI)
- Keywords
- AKI
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Guard Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 16 Mar 2021 (actual)
- Primary completion
- 15 Jul 2021 (actual)
- Study completion
- 15 Jul 2021 (actual)
- First posted
- 2 Apr 2021 (actual)
- Results
- Posted 4 Dec 2023
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of the clinical study is to assess safety, tolerability and pharmacokinetics of RMC-035 for the prevention and treatment of acute kidney injury (AKI) in patients undergoing cardiac surgery.
Detailed description
This is a study with two parallel treatment groups where subjects are randomized to receive RMC-035 or a matching placebo in a double-blind fashion. The study will comprise of a screening visit, followed by CABG and/or valve replacement on Day 1, double-blind treatment period and a follow-up period up to Day 30.
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 |
|---|---|---|
| RMC-035 | Experimental | Drug: RMC-035Participants will receive RMC-035 intravenously |
| Placebo | Placebo comparator | Drug: PlaceboParticipants will receive matching placebo solution intravenously |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- Female and male subjects with an age ≥18 years
- Subject is scheduled for non-emergent (elective) CABG and/or valve surgery (single or multiple valves) with use of cardiopulmonary bypass (CPB)
- Subject has at least ONE of the following risk factors for AKI at screening:
Key exclusion criteria (6 listed)
- Estimated glomerular filtration rate (eGFR) is <30 mL/min/1.73 m2 using the Chronic Kidney Disease - Epidemiology Collaboration (CKD-EPI) equation at screening or at baseline
- Subject has surgery scheduled to be performed without CPB ("off-pump")
- Subject has surgery scheduled for aortic dissection
- Subject is scheduled for CABG and/or valve surgery combined with additional non-emergent cardiac surgeries, e.g. for atrial fibrillation ablation
- Subject is scheduled to undergo trans catheter aortic valve implantation (TAVI) or trans catheter aortic valve replacement (TAVR), or single vessel off-pump surgeries or left ventricular device (LVAD) implantation
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: Solution for injectionMultiple dosing during 48 hours following cardiac surgery | Drug | RMC-035 |
| PlaceboAlso: Solution for injectionMultiple dosing during 48 hours following cardiac surgery | Drug | Placebo |
Primary outcome
Frequency of Adverse Events (AEs)
Time frame: Baseline through day 30
* number (%) of subjects with at least one AE * number (%) of subjects with at least one SAE * number (%) of subjects with at least one Treatment-Emergent AE (TEAE) * number (%) of subjects with at least one serious TEAE * number (%) of subjects with at least one non-serious TEAE * number (%) of subjects with at least one TEAE of special interest * number (%) of subjects with at least one TEAEs reported as related (possible/probable) to IMP * number (%) of subjects with at least one TEAEs leading to withdrawal of IMP
Severity of AEs
Time frame: Within 4 days from first dose of IMP
- Number of TEAEs per category (mild, moderate, severe life-threatening, death)
3 secondary outcomes
Maximum Observed Concentration (Cmax)
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Area Under the Curve (AUC) 0-24h
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Elimination Half-life (T1/2)
Time frame: Blood samples taken from pre-dose and up to two hours after start of Dose 5
Results and safety
Loading the posted results from ClinicalTrials.gov…
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2024.
- Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
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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 PhD study director
Guard Therapeutics AB
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing RMC-035 in people with Acute Kidney Injury (AKI), run by Guard Therapeutics AB at 1 site in Germany.
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 12 inclusion and 6 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 Apr 2024. 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 Germany. 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 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
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 4 Dec 2023). 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?
Frequency of Adverse Events (AEs) (time frame: Baseline through day 30). 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?
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 Apr 2024.