Kidney Injury Following Open-Chest Cardiac SurgeryPhase 2POINTERNCT06475274
A Phase 2b Dose Finding Study of RMC-035 in Participants Undergoing Open-chest Cardiac Surgery
A Phase 2 study testing RMC-035 in people with Kidney Injury Following Open-Chest Cardiac Surgery, run by Guard Therapeutics AB at 19 sites in 4 countries.
Trial summary
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. Read more about this study
- Who is it for?
- Ages 18 to 84 years
- Conditions the study is for
- Kidney Injury Following Open-Chest Cardiac Surgery
- 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
- 170 participants
- Where
- 19 sitesin 4 countries
- Study dates
- 26 Aug 2024to 11 Sep 2025
- 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 to 84 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- eGFR ≥30 ml/min/1.73m2
- Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery
- Risk factors for acute kidney injury are present
- Participant capable of providing written informed consent
- Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm
Who cannot join
- Any medical condition that makes the participant unsuitable
- Scheduled for emergent surgeries
- Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
- 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 such as intraaortic balloon pumping (IABP) within 24 hours prior to surgery
- Requires any of the following within one week prior to surgery: defibrillator or permanent pacemaker, mechanical ventilation, IABP, LVAD, other forms of mechanical circulatory support.
Show all 19Show fewer
- Diagnosed with AKI prior to surgery
- Requires cardiopulmonary resuscitation prior to surgery
- Ongoing sepsis or an untreated diagnosed clinically significant infection
- Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) ≥3.0 times the upper limit of normal (ULN).
- Total bilirubin ≥2.0 time ULN
- History of solid organ transplantation
- History of renal replacement therapy
- Severe allergic asthma
- Chronic immunosuppressive treatment that may have an impact on kidney function
- Ongoing chemotherapy or radiation therapy for malignancy that may have an impact on kidney function
- Current enrolment or past recent participation in any other clinical study involving an investigational study treatment
- Previously treatment of RMC-035
- Sensitivity to any of the study interventions, or components thereof
Trial locations and contacts
19 sites in 4 countries.
19 sites in 4 countries
Germany6 sites
Research site 5
Dresden
Research site 3
Essen
Research site 6
Giessen
Research site 4
Halle
Research site 2
München
Research site 1
Münster
Spain6 sites
Research site 3
Barcelona
Research site 4
Córdoba
Research site 1
Madrid
Research site 2
Madrid
Research site 6
Pamplona
Research site 5
Santiago de Compostela
Canada5 sites
Research site 4
Montreal
Research site 5
Montreal
Research site 2
Québec
Research site 3
Saint John
Research site 1
Toronto
About this study
Official title: A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery
The goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is:
- Does RMC-035 protect the function of kidneys after surgery?
- Is RMC-035 safe?
Read more
Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if
- Kidney function better for participants treated with any of the RMC-035 doses?
- What medical problems do participants have when receiving RMC-035?
Participants will
- Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery
- Have extra checkups and tests during their hospital stay
- Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests
- Being tested
- RMC-035, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
RMC-035Drug
Protein, a recombinant variant of A1M. Concentrate for solution for infusion.
PlaceboDrug
Identical to RMC-035 intervention devoid of the active substance.
| Study group | Role | What they receive |
|---|---|---|
| RMC-035 high-dose | Experimental | RMC-035 60 mg Receives: Drug: RMC-035 |
| RMC-035 low-dose | Experimental | RMC-035 30 mg Receives: Drug: RMC-035 |
| Placebo | Placebo comparator | Placebo (tris-buffer) Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)
Difference in estimated glomerular filtration rate (eGFR) at Day 90 (end of study) compared to baseline.
Measured: 90 days
Secondary outcomes (1)
Occurrence of MAKE (and each MAKE component) at Day 90
Occurrence of major adverse kidney events (MAKE), consisting of the following components: death, any new renal replacement therapy (RRT) after surgery, or sustained loss of kidney function, defined as a 25% or greater decline in eGFR, until 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 posted26 Jun 2024
- Study start26 Aug 2024
- Primary completion11 Sep 2025
- Study completion11 Sep 2025
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 Kidney Injury Following Open-Chest Cardiac SurgeryStudies 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
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 170 participants (actual)
Sponsor and investigators
- Lead sponsor
- Guard Therapeutics AB
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Michael Reusch, MD, Study director, Guard Therapeutics
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06475274
- Sponsor's protocol ID
- 24-ROS-07
- Acronym
- POINTER
- Status last verified
- Oct 2025
- First submitted
- 20 Jun 2024
- Last updated
- 2 Oct 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- Yes
- FDA-regulated device
- No
Publications
Zarbock A, Strauss C, Laflamme M, Myjavec A, Bohm J, Burkert J, Mazer CD, de Varennes B, Iglesias AG, Matschke K, Larsson TE, Reusch M; POINTER study group. POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery. Trials. 2025 Oct 28;26(1):449. doi: 10.1186/s13063-025-09124-x.
PubMed 41152991
Study at a glance
From the registry record, last updated by the sponsor on 2 Oct 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Randomized, Placebo-Controlled, Double-Blind, Parallel Group Dose-Finding Study to Evaluate the Efficacy on Renal Function and Safety of RMC-035 in Participants at High Risk for Kidney Injury Following Open-Chest Cardiac Surgery
- ClinicalTrials.gov ID
- NCT06475274
- Acronym / sponsor ID
- POINTER / 24-ROS-07
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 170 participants (actual)
- Lead sponsor
- Guard Therapeutics ABIndustry (pharma, biotech, devices)
- Study start
- 26 Aug 2024 (actual)
- Primary completion
- 11 Sep 2025 (actual)
- Study completion
- 11 Sep 2025 (actual)
- First posted
- 26 Jun 2024 (actual)
- 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 goal of this clinical trial is to identify the optimal dose of RMC-035 for protection of long-term renal function in adult patients undergoing cardiac surgery who are at high risk of kidney injury. It will also learn about the safety of RMC-035. The main question it aims to answer is:
- Does RMC-035 protect the function of kidneys after surgery?
- Is RMC-035 safe?
Researchers will compare RMC-035 in high dose, RMC-035 in low dose and placebo to see if
- Kidney function better for participants treated with any of the RMC-035 doses?
- What medical problems do participants have when receiving RMC-035?
Participants will
- Receive 3 doses of RMC-035 or placebo: at the beginning of surgery, end of surgery and 24h after surgery
- Have extra checkups and tests during their hospital stay
- Visit the clinic at two extra occasions at 60 days and 90 days after surgery for checkups and tests
Study design
- Primary purpose
- Prevention
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| RMC-035 high-dose | Experimental | Drug: RMC-035RMC-035 60 mg |
| RMC-035 low-dose | Experimental | Drug: RMC-035RMC-035 30 mg |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo (tris-buffer) |
Who may qualify
- Ages
- 18 to 84 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- eGFR ≥30 ml/min/1.73m2
- Scheduled for non-emergent surgery of any of the following types, with use of cardiopulmonary bypass (CPB): coronary artery bypass grafting (CABG), valve surgery, ascending aorta aneurysm surgery
- Risk factors for acute kidney injury are present
- Participant capable of providing written informed consent
- Participant agrees to study restrictions such as not to take part in another interventional study, use contraception and not donate ova or sperm
Key exclusion criteria (19 listed)
- Any medical condition that makes the participant unsuitable
- Scheduled for emergent surgeries
- Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
- 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 such as intraaortic balloon pumping (IABP) 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-035Protein, a recombinant variant of A1M. Concentrate for solution for infusion. | Drug | RMC-035 high-dose, RMC-035 low-dose |
| PlaceboIdentical to RMC-035 intervention devoid of the active substance. | Drug | Placebo |
Primary outcome
Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)
Time frame: 90 days
Difference in estimated glomerular filtration rate (eGFR) at Day 90 (end of study) compared to baseline.
1 secondary outcome
Occurrence of MAKE (and each MAKE component) at Day 90
Time frame: 90 days
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 2 Oct 2025.
- Derived from this study: PubMed 41152991Zarbock A, Strauss C, Laflamme M, Myjavec A, Bohm J, Burkert J, Mazer CD, de Varennes B, Iglesias AG, Matschke K, Larsson TE, Reusch M; POINTER study group. POINTER: study protocol for a phase 2b, randomised, placebo-controlled, double-blind, parallel group dose-finding clinical study to evaluate the efficacy of RMC-035 on renal function and safety, in participants at high risk for kidney injury, following open-chest cardiac surgery. Trials. 2025 Oct 28;26(1):449. doi: 10.1186/s13063-025-09124-x.
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.
Michael Reusch, MD study director
Guard Therapeutics
19 sites in 4 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 Kidney Injury Following Open-Chest Cardiac Surgery, run by Guard Therapeutics AB at 19 sites in 4 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 5 inclusion and 19 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 2 Oct 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 19 sites in Germany, Spain, Canada, 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?
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?
Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo) (time frame: 90 days). 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 NCT06475274, 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 2 Oct 2025.