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RMC-035 for Acute Kidney Injury (POINTER Trial)

Phase 2
Recruiting
Research Sponsored by Guard Therapeutics AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
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
Must not have
Scheduled for emergent surgeries
Scheduled for CABG and/or valve surgery and/or ascending aorta aneurysm surgery combined with additional non-emergent cardiac surgeries
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days

Summary

This trial aims to find the best dose of RMC-035 to protect the kidneys of adult patients undergoing heart surgery. Researchers want to know if RMC-035 can help improve kidney function after surgery

Who is the study for?
This trial is for adult patients undergoing open-chest cardiac surgery who are at high risk of acute kidney injury. Participants will receive three doses of either RMC-035 or a placebo during and after their surgery, with additional checkups and tests during their hospital stay and follow-up visits at 60 and 90 days post-surgery.
What is being tested?
The study is testing the effectiveness of two different doses of RMC-035 compared to a placebo in protecting long-term kidney function after cardiac surgery. It aims to determine the optimal dose for renal protection and assess the safety profile of RMC-035.
What are the potential side effects?
While specific side effects are not listed, participants will be monitored for any medical problems that arise from receiving RMC-035. Safety assessments will include tracking all adverse events related to the drug.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am scheduled for heart surgery that requires a heart-lung machine.
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I am at risk for sudden kidney damage.
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My kidney function is at a safe level for treatment.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I am scheduled for an urgent surgery.
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I am scheduled for heart surgery, including for blocked arteries, valve issues, or an aorta aneurysm.
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I am scheduled for a specific heart valve procedure or surgery without using a heart-lung machine.
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I needed strong heart medications or devices to stabilize my blood pressure before surgery.
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I was diagnosed with acute kidney injury before surgery.
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I have severe allergic asthma.
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I have been treated with RMC-035 before.
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I do not have an ongoing serious infection or untreated sepsis.
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I have been on dialysis.
Select...
I needed CPR before my surgery.
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I have had a solid organ transplant.

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
This trial's timeline: 3 weeks for screening, Varies for treatment, and 90 days for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.
Primary study objectives
Change from baseline in eGFR at Day 90 (the two arms of RMC-035 pooled compared against placebo)
Secondary study objectives
Occurrence of MAKE (and each MAKE component) at Day 90
Other study objectives
ADA activity of neutralizing native A1M
ADA isotype
Change from baseline in Cystatin C until Day 7
+9 more

Side effects data

From 2021 Phase 1 trial • 13 Patients • NCT04829916
38%
Pleural effusion
25%
Acute kidney injury
13%
Cardiac tamponade
13%
Impaired healing
13%
Large intestine perforation
13%
Postoperative wound infection
13%
Anaphylactoid reaction
13%
Small intestinal haemorrhage
13%
Thrombocytopenia
13%
Urinary tract infection
13%
Pericardial effusion
13%
Hypothyroidism
13%
Rib fracture
100%
80%
60%
40%
20%
0%
Study treatment Arm
RMC-035
Placebo

Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: RMC-035 low-doseExperimental Treatment1 Intervention
RMC-035 30 mg
Group II: RMC-035 high-doseExperimental Treatment1 Intervention
RMC-035 60 mg
Group III: PlaceboPlacebo Group1 Intervention
Placebo (tris-buffer)
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
RMC-035
2021
Completed Phase 1
~20

Find a Location

Who is running the clinical trial?

Guard Therapeutics ABLead Sponsor
2 Previous Clinical Trials
190 Total Patients Enrolled
2 Trials studying Acute Kidney Injury
190 Patients Enrolled for Acute Kidney Injury
Michael Reusch, MDStudy DirectorGuard Therapeutics
~103 spots leftby Oct 2025
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