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Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery (AKITA Trial)
Phase 2
Waitlist Available
Led By Alexander Zarbock, MD
Research Sponsored by Guard Therapeutics AB
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 90 days
Summary
This trial tests RMC-035 to see if it can prevent kidney problems in patients who are at high risk after heart surgery. Half of the patients will get RMC-035, and the other half will get a different treatment.
Eligible Conditions
- Acute Kidney Injury
- Acute Kidney Failure
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 90 days
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~90 days
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
Secondary study objectives
AKI Within 7 Days
AKI Within 72 Hours Based on Cystatin C and UO
AUC of Cystatin C
+18 moreSide effects data
From 2021 Phase 1 trial • 13 Patients • NCT0482991638%
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
2Treatment groups
Experimental Treatment
Placebo Group
Group I: RMC-035Experimental Treatment1 Intervention
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.
Group II: PlaceboPlacebo Group1 Intervention
Identical to RMC-035 arm except that the placebo contains no active ingredient.
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
174 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
13 Patients Enrolled for Acute Kidney Injury
Tobias Agervald, MDStudy DirectorGuard Therapeutics
Alexander Zarbock, MDPrincipal InvestigatorMuenster University Hospital
10 Previous Clinical Trials
3,346 Total Patients Enrolled
7 Trials studying Acute Kidney Injury
2,506 Patients Enrolled for Acute Kidney Injury