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RMC-035 for Acute Kidney Injury (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
Awards & highlights

AKITA Trial Summary

This trial will compare RMC-035 to placebo in order to prevent AKI in high-risk subjects following cardiac surgery.

Eligible Conditions
  • Acute Kidney Injury

AKITA Trial 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

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Percentage of Subjects Developing AKI, as Defined Per Kidney Disease Improving Global Outcomes (KDIGO) Criteria
Secondary outcome measures
AKI Within 7 Days
AKI Within 72 Hours Based on Cystatin C and UO
AUC of Cystatin C
+18 more

Side effects data

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

AKITA 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
1 Previous Clinical Trials
13 Total Patients Enrolled
1 Trials studying Acute Kidney Injury
13 Patients Enrolled for Acute Kidney Injury
Alexander Zarbock, MDPrincipal InvestigatorMuenster University Hospital
8 Previous Clinical Trials
2,067 Total Patients Enrolled
5 Trials studying Acute Kidney Injury
1,227 Patients Enrolled for Acute Kidney Injury
Tobias Agervald, MDStudy DirectorGuard Therapeutics
~56 spots leftby May 2025
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