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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

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

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 90 days

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

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 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%

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

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