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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
Proportion of subjects developing AKI, as defined per Kidney Disease Improving Global Outcomes (KDIGO) criteria
Safety and Tolerability
Secondary outcome measures
AKI Characteristics: AKI within 7 days
AKI Characteristics: AKI within 72 hours based on cystatin C and UO
AKI Characteristics: Persistence
+13 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
Tobias Agervald, MDStudy DirectorGuard Therapeutics
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

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any available positions for volunteers in this research?

"That is correct. The clinical trial in question, which was originally posted on March 31st, 2022, is still recruiting patients according to information found on clinicaltrials.gov. Currently, 268 people are needed for the study across 15 different locations."

Answered by AI

Is this clinical trial available to people who are not yet 85 years old?

"This particular clinical trial is only enrolling patients that fall between the ages of 18 to 84. In contrast, there are 129 other trials for minors and 696 research studies available for elderly patients."

Answered by AI

How many patients are agreeing to participate in this research project?

"That is correct. The information available on clinicaltrials.gov reveals that the trial is still ongoing and recruiting participants. The 268 people needed for the study are being recruited from 15 different hospitals or research centres."

Answered by AI

For which patient population is this research study applicable?

"This clinical trial is open to 268 people with acute kidney injury who meet the following criteria: they must be between 18 and 84 years old, have an estimated glomerular filtration rate of at least 30 mL/min/1.73 m2, be scheduled for non-emergent coronary artery bypass grafting surgery, valve surgery, or ascending aorta aneurysm surgery with use of cardiopulmonary bypass, and have AKI risk factors present at screening. Additionally, female subjects must not be of childbearing potential or breastfeeding, male subjects must not donate sperm, and all subjects must use a"

Answered by AI

Could you tell me how many different hospitals are part of this study?

"This trial is based out of the Jacksonville Center for Clinical Research in Jacksonville, Nebraska; Hamilton Health Sciences in Hamilton, Texas; Bryan Heart in Lincoln, Indiana; and 15 other medical centres."

Answered by AI

What is the status of RMC-035 in regards to government regulation?

"While there is some data supporting the safety of RMC-035, as this is a Phase 2 trial, none of it suggests that the medication is effective. Therefore, our team at Power has given it a score of 2."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery
2022. "Efficacy and Safety of RMC-035 in Subjects at High Risk for Acute Kidney Injury Following Open-Chest Cardiac Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT05126303.
~59 spots leftby Apr 2025
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