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Iron Chelator

Low Dose RBT-1 for Acute Kidney Injury (START Trial)

Phase 2
Waitlist Available
Research Sponsored by Renibus Therapeutics, Inc.
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 baseline through day 5 post-cardiac surgery
Awards & highlights

START Trial Summary

This trial will test if RBT-1 can help reduce risk of AKI in people undergoing heart surgery.

START Trial Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~baseline through pre-surgery
This trial's timeline: 3 weeks for screening, Varies for treatment, and baseline through pre-surgery for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Evaluate the Efficacy of RBT-1 in Generating a Preconditioning Response as Measured by a Composite of Biomarkers
Secondary outcome measures
Change in Renal Tubular Injury Biomarkers
Number of Subjects With Acute Kidney Injury (AKI)
Number of Subjects With Reduction in Urine Output

Side effects data

From 2023 Phase 2 trial • 152 Patients • NCT04564833
30%
Nausea
26%
Hypotension
24%
Atelectasis
22%
Photosensitivity reaction
22%
Atrial fibrillation
20%
Pleural effusion
20%
Procedural pain
13%
Urine output decreased
13%
Anemia
11%
Constipation
11%
Hyperglycemia
11%
Urinary tract infection
11%
Hypervolemia
9%
Leukocytosis
9%
Incision site pain
7%
Dyspnea
7%
Subcutaneous emphysema
7%
Diarrhea
7%
Acute kidney injury
7%
Pulmonary edema
7%
Edema peripheral
7%
Generalized edema
4%
Cardiomegaly
4%
Chest pain
4%
Thrombocytopenia
4%
Photosensitivity
4%
Edema
4%
Insomnia
2%
Dizziness
2%
Cardiac failure congestive
2%
Duodenal ulcer hemorrhage
2%
Wound infection
2%
Transient global amnesia
2%
Pneumothorax
2%
Sepsis
2%
Non-cardiac chest pain
2%
Acute respiratory failure
2%
Cerebral infarction
2%
Pneumonia
2%
Device dislocation
2%
Delirium
2%
Atrioventricular block complete
2%
Bradycardia
2%
Pericardial effusion
2%
Breath sounds abnormal
2%
Blood loss anemia
2%
Ventricular fibrillation
2%
Carbon dioxide increased
2%
Respiratory failure
2%
Upper airway obstruction
2%
Pain
2%
Atrial flutter
2%
Hallucination
2%
Abdominal distention
2%
Cardiogenic shock
2%
Ventricular tachycardia
2%
Gastrointestinal hemorrhage
100%
80%
60%
40%
20%
0%
Study treatment Arm
High Dose RBT-1
Low Dose RBT-1
Placebo

START Trial Design

3Treatment groups
Experimental Treatment
Placebo Group
Group I: Low Dose RBT-1Experimental Treatment1 Intervention
Single IV infusion prior to cardiac surgery
Group II: High Dose RBT-1Experimental Treatment1 Intervention
Single IV infusion prior to cardiac surgery
Group III: PlaceboPlacebo Group1 Intervention
Single IV infusion prior to cardiac surgery
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Low Dose RBT-1
2021
Completed Phase 2
~160
High Dose RBT-1
2021
Completed Phase 2
~160

Find a Location

Who is running the clinical trial?

Renibus Therapeutics, Inc.Lead Sponsor
7 Previous Clinical Trials
956 Total Patients Enrolled
4 Trials studying Acute Kidney Injury
114 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.

Has the FDA given Low Dose RBT-1 the green light?

"While there is some prior data attesting to Low Dose RBT-1's safety, it received a score of 2 because there are no studies demonstrating its efficacy."

Answered by AI

How many research sites are participating in this trial?

"There are a total of 21 enrolment sites for this trial, which include Heart Center Research, LLC in Huntsville, Alabama; Brigham and Women's Hospital in Washington, District of Columbia; Keck Hospital of USC in Boston, Massachusetts; and 19 other locations."

Answered by AI

Is this a new or unique study?

"Currently, the only ongoing clinical trial for Low Dose RBT-1 is taking place in 26 cities across 3 countries. The first trial for this medication was conducted in 2021 and involved 126 patients. The study successfully completed Phase 2 approval and 18294 trials have been conducted since then."

Answered by AI

Are there other precedents for using RBT-1 in small dosages?

"Currently, 1 trial for Low Dose RBT-1 is active with 0 trials in Phase 3. Additionally, 27 sites are running these tests while the majority of them are situated in Hyattsville, Maryland."

Answered by AI

Is there room for more people in this research project?

"That is correct. The clinicaltrials.gov website indicates that the trial is still recruiting patients, with an initial posting date of April 30th, 2021 and a most recent update on October 14th, 2022. Thus far, 126 individuals have been enrolled across 19 different sites."

Answered by AI

How many total patients will be included in this research project?

"In order to run this trial, 126 patients that meet the prerequisites need to agree to participate. These potential participants can be found at different locations, such as Heart Center Research, LLC in Huntsville, Alabama and Brigham and Women's Hospital in Washington D.C."

Answered by AI
Recent research and studies
clinicaltrials.govStudy
Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery
2021. "Effect of RBT-1 on Preconditioning Response Biomarkers in Subjects Undergoing CABG and/or Cardiac Valve Surgery". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04564833.
~41 spots leftby Apr 2025
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