OCE-205 for Acute Kidney Injury

Phase-Based Progress Estimates
1
Effectiveness
2
Safety
Acute Kidney Injury+7 More
OCE-205 - Drug
Eligibility
18+
All Sexes
What conditions do you have?
Select

Study Summary

This trial is testing a new drug to treat people who have developed a complication of cirrhosis called acute kidney injury. The drug will be given through an IV, and the goal is to see if it is safe and effective.

Eligible Conditions
  • Acute Kidney Injury
  • Ascites
  • Cirrhosis of the Liver
  • Hepatorenal Syndrome

Treatment Effectiveness

Effectiveness Progress

1 of 3

Study Objectives

2 Primary · 18 Secondary · Reporting Duration: From Day 1 infusion start to Last Day of infusion end

Day 1
Average Steady State Concentration (Css) of OCE-205
Change in Mean Arterial Pressure (MAP) Percentage
Change in Mean Arterial Pressure (MAP) measurement
Systemic arterial pressure
Change in Pulse Measurement
Change in Pulse Percentage
Change in Pulse Rate
Change in Serum Creatinine (sCr) Measurement
Change in concentration of Serum Creatinine (sCr)
Elimination Half-Life (t1/2) of OCE-205
Mean Concentration of OCE-205 at Steady State Concentration (Css)
Pulse Rate
Mean blood pressure
Rate of Total Body Clearance (CL) of OCE-205
Steady-State Volume of Distribution (Vss) of OCE-205
Time to Elimination Half-Life (t1/2) of OCE-205
Time to measurement of concentration serum creatinine (sCr) value of less than 1.5 mg/dL on 2 consecutive days
Time to measurement of serum creatinine (sCr) value less than 1.5 mg/dL on 2 consecutive days
Total Body Clearance (CL) of OCE-205
Volume of Steady-State Volume of Distribution (Vss) of OCE-205

Trial Safety

Safety Progress

2 of 3
This is further along than 68% of similar trials

Trial Design

5 Treatment Groups

OCE-205 Cohort 2
1 of 5
OCE-205 Cohort 4
1 of 5
OCE-205 Cohort 3
1 of 5
OCE-205 Cohort 5
1 of 5
OCE-205 Cohort 1
1 of 5

Experimental Treatment

Non-Treatment Group

100 Total Participants · 5 Treatment Groups

Primary Treatment: OCE-205 · Has Placebo Group · Phase 2

OCE-205 Cohort 2
Drug
Experimental Group · 1 Intervention: OCE-205 · Intervention Types: Drug
OCE-205 Cohort 4
Drug
Experimental Group · 1 Intervention: OCE-205 · Intervention Types: Drug
OCE-205 Cohort 3
Drug
Experimental Group · 1 Intervention: OCE-205 · Intervention Types: Drug
OCE-205 Cohort 5
Drug
Experimental Group · 1 Intervention: OCE-205 · Intervention Types: Drug
OCE-205 Cohort 1
Drug
PlaceboComparator Group · 1 Intervention: Placebo · Intervention Types: Drug

Trial Logistics

Trial Timeline

Screening: ~3 weeks
Treatment: Varies
Reporting: from day 1 infusion start to last day of infusion end

Who is running the clinical trial?

Ocelot Bio, IncLead Sponsor
Chief Medical and Scientific OfficerStudy ChairOcelot Bio

Eligibility Criteria

Age 18+ · All Participants · 6 Total Inclusion Criteria

Mark “Yes” if the following statements are true for you:
You have no sustained improvement in renal function after both diuretic withdrawal and plasma volume expansion with albumin.
Beta-blockers should be discontinued 48 hours prior to randomization, unless doctor deems necessary for appropriate medical treatment.

About The Reviewer

Michael Gill preview

Michael Gill - B. Sc.

First Published: October 24th, 2021

Last Reviewed: November 24th, 2022

Michael Gill holds a Bachelors of Science in Integrated Science and Mathematics from McMaster University. During his degree he devoted considerable time modeling the pharmacodynamics of promising drug candidates. Since then, he has leveraged this knowledge of the investigational new drug ecosystem to help his father navigate clinical trials for multiple myeloma, an experience which prompted him to co-found Power Life Sciences: a company that helps patients access randomized controlled trials.

Who else is applying?

How old are they?
18 - 65100.0%
What site did they apply to?
Toronto General Hospital100.0%
What portion of applicants met pre-screening criteria?
Did not meet criteria100.0%
References