Gemini for Chronic Kidney Disease
(PRIME Trial)
What You Need to Know Before You Apply
What is the purpose of this trial?
Gemini is being evaluated in a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult subjects with stage 3 or 4 chronic kidney disease. Pharmacokinetics will be evaluated and measurements of the effect of Gemini on pharmacodynamic activity will be measured to assess changes in potential pharmacodynamic markers.
Will I have to stop taking my current medications?
You may need to stop taking certain medications, especially if you are on drugs like SGLT2 inhibitors, MRAs, TNF inhibitors, or ACE inhibitors that require dose adjustments. It's best to discuss your current medications with the study team to see if any changes are needed.
Who Is on the Research Team?
Chief Executive Officer
Principal Investigator
Revelation Biosciences, Inc
Are You a Good Fit for This Trial?
Adults with stage 3 or 4 chronic kidney disease can join this trial. It's not for people who need dialysis or have other specific health conditions that aren't listed here.Inclusion Criteria
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive a single intravenous dose of Gemini or placebo, with dose escalation based on safety and tolerability
Safety Monitoring
Participants are monitored for safety and tolerability, including adverse events and pharmacokinetics, up to Day 8
Follow-up
Participants are monitored for safety and effectiveness after treatment
What Are the Treatments Tested in This Trial?
Interventions
- Gemini
Find a Clinic Near You
Who Is Running the Clinical Trial?
Revelation Biosciences, Inc
Lead Sponsor