Gemini for Chronic Kidney Disease (PRIME Trial)

Recruiting in Palo Alto (17 mi)

+2 other locations

Age: 18+

Sex: Any

Travel: May be covered

Time Reimbursement: Varies

Trial Phase: Phase 1 & 2

Recruiting

Sponsor: Revelation Biosciences, Inc

No Placebo Group

Trial Summary

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.

Eligibility Criteria

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

I am either not able to have children or I am using birth control.

I am between 18 and 80 years old.

My kidney function is low but not in kidney failure.

I am a man who is either surgically sterile or using birth control.

Exclusion Criteria

I am currently taking steroids or other drugs that suppress my immune system.

I am on ACE inhibitors or ARBs and my dose needs adjusting.

My BMI is either below 19 or above 40.

I am on SGLT2i or MRA medication and my dose changed recently or might change soon.

I am currently on medication that targets inflammation.

I received an mRNA vaccine in the last 4 weeks.

My diabetes is not under control (HbA1c > 11.0%).

I have a serious eye condition that may need treatment during the trial.

My blood pressure is not well-controlled.

I have had an organ transplant or plan to have one during the study.

I have a history of myelodysplastic syndrome.

I have a history of iron overload in my body.

I have a history of rheumatoid arthritis or lupus.

I have used medication that directly inhibits renin.

I have not received any live vaccines in the last 3 months.

I have the most severe form of heart failure.

Participant Groups

The trial is testing Gemini, a new drug given through the veins. Participants will either get Gemini or a placebo in one dose, and doctors will watch how safe it is and how the body responds to it.

4Treatment groups

Experimental Treatment

Group I: Optional High dose of intravenous Gemini infused once over 10-15 minutes.Experimental Treatment2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group II: Mid-level dose of intravenous Gemini infused once over 10-15 minutes.Experimental Treatment2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group III: Low dose of intravenous Gemini infused once over 10-15 minutes.Experimental Treatment2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)

Group IV: High dose of intravenous Gemini infused once over 10-15 minutes.Experimental Treatment2 Interventions

Cohort 1, 8 subjects (6 active, 2 placebo)