Evaluating the safety of Gemini in patients with advanced chronic kidney disease

A Phase 1b, Randomized, Placebo-Controlled, Single-Blind, Single Ascending Dose Study in Subjects With Stage 3 or 4 Chronic Kidney Disease

This study is testing if an intravenous drug called Gemini is safe for adults with advanced chronic kidney disease.

Quick facts

• Phase: PHASE1; PHASE2
• Study type: Interventional
• Enrollment: 40 (estimated)
• Ages: 18 Years to 80 Years
• Sex: All
• Sponsor: Revelation Biosciences, Inc (industry)
• Locations: 3 sites (Chula Vista, California and 2 other locations)
• Trial ID: NCT06863467 on ClinicalTrials.gov

What this trial studies

This study evaluates the safety and tolerability of intravenous Gemini in adults with stage 3 or 4 chronic kidney disease through a randomized, placebo-controlled, single-blind, single-ascending dose design. Up to 40 subjects will be enrolled across five cohorts, with each cohort receiving a single IV dose of Gemini or placebo. The study will assess pharmacokinetics and pharmacodynamic markers to determine the drug's effects and safety profile. A Safety Review Committee will monitor adverse events and decide on dose escalation based on safety data.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 80 with stage 3 or 4 chronic kidney disease and an eGFR between 15 and 60.

Not a fit: Patients with chronic kidney disease secondary to rapidly progressive glomerulonephritis or those currently on specific medications may not benefit from this study.

Why it matters

Potential benefit: If successful, this study could lead to a new treatment option for patients with advanced chronic kidney disease.

How similar studies have performed: While this approach is novel, similar studies evaluating safety and tolerability of new treatments in chronic kidney disease have shown promise.

Eligibility criteria

Inclusion Criteria:

* Male or female subjects ≥18 to ≤ 80 years of age at screening
* Willing and able to provide written informed consent
* eGFR of ≥ 15 and ≤ 60 per
* Female subjects must be of non-childbearing potential or using a medically acceptable contraceptive regimen
* Male subjects must be surgically sterile or using a medically acceptable contraceptive regimen
* Willing and able to tolerate IV infusions and multiple blood draws
* Willing to comply with the study schedule, restrictions, and requirements

Exclusion Criteria:

* CKD Secondary to or associated with any of the following:

  1. History of rapidly progressive glomerulonephritis (RPGN)
  2. Glomerulonephritis requiring any use of immunosuppression in the last 6 months
* Body mass index ≤ 19.0 kg/m2 or ≥ 40.0 kg/m2
* Currently taking a sodium/glucose cotransporter-2 inhibitor (SGLT2i) or non-steroidal mineralocorticoidantagonist (MRA) requiring dose adjustments within 12 weeks prior to Day 1 or if dose is anticipated to change
* Currently taking tumor necrosis factor (TNF) inhibitors, TNF blocker, interleukin-6 (IL-6) blockers or interleukin-1 (IL-1) blocking drugs
* Receiving steroids or any other immunosuppressive agent or anti-inflammatory drugs
* Currently taking an angiotensin-converting enzyme inhibitor (ACEi) and/or an angiotensin II receptor blocker (ARB) requiring dose adjustments
* Any use of direct renin inhibitors;
* Live vaccinations within 3 months prior to the start of the trial or expected during the trial
* Received a mRNA vaccine within 4 weeks
* Uncontrolled diabetes (HbA1c \> 11.0%)
* Clinical laboratory results of ALT and/or AST that are \> 2.5X upper limit of normal (ULN)
* Clinical Laboratory results of Total bilirubin that is \> 1.5X the ULN
* Has a Urine Albumin-to-Creatinine Ratio (uACR) level \> 3000 mg/g
* Age-related macular degeneration (AMD), diabetic macular edema or active diabetic proliferative retinopathy that was likely to require treatment during the trial
* Uncontrolled hypertension
* New York Heart Association Class IV congestive heart failure
* Any organ transplant recipient, or a planned transplant during the study
* Currently has known Hepatitis B or uncontrolled human immunodeficiency virus (HIV) or uncontrolled Hepatitis C virus (HCV) that may interfere with the study
* Myocardial infarction, acute coronary syndrome, or stroke within 6 months
* History of myelodysplastic syndrome
* History of deep vein thrombosis (DVT) that required active treatment in the last 6 months. Superficial thrombosis is not excluded
* History of hemosiderosis or hemochromatosis
* History of rheumatoid arthritis or systemic lupus erythematosus (SLE)
* History of drug use that may interfere with the study or study result
* Red cell transfusion within 12 weeks
* History of malignancy in the previous 5 years except for curatively resected basal cell carcinoma of skin, squamous cell carcinoma of skin or cervical carcinoma in situ
* Coronavirus disease 2019 (COVID-19) diagnosis within 1 month
* Evidence of active infection unless subject is appropriate for this study per the Investigator
* Life expectancy less than 6 months
* Intolerance to study medication
* Pregnancy or lactation
* Received treatment with any investigational product in any clinical study within 30 days prior to administration of study drug or five half-lives, whichever is longer
* In the opinion of the Investigator or identified Sub-I(s), any other disease processes or confounding variables that would inappropriately alter the outcome of the study

Where this trial is running

Chula Vista, California and 2 other locations

• California Institute of Renal Research — Chula Vista, California, United States (RECRUITING)
• California Institute of Renal Research — La Mesa, California, United States (RECRUITING)
• Clinical Advance Center, PLLC — San Antonio, Texas, United States (RECRUITING)

Study contacts

• Study coordinator: Vice President, Clinical Operations

Conditions: Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4