Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.
Completed · Phase 1/Phase 2 · Has a placebo group
Conditions studied: Renal Insufficiency, Chronic, Chronic Kidney Disease stage3, Chronic Kidney Disease stage4
In brief
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.
Key facts
- Study ID
- NCT06863467
- Run by
- Revelation Biosciences, Inc
- People needed
- 40
- Starts
- 2025-01-20
- Expected to finish
- 2025-07-22
- Last updated by the study team
- 2025-10-29
Who can join
Age: 18 and older, up to 80. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- CKD Secondary to or associated with any of the following:
- History of rapidly progressive glomerulonephritis (RPGN)
- 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)
Where it is running
- California Institute of Renal Research — Chula Vista, California, United States
- California Institute of Renal Research — La Mesa, California, United States
- Clinical Advance Center, PLLC — San Antonio, Texas, United States
Full record on ClinicalTrials.gov
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