Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.
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Phase
Phase 1/2
Status
Completed
Study type
Interventional
Design
Randomized · Single · Treatment
Enrollment
40actual
Sites
3
Country
United States
Every value on this page is a field the sponsor filed with ClinicalTrials.gov, reproduced. Dates are their own estimates, revised as a study runs, unless the registry marks them actual. sources →
Source: ClinicalTrials.gov, retrieved 2026-08-19
Dates
each axis at the precision it was filed, with the registry's own basis| Date | Filed | Basis | What it is |
|---|---|---|---|
| Start | 2025-01-20 | actual | When the study began enrolling |
| Primary completion | 2025-07-22 | actual | The date the last participant is measured for the primary outcome — the readout window |
| Study completion | 2025-07-22 | actual | The whole study's end, after follow-up |
| First posted | 2025-03-07 | actual | When this record first appeared on the registry |
| Results posted | — | When the sponsor posted results to the registry | |
| Record updated | 2025-10-29 | actual | The sponsor's own last edit to this record — every projection above is as current as this date |
What it studies
Conditions
- Renal Insufficiency, Chronic
- Chronic Kidney Disease stage3
- Chronic Kidney Disease stage4
Interventions
- Drug: Intravenous Gemini — also filed as Phosphorylated hexaacylated disaccharide, PHAD
- Drug: Intravenous placebo — also filed as D5W
Primary outcomes
what the primary-completion date above is the date OFEffect of Gemini versus placebo on the incidence of treatment-emergent adverse events.
measured From time of dose to Day 8
Effect of Gemini vs placebo on electrical activity of the heart.
measured From time of dose to Day 8
Effect of Gemini versus placebo on blood pressure.
measured From time of dose to Day 8
Number of participants with abnormal laboratory hematology test results.
measured From time of dose to Day 8
Number of participants with abnormal laboratory chemistry tests results.
measured From time of dose to Day 8
Number of participants with abnormal laboratory urine tests results.
measured From time of dose to Day 8
Effect of Gemini versus placebo on inflammation in the body.
measured From time of dose to Day 8
Effect of Gemini versus placebo on inflammation.
measured From time of dose to Day 8
Effect of Gemini versus placebo on the inflammatory state of CKD subjects.
measured From time of dose to Day 8
Effect of Gemini versus placebo on kidney damage.
measured From time of dose to Day 8
Effect of Gemini versus placebo on heart rate.
measured From time of dose to Day 8
Effect of Gemini versus placebo on body temperature.
measured From time of dose to Day 8
Effect of Gemini versus placebo on respiration.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings.
measured From time of dose to Day 8
Number of participants with abnormal mental physical exam findings.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings above the shoulders.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the skin.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the heart.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the lungs.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the digestive system.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the body's support structure.
measured From time of dose to Day 8
Number of participants with abnormal physical exam findings of the nervous system.
measured From time of dose to Day 8
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