COMPLETED

Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.

Conditions

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

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Study Overview

This clinical trial focuses on testing the efficacy of different digital interventions to promote re-engagement in cancer-related long-term follow-up care for adolescent and young adult (AYA) survivors of childhood cancer.

Description

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.

Official Title

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

Quick Facts

Study Start:2025-01-20

Study Completion:2025-07-22

Study Type:Not specified

Phase:Not Applicable

Enrollment:Not specified

Status:COMPLETED

Study ID

NCT06863467

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Ages Eligible for Study:18 Years to 80 Years

Sexes Eligible for Study:ALL

Accepts Healthy Volunteers:No

Standard Ages:ADULT, OLDER_ADULT

Inclusion Criteria	Exclusion 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	* 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

Inclusion Criteria

Exclusion 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

* 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

Contacts and Locations

Principal Investigator

Chief Executive Officer

STUDY_DIRECTOR

Revelation Biosciences, Inc

Study Locations (Sites)

California Institute of Renal Research

Chula Vista, California, 91911

United States

California Institute of Renal Research

La Mesa, California, 92942

United States

Clinical Advance Center, PLLC

San Antonio, Texas, 78212

United States

Collaborators and Investigators

Sponsor: Revelation Biosciences, Inc

Chief Executive Officer, STUDY_DIRECTOR, Revelation Biosciences, Inc

Study Record Dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Registration Dates

Study Start Date2025-01-20

Study Completion Date2025-07-22

Study Record Updates

Study Start Date2025-01-20

Study Completion Date2025-07-22

Terms related to this study

Additional Relevant MeSH Terms

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