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NCT06721143 · ClinicalTrials.gov registry record · Phase 1
A Study to Investigate the Safety, Tolerability, and Preliminary Efficacy with AION-301 Administered by Intravenous Infusion Compared with Placebo Administered by Intravenous Infusion Investigational Intervention in Participants Aged 35 to 75 Years of Age with Chronic Kidney Disease (CKD)
A Phase 1 study of Chronic Kidney Disease Stage 3, sponsored by AION Healthspan.
- Recruiting
- Registry status
- Phase 1
- Development phase
- 36
- Enrollment target
- 1
- Study location
NCT06721143 is a Phase 1 study of Chronic Kidney Disease Stage 3 that is actively recruiting participants, run by AION Healthspan. The registered enrollment target is 36 participants, below the 7,447-participant average among 3 other Chronic Kidney Disease Stage 3 trials with a reported enrollment target (100% lower). The trial reports 1 study location across 1 state.
The verdict
NCT06721143, a Phase 1 study of Chronic Kidney Disease Stage 3, is actively recruiting participants, sponsored by AION Healthspan.
- RECRUITING
- Registry status
- Phase 1
- Development phase
- 36 participants
- Enrollment target
- 1
- Study location
Study Summary
The goal of this clinical trial is to learn about the safety (good or bad) of giving two AION-301 intravenous (IV) infusions, in adults with Stage 3 Chronic Kidney Disease (CKD). It will also help to learn if AION-301 reduces the symptoms of CKD and/or progression. The main questions it aims to answer are: * Do participants have medical problems (adverse events) after receiving two infusions of AION-301? * Do participants feel better (have reduced and/or delayed CKD symptoms)? * To learn about how AION-301 works in participants with CKD? Researchers will compare AION-301 to a placebo (a look-alike substance that contains no drug) to see if AION-301 works to treat Stage 3 CKD. Participants will: * Receive two infusions of AION-301 or placebo on two separate days (Day 0 and Day 4). * Receive oral vitamins at the clinic and to take at home for 90 days. * Visit the clinic for a minimum of 9 times, over 6 months for checkups and tests, but could be up to 12 times, over 24 months for checkups and tests.
Conditions Studied
Interventions
- DRUG Placebo
- BIOLOGICAL AION-301
Study Locations (1)
Florida
- University of Miami, Leonard M. Miller School of Medicine - Miami
Trial Details
| Field | Value |
|---|---|
| Enrollment Target | 36 participants |
| Start Date | 2025-01-23 |
| Est. Completion | 2027-12 |
| Phase | Phase 1 |
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Full Details on ClinicalTrials.gov ↗What the Registry Record Tells You About NCT06721143
The ClinicalTrials.gov registry entry for NCT06721143 describes a study currently listed as recruiting, categorized as Phase 1. The registered enrollment target is 36 participants, a figure that helps gauge the scale of data the investigators plan to collect, below the 7,447-participant average among 3 other Chronic Kidney Disease Stage 3 trials with a reported enrollment target (100% lower). The listed sponsor is AION Healthspan, which has 1 total studies on file at ClinicalTrials.gov.
The record links to 1 condition, with Chronic Kidney Disease Stage 3 appearing as the primary indexed condition, and to 2 interventions - of which Placebo is the first listed.
NCT06721143 reports 1 study location spanning 1 distinct geographic area - top geographies include Florida.
Frequently Asked Questions
What is clinical trial NCT06721143 about?
NCT06721143 is a clinical study titled "A Study to Investigate the Safety, Tolerability, and Preliminary Efficacy with AION-301 Administered by Intravenous Infusion Compared with Placebo Administered by Intravenous Infusion Investigational Intervention in Participants Aged 35 to 75 Years of Age with Chronic Kidney Disease (CKD)". The goal of this clinical trial is to learn about the safety (good or bad) of giving two AION-301 intravenous (IV) infusions, in adults with Stage 3 Chronic Kidney Disease (CKD). It will also help to learn if AION-301 reduces the symptoms of CKD and/or progression. The main questions it aims to answ...
What is the current status of trial NCT06721143?
This trial is currently recruiting. It is a Phase 1 study. The enrollment target is 36 participants. The study started on 2025-01-23. Estimated completion is 2027-12.
What conditions does trial NCT06721143 study?
This clinical trial studies the following conditions: Chronic Kidney Disease Stage 3.
What interventions are being tested in trial NCT06721143?
The interventions under investigation include: Placebo (DRUG), AION-301 (BIOLOGICAL).
Who is sponsoring clinical trial NCT06721143?
This trial is sponsored by AION Healthspan, which has 1 total clinical trials registered on ClinicalTrials.gov.
Where is trial NCT06721143 being conducted?
This trial has 1 study location across Florida. Contact the study sites directly through ClinicalTrials.gov for enrollment availability.
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