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Enzyme Replacement Therapy

ABO-101 for Primary Hyperoxaluria (redePHine Trial)

St. Paul, MN
Phase 1 & 2
Waitlist Available
Research Sponsored by Arbor Biotechnologies
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Age at time of signing the informed consent/assent form: Part A: ≥18 years to ≤64 years, Part B: ≥6 years to <18 years
Documentation of PH1 as determined by genetic analysis confirming pathogenic mutations in the alanine-glyoxylate aminotransferase (AGXT) gene (valid historical laboratory data will be reviewed and approved by the Sponsor)
Must not have
Confirmed diagnosis of primary hyperoxaluria type 2 or type 3
History of a liver, kidney or combined liver/kidney transplant
Timeline
Screening 3 weeks
Treatment Varies
Follow Up up to 5 years
Awards & highlights
No Placebo-Only Group

Summary

This trial is testing a medication called ABO-101 in people with primary hyperoxaluria type 1 (PH1) to see how safe and effective it is. The trial will have

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Who is the study for?
The redePHine study is for individuals with primary hyperoxaluria type 1 (PH1), a rare condition leading to kidney stones. Adults will first receive varying doses to find the best one, then children will be treated with that dose. Participants must meet certain health criteria not specified here.Check my eligibility
What is being tested?
ABO-101 is being tested in this trial. It's given in two parts: adults get different amounts at first, and once the right dose is found, kids get it too. Afterward, everyone enters a long-term monitoring phase to track safety and effects over time.See study design
What are the potential side effects?
Specific side effects of ABO-101 are not detailed here but generally could include reactions where the drug is administered, changes in blood tests or urine, fatigue, or other symptoms related to how the body tolerates ABO-101.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below
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I am 18-64 years old for Part A, or 6-17 years old for Part B.
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My genetic test shows a mutation in the AGXT gene, confirming PH1.
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Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:
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I have been diagnosed with primary hyperoxaluria type 2 or 3.
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I have had a liver, kidney, or liver/kidney transplant.
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I have used or am using RNAi or siRNA therapy for urinary oxalate reduction in the last 2 years.
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I am currently receiving dialysis.
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I am not pregnant, breastfeeding, nor planning to be in the next 12 months.
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Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~up to 5 years
This trial's timeline: 3 weeks for screening, Varies for treatment, and up to 5 years for reporting.

Treatment Details

Awards & Highlights

No Placebo-Only Group
All patients enrolled in this study will receive some form of active treatment.

Trial Design

2Treatment groups
Experimental Treatment
Group I: Experimental: Part B: Single Dose ExpansionExperimental Treatment1 Intervention
Group II: Experimental: Part A: Single Ascending Dose Escalation/Adaptive DesignExperimental Treatment1 Intervention

Find a Location

Closest Location:Nucleus Network· St. Paul, MN· 555 miles
Image of Nucleus Network in St. Paul, United States.Image of Nucleus Network in St. Paul, United States.Image of Nucleus Network in St. Paul, United States.

Who is running the clinical trial?

Arbor BiotechnologiesLead Sponsor
Winston Yan, MD, PhDStudy DirectorArbor Biotechnologies
~15 spots leftby Mar 2029
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