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Phase 1/2 Study of ABO-101 for Primary Hyperoxaluria Type 1 (redePHine)

This study, called redePHine, is testing a drug called ABO-101 for people with Primary Hyperoxaluria Type 1 (PH1), a genetic kidney disorder. The main goal is to see how safe ABO-101 is and if it causes any side effects. Researchers will also look at how the body handles the drug and how it affects the disease. You may be able to join if you are between 6 and 64 years old and have a confirmed diagnosis of PH1 through genetic testing. The study will first test different doses in adults to find the best one, then give that dose to children. The study status is currently unclear.

Study design
This is an interventional study planning to enroll 23 participants. It has two main periods, with the first period having two parts: one for adults and one for children.
What's involved
Not specified in the trial record.
Compensation
Not stated in the trial record.
Follow-up
Participants will be monitored for safety for up to 6 months after treatment, followed by a long-term monitoring program.

AI-generated from the public study record. Only the study team can confirm whether you're eligible — confirm details with them before making decisions.

NCT06839235

Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)

Recruiting
PHASE1Ages 6–64InterventionalTreatment
Arbor Biotechnologies
~23 participants
Updated 2026-02-12 on ClinicalTrials.gov
What's tested:ABO-101

At a glance

Recruiting sites
4 of 7 listed sites are recruiting right now
RecruitingSuspended, closed, or not yet open
What they're measuring
Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101-related TEAEs and serious adverse events (SAEs)
Measured over Up to 6 months

Conditions

Primary Hyperoxaluria Type 1 (PH1)

Explore related trials

Primary Hyperoxaluria Type IAGXT Gene

Where it's being run

7 sites across 5 states
Minnesota2
United Kingdom2
France1
Germany1
Tunisia1

Study leadership

  • Winston Yan, MD, PhD · STUDY_DIRECTOR · Arbor Biotechnologies

Who to contact

Daniel Ory, MD
[email protected]
617-500-8941
Email the study team

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Do you actually qualify for this trial?

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Eligibility criteria

Inclusion

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)
Age at time of signing the informed consent/assent form:
Part A: ≥18 years to ≤64 years
Part B: ≥6 years to \<18 years
24-hour UOx ≥0.7 mmol/24 hours/1.73 m²
eGFR ≥30 mL/min/1.73m²
Weight ≤90 kg

Exclusion

Confirmed diagnosis of primary hyperoxaluria type 2 or type 3
History of a liver, kidney or combined liver/kidney transplant
Currently on dialysis
Participant has previously used (within past 24 months) or is currently receiving an approved or investigational urinary oxalate lowering RNA interference (RNAi) or siRNA therapy
Female participants who are pregnant or breastfeeding (or are planning either during the first 12 months)

What this trial measures

  • Incidence and severity of treatment-emergent adverse events (TEAEs), including ABO-101-related TEAEs and serious adverse events (SAEs)Up to 6 months