Status:

RECRUITING

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

Lead Sponsor:

Arbor Biotechnologies

Conditions:

Primary Hyperoxaluria Type 1 (PH1)

Eligibility:

All Genders

6-64 years

Phase:

PHASE1

PHASE2

Brief Summary

The goal of the redePHine study is to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ABO-101 in participants with primary hyperoxaluria type 1 (PH1). The trial will consi...

Eligibility Criteria

Key Inclusion Criteria for Parts A and B

  • 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

Key Exclusion Criteria for Parts A and B

  • 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)

Key Trial Info

Start Date :

June 16 2025

Trial Type :

INTERVENTIONAL

Allocation :

ESTIMATED

End Date :

February 1 2043

Estimated Enrollment :

23 Patients enrolled

Trial Details

Trial ID

NCT06839235

Start Date

June 16 2025

End Date

February 1 2043

Last Update

February 12 2026

Active Locations (7)

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Page 1 of 2 (7 locations)

1

Mayo Clinic

Rochester, Minnesota, United States, 55905

2

Nucleus Network

Saint Paul, Minnesota, United States, 55114

3

Hospices Civils de Lyon- Hôpital Femmes Mères Enfants

Lyon, France

4

Kindernierenzentrum Bonn

Bonn, Germany