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)
Enter a location and click search to find clinical trials sorted by distance.
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