Actively Recruiting
Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
Led by Arbor Biotechnologies · Updated on 2026-02-12
23
Participants Needed
7
Research Sites
919 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 consist of 2 Study Periods. During the first Study Period, there will be 2 parts. In Part A, adult participants will be treated with a single ascending dose to identify a recommended dose. In Part B, pediatric participants will be treated with the recommended dose. Following the first Study Period, participants will start Study Period 2, a long-term monitoring program to comply with local and national requirements.
CONDITIONS
Official Title
Phase 1/2 Study of ABO-101 in Primary Hyperoxaluria Type 1 (redePHine)
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Documented PH1 diagnosis confirmed by genetic testing of the AGXT gene
- Age 18 to 64 years for adults (Part A)
- Age 6 to under 18 years for children (Part B)
- Urinary oxalate at or above 0.7 mmol/24 hours/1.73 m²
- Estimated glomerular filtration rate (eGFR) of 30 mL/min/1.73 m² or higher
- Body weight of at least 90 kg
You will not qualify if you...
- Diagnosed with primary hyperoxaluria type 2 or type 3
- History of liver, kidney, or combined liver/kidney transplant
- Currently receiving dialysis treatment
- Used or currently receiving approved or investigational RNAi or siRNA therapy for urinary oxalate lowering within past 24 months
- Female participants who are pregnant, breastfeeding, or planning pregnancy during first 12 months
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 7 locations
1
Mayo Clinic
Rochester, Minnesota, United States, 55905
Actively Recruiting
2
Nucleus Network
Saint Paul, Minnesota, United States, 55114
Withdrawn
3
Hospices Civils de Lyon- Hôpital Femmes Mères Enfants
Lyon, France
Not Yet Recruiting
4
Kindernierenzentrum Bonn
Bonn, Germany
Not Yet Recruiting
5
Heidi Chaker
Sfax, Tunisia
Actively Recruiting
6
Queen Elizabeth Hospital Birmingham
Birmingham, United Kingdom
Actively Recruiting
7
Royal Free Hospital
London, United Kingdom
Actively Recruiting
Research Team
D
Daniel Ory, MD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NON_RANDOMIZED
Model
SEQUENTIAL
Primary Purpose
TREATMENT
Number of Arms
2
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