URIROX-2: Establishing the Safety and Efficacy of Reloxaliase
Research type
Research Study
Full title
Establishing the Safety and Efficacy of Reloxaliase (Oxalate Decarboxylase) in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Double-blind, Placebo-Controlled Study (URIROX-2)
IRAS ID
265688
Contact name
Shabbir Moochhala
Contact email
Sponsor organisation
Allena Pharmaceuticals, Inc.
Eudract number
2018-000921-29
Duration of Study in the UK
4 years, 6 months, 28 days
Research summary
The ALLN-177-302 study is a randomised, double-blind, placebo-controlled study that will enroll patients with hyperoxaluria (a large amount of oxalate in the urine) that is caused by an underlying gastrointestinal condition that leads to absorption of too much oxalate from foods (enteric hyperoxaluria). Initially 400 participants will participate in the study across approximately 150 study centres globally.
The primary objectives of the study are to determine how well reloxaliase works in reducing urinary oxalate (UOx) excretion in patients with enteric hyperoxaluria, to evaluate the long term safety of reloxaliase, to evaluate the long term effect of treatment with reloxaliase on kidney stone disease progression and kidney function and to assess the impact of treatment with reloxaliase on burden of illness.
Study medication will be given on top of standard of care for this condition.
The total duration of participation will be minimally 27 months and maximum 63 months.The study is divided in 3 periods: screening period (2 months), treatment period (min 24, max 60 months) and a follow-up period (4 weeks). During the treatment period the participants will self-administer study medication/placebo orally, 2 capsules 3 to 5 times/day (6 to 10 capsules in total/day) with food.
Once ingested with food, reloxaliase degrades dietary oxalate or oxalate secreted along the GI tract, resulting in decreased oxalate available for absorption into the systemic circulation, and subsequently reduced UOx excretion.
If a participant stops taking the study medication before the minimum treatment duration is completed, the participant will be asked to join the observation arm of the study. In this observation arm no study medication needs to be taken but participants will be asked to come to the study centre on a modified visit schedule for further follow-up.
REC name
London - London Bridge Research Ethics Committee
REC reference
19/LO/1904
Date of REC Opinion
28 Jan 2020
REC opinion
Further Information Favourable Opinion