Evaluate the Safety and Efficacy of ALLN-177 (oxalate decarboxylase)
Research type
Research Study
Full title
Evaluate the Safety and Efficacy of ALLN-177 in Patients with Enteric Hyperoxaluria: A Phase III Randomized, Placebo-Controlled Study
IRAS ID
245158
Contact name
Shabbir Hatim Moochhala
Contact email
Sponsor organisation
Allena Pharmaceuticals, Inc.
Eudract number
2017-004352-33
Duration of Study in the UK
1 years, 2 months, 0 days
Research summary
The study will enrol participants with hyperoxaluria (a large amount of oxalate in urine) that is caused by an underlying gastrointestinal condition that leads to absorption of too much oxalate from foods (enteric hyperoxaluria). Examples of such conditions are: Crohn’s disease and other inflammatory bowel diseases; after gastric bypass surgery or surgery to remove a section of the intestine; disorders of the pancreas due to cystic fibrosis or pancreatitis; and other conditions that lead to abnormal absorption. Approximately 124 participants will be randomised and enrolment is anticipated to occur at approximately 75 sites, globally.
The proposed study is a randomised, double-blind, placebo-controlled trial in participants with eneteric HOx. The double-blind placebo-controlled design enables the most objective assessment of the efficacy and safety of ALLN-177. A placebo comparator (in addition to standard of care) is appropriate, given that there are no approved pharmacological therapies for treating HOx.
Total duration of study participation per participant will be approximately 12 weeks, divided into 3 study periods: 4-week Screening Period, 4-week Treatment Period and a 4-week Follow-up Period.
During the treatment phase of the study, participants will self-administer 2 capsules of either ALLN-177 or placebo with each meal/snack, 3 to 5 times per day (6-10 capsules per day) for a total of 28 days.
Once ingested with food, ALLN-177 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. The ultimate long-term aims of reducing oxalate absorption and UOx levels are to decrease CaOx precipitation and kidney stone formation, as well as systemic (renal and other tissue) oxalate deposition.
The primary objectives of this study are to determine the efficacy of ALLN-177 in reducing UOx excretion in participants with enteric HOx and evaluate the safety of ALLN-177 in participants with enteric HOx.
REC name
London - Brent Research Ethics Committee
REC reference
18/LO/1358
Date of REC Opinion
29 Oct 2018
REC opinion
Further Information Favourable Opinion