A phase III study of Oxabact® in patients with primary hyperoxaluria
Research type
Research Study
Full title
A phase III double-blind, randomised study to evaluate the long-term efficacy and safety of Oxabact® in patients with primary hyperoxaluria
IRAS ID
222734
Contact name
Shabbir Moochhala
Contact email
Sponsor organisation
OxThera Intellectual Property AB
Eudract number
2017-000684-33
Duration of Study in the UK
2 years, 6 months, 0 days
Research summary
This research is investigating a new medicine to potentially treat Primary Hyperoxaluria that is also known as PH. PH is a genetic (having to do with origin, birth) disease that causes the body to make too much of a substance called oxalate. PH can cause patients to have large amounts of oxalate in their blood and urine, which means that they are more likely to have kidney stones or calcium oxalate crystals in their kidneys. This can cause damage to the kidney(s).
This research will investigate whether taking a new medicine called Oxabact® (OC5) can reduce the amount of oxalate in the blood and/or improve the function of the kidney in children and adults with PH
The primary objective of OC5-DB-02 study is to evaluate the efficacy of Oxabact® (OC5) to reduce plasma oxalate levels during 52 weeks in subjects with PH. The study will also evaluate effects on kidney function and myocardial function (related to decreased oxalate crystal deposits in the heart). Eighteen subjects, aged 2 years and over, will be included in the study and randomised 1:1 to either OC5 or placebo. The study will be conducted at 8-10 sites in five countries, Germany, France, the United Kingdom, the Netherlands and the United States.
REC name
East of Scotland Research Ethics Service REC 2
REC reference
17/ES/0108
Date of REC Opinion
11 Aug 2017
REC opinion
Unfavourable Opinion