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A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03116685
Recruitment Status : Completed
First Posted : April 17, 2017
Results First Posted : December 9, 2021
Last Update Posted : December 10, 2021
Information provided by (Responsible Party):

Brief Summary:
This study will evaluate the efficacy and safety of OC5 in patients with PH.

Condition or disease Intervention/treatment Phase
Primary Hyperoxaluria Biological: Oxabact OC5 - Oxalobacter formigenes HC-1 Other: Placebo Phase 3

Detailed Description:
To evaluate the efficacy of Oxabact following 52 weeks treatment in subjects with maintained kidney function, but below the lower limit of the normal range (estimated glomerular filtration rate [eGFR] < 90 ml/min/1.73 m2) and a total plasma oxalate (Pox) concentration ≥ 10 μmol/L. Parameters to be evaluated include the ability to stabilise/reduce Pox concentration, to stabilise/improve kidney function and to reduce oxalate deposits in primary hyperoxaluria (PH) subjects.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 25 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Actual Study Start Date : January 9, 2018
Actual Primary Completion Date : April 15, 2021
Actual Study Completion Date : April 15, 2021

Resource links provided by the National Library of Medicine

Arm Intervention/treatment
Experimental: Oxabact OC5 capsules
Oxabact OC5 - Oxalobacter formigenes HC-1
Biological: Oxabact OC5 - Oxalobacter formigenes HC-1
Active study drug

Placebo Comparator: Placebo capsules
Other: Placebo

Primary Outcome Measures :
  1. Change From Baseline in Plasma Oxalate Concentration After 52 Weeks of Treatment [ Time Frame: 52 weeks ]
    Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter

Secondary Outcome Measures :
  1. Change From Baseline in Kidney Function [ Time Frame: 52 weeks ]
    Evaluation based on eGFR calculation using the 2009 creatinine-based "Schwartz bedside" equation (for children below 18 years of age) (Schwartz et al., 2009) and 2009 creatinine-based CKD-EPI equation for adults (Levey et al., 2009). Subjects who turn 18 during the study period were continuously evaluated using the Schwartz equation, ie the equation used at baseline was kept throughout the study.

  2. Frequency of Kidney Stone Events [ Time Frame: Through week 48 ]
    Number of kidney stone events for each patient

Information from the National Library of Medicine

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Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed informed consent (as applicable for the age of the subject)
  2. A diagnosis of PH (as determined by standard diagnostic methods).
  3. eGFR < 90 ml/min/1.73 m2. The Schwartz formula will be used to estimate GFR for children (age below 18), and CKD-EPI formula will be used for adults (age 18 or above).
  4. Plasma oxalate concentration ≥10 μmol/L in total plasma oxalate.
  5. Male or female patients ≥ 2 years of age.
  6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must not change the dose during the study. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria:

  1. Inability to swallow size 4 capsules.
  2. Subjects that have undergone transplantation (solid organ or bone marrow).
  3. Patients requiring dialysis or at immediate risk for kidney failure or expected to be in need of dialysis during the study period.
  4. The existence of secondary hyperoxaluria, e.g. hyperoxaluria due to bariatric surgery or chronic gastrointestinal diseases such as cystic fibrosis, chronic inflammatory bowel disease and short-bowel syndrome.
  5. Use of antibiotics to which O. formigenes is sensitive. (This includes current antibiotic use, or antibiotics use within 14 days of initiating study medication).
  6. Current treatment with a separate ascorbic acid preparation.
  7. Pregnant women (or women who are planning to become pregnant) or lactating women.
  8. Women of childbearing potential who are not using adequate contraceptive precautions. Please see section 7.3 regarding requirements for contraception.
  9. Presence of a medical condition that the Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures or any condition that is likely to interfere with the study drug mechanism of action (such as abnormal GI function).
  10. Participation in any interventional study of another investigational product, biologic, device, or other agent within 60 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03116685

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United States, Tennessee
Vanderbilt University Hospital
Nashville, Tennessee, United States, 37232
Centre Hospitalier Universitaire de Liège
Liège, Belgium
Hôpital Robert Debré
Paris, France, 75019
Kindernierenzentrum Bonn
Bonn, Germany, 53127
Hospital Vall d' Hebron
Barcelona, Spain
Hédi Chaker University Hospital
Sfax, Tunisia, 3000
Sahloul University Hospital
Sousse, Tunisia, 4054
Charles Nicolle University Hospital
Tunis, Tunisia, 1008
United Kingdom
Royal Free Hospital
London, United Kingdom, NW3 2QG
Nottingham Children's Hospital
Nottingham, United Kingdom, NG7 2UH
Sponsors and Collaborators
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Principal Investigator: Gesa Schalk, MD KindernierenZentrum, Bonn, Germany
  Study Documents (Full-Text)

Documents provided by OxThera:
Study Protocol  [PDF] January 8, 2021
Statistical Analysis Plan  [PDF] February 8, 2021

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Responsible Party: OxThera
ClinicalTrials.gov Identifier: NCT03116685    
Other Study ID Numbers: OC5-DB-02
First Posted: April 17, 2017    Key Record Dates
Results First Posted: December 9, 2021
Last Update Posted: December 10, 2021
Last Verified: October 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Hyperoxaluria, Primary
Kidney Diseases
Urologic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases