Try our beta test site
IMPORTANT: Listing of a study on this site does not reflect endorsement by the National Institutes of Health. Talk with a trusted healthcare professional before volunteering for a study. Read more...

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis

This study is currently recruiting participants. (see Contacts and Locations)
Verified September 2016 by OxThera
FP7-SME-2013 Research for the benefit of SMEs program
Information provided by (Responsible Party):
OxThera Identifier:
First received: November 20, 2013
Last updated: September 26, 2016
Last verified: September 2016
The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.

Condition Intervention Phase
Primary Hyperoxaluria
Biological: Oxalobacter formigenes
Phase 2

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: A Phase 2 Open-label Multi-centre Study to Evaluate the Efficacy and Safety of Oxabact® to Reduce Plasma Oxalate in Subjects With Primary Hyperoxaluria Who Are on Dialysis

Resource links provided by NLM:

Further study details as provided by OxThera:

Primary Outcome Measures:
  • Change in pre dialysis plasma oxalate level after 6 weeks of treatment, compared with baseline. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]

Secondary Outcome Measures:
  • Change in pre-dialysis plasma oxalate levels during 6 weeks of treatment in subsets of subjects defined by dialysis regimen (HD or PD). [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
  • Duration of efficacy measured by pre dialysis plasma oxalate values from week 10 to week 14, following termination of OC5 treatment. [ Time Frame: 4 weeks after treatment (i.e. between Week 10 and Wk 14 of the study) ]
  • Change in number of O. formigenes in faeces during 6 weeks of treatment. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
  • Change in total oxalate removal by dialysis and urinary clearance during 6 weeks of treatment in a limited number of subjects participating in the sub-study. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) ]
    Sub-study only to be performed in the patients from the Mayo Clinic.

  • Adverse events (AEs) [ Time Frame: 10 weeks (from week 5 to week 14 of the study) ]
  • Hematology [ Time Frame: 14 weeks (throughout the entire study) ]
    Blood samples taken for hematology at weeks 0, 4, 10 and 14. Complete blood count with differential and platelet count will be evaluated.

  • Clinical chemistry [ Time Frame: 14 weeks (throughout the entire study) ]
    Blood samples taken for clinical chemistry at weeks 0, 4, 10 and 14 of the study. Blood Urea Nitrogen, creatinine, electrolytes (Na+, K+, Mg++, Ca++, HCO3+, Cl), glucose, pH, albumin, alkaline phosphatase, ALT, AST, total bilirubin, and total protein will be evaluated.

  • Urinalysis [ Time Frame: 14 weeks (throughout the entire study) ]
    Urine samples will be taken at weeks 0, 4, 10 and 14 of the study. Protein, glucose and pH will be evaluated.

Estimated Enrollment: 8
Study Start Date: May 2014
Estimated Study Completion Date: December 2018
Estimated Primary Completion Date: December 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxabact OC5 capsule
This is an open-label study so all patients will receive the active drug product, Oxalobacter formigenes, OC5. This will be administered as an enteric-coated capsules twice daily for 6 weeks of treatment.
Biological: Oxalobacter formigenes
The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily for 6 weeks. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner
Other Names:
  • Oxabact
  • OC5


Ages Eligible for Study:   Child, Adult, Senior
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  1. Signed informed consent (as applicable for the age of the subject). A separate appendix to the informed consent will be signed by patients who will participate in the sub-study.
  2. Male or female subjects ≥ 2 years of age. Subjects have to be able to swallow size 4 capsules twice daily for 6 weeks, or use a gastric tube that allows for administration of size 4 capsules.
  3. A diagnosis of PH (as determined by standard diagnostic methods).
  4. Patient should be on a stable dialysis regimen for at least two weeks before baseline.
  5. Pre-dialysis plasma oxalate ≥40 micromole/L.
  6. Subjects receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must remain on the stable dose during the study. Subjects not receiving vitamin B6 at study entry must be willing to refrain from initiating vitamin B6 during study participation.

    Exclusion Criteria:

  7. Inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube not suited for administration of size 4 capsules via the tube.
  8. Ongoing treatment with immunosuppressive medication.
  9. 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.
  10. Use of antibiotics to which O. formigenes is sensitive (see section 7.2.2), including current antibiotic use, or antibiotics use within 14 days of initiating study medication.
  11. Current treatment with a separate ascorbic acid preparation.
  12. Pregnancy.
  13. Women of childbearing potential who are not using adequate contraceptive precautions. Sexually active females, unless surgically sterile or at least 2 years post-menopausal, must be using a highly effective contraception (including oral, transdermal, injectable, or implanted contraceptives, IUD, abstinence, use of a condom by the sexual partner or sterile sexual partner) for 30 days prior to the first dose of OC5 and must agree to continue using such precautions during the clinical study.
  14. Presence of a medical condition that the Principal Investigator considers likely to make the subject susceptible to adverse effect of study treatment or unable to follow study procedures.
  15. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.
  Contacts and Locations
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT02000219

Contact: Anna Sjögren 0046 8 660 0223
Contact: Orla Mc Callion, BSc PhD 0046 8 660 0223

United States, Minnesota
Mayo Clinic (Division of Nephrology) Recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamara Evans    507-284-1004   
Principal Investigator: Dawn Milliner, M.D.         
Hôpital Femme Mère Enfant, Lyon; Paediatric Department Recruiting
Lyon, Bron cedex, France, 69677
Principal Investigator: Anne-Laure Sellier-Leclerc, M.D.         
Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest Recruiting
Bordeaux, France, 33076
Principal Investigator: Jérôme Harambat, MD         
Universitätsklinikum Bonn, Department of Paediatric Nephrology Recruiting
Bonn, Germany, DE-53113
Principal Investigator: Bernd Hoppe, M.D.         
Sponsors and Collaborators
FP7-SME-2013 Research for the benefit of SMEs program
Principal Investigator: Dawn Milliner, M.D. Mayo Clinic
  More Information

Responsible Party: OxThera Identifier: NCT02000219     History of Changes
Other Study ID Numbers: OC5-OL-01
Study First Received: November 20, 2013
Last Updated: September 26, 2016

Keywords provided by OxThera:

Additional relevant MeSH terms:
Hyperoxaluria, Primary
Kidney Diseases
Urologic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases processed this record on May 25, 2017