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

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ClinicalTrials.gov Identifier: NCT02000219
Recruitment Status : Active, not recruiting
First Posted : December 4, 2013
Last Update Posted : February 13, 2018
Sponsor:
Collaborator:
FP7-SME-2013 Research for the benefit of SMEs program
Information provided by (Responsible Party):
OxThera

Brief Summary:
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 or disease Intervention/treatment Phase
Primary Hyperoxaluria Biological: Oxalobacter formigenes Phase 2

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 8 participants
Intervention Model: Single Group Assignment
Masking: None (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
Actual Study Start Date : May 19, 2014
Estimated Primary Completion Date : February 2020
Estimated Study Completion Date : February 2020

Resource links provided by the National Library of Medicine

U.S. FDA Resources

Arm Intervention/treatment
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.

In Germany, the protocol has been amended such that patients can receive OC5 for a further 3 year of continued treatment after the initial part of the study.

Biological: Oxalobacter formigenes
The dose will be (not less than) NLT ≥1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner.
Other Names:
  • Oxabact
  • OC5



Primary Outcome Measures :
  1. Change in pre dialysis plasma oxalate level during treatment with OC5 compared with baseline. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the study) in the initial part of the study and then every month throughout the 3 year continued treatment period. ]

Secondary Outcome Measures :
  1. 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 initial part of the study) ]
  2. Change in number of O. formigenes in faeces during treatment with OC5. [ Time Frame: 6 weeks of active treatment (i.e. between Week 5 and Week 10 of the initial part of the study) and then every 2 months throughout the 3 year continued treatment period. ]
  3. Change in Speckle Tracking Echocardiography and traditional echocardiography from baseline. [ Time Frame: At baseline and approximately every 6 months throughout the 3 year continued treatment. ]
  4. Adverse events (AEs) [ Time Frame: 10 weeks (from week 5 to week 14 of the study) and throughout the 3 year continued treatment period. ]
  5. Hematology [ Time Frame: At baseline, Week 10 and 14 in the initial part of the study and then every month throughout the 3 year continued treatment period. ]
    Complete blood count with differential and platelet count will be evaluated.

  6. Clinical chemistry [ Time Frame: At baseline, Week 10 and 14 in the initial part of the study and then every month throughout the 3 year continued treatment period. ]
    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.

  7. Urinalysis [ Time Frame: At baseline, Week 10 and 14 in the initial part of the study and then every month throughout the 3 year continued treatment period. ]
    Protein, glucose and pH will be evaluated.



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

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.

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): NCT02000219


Locations
Germany
Universitätsklinikum Bonn, Department of Paediatric Nephrology
Bonn, Germany, DE-53113
Sponsors and Collaborators
OxThera
FP7-SME-2013 Research for the benefit of SMEs program
Investigators
Principal Investigator: Dawn Milliner, M.D. Mayo Clinic

Responsible Party: OxThera
ClinicalTrials.gov Identifier: NCT02000219     History of Changes
Other Study ID Numbers: OC5-OL-01
First Posted: December 4, 2013    Key Record Dates
Last Update Posted: February 13, 2018
Last Verified: February 2018

Keywords provided by OxThera:
hyperoxaluria
oxalate
PH
dialysis

Additional relevant MeSH terms:
Hyperoxaluria, Primary
Hyperoxaluria
Kidney Diseases
Urologic Diseases
Carbohydrate Metabolism, Inborn Errors
Metabolism, Inborn Errors
Genetic Diseases, Inborn
Metabolic Diseases