Trial record 5 of 13 for:    "primary hyperoxaluria"

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

This study is not yet open for participant recruitment. (see Contacts and Locations)
Verified November 2013 by OxThera
Sponsor:
Collaborator:
FP7-SME-2013 Research for the benefit of SMEs program
Information provided by (Responsible Party):
OxThera
ClinicalTrials.gov Identifier:
NCT02000219
First received: November 20, 2013
Last updated: November 26, 2013
Last verified: November 2013
  Purpose

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: Endpoint Classification: Safety/Efficacy Study
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) ] [ Designated as safety issue: No ]

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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
  • 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) ] [ Designated as safety issue: No ]
    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) ] [ Designated as safety issue: Yes ]
  • Hematology [ Time Frame: 14 weeks (throughout the entire study) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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) ] [ Designated as safety issue: Yes ]
    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: February 2014
Estimated Study Completion Date: September 2014
Estimated Primary Completion Date: September 2014 (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

  Eligibility

Genders Eligible for Study:   Both
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. A diagnosis of PH (as determined by standard diagnostic methods).
  3. Patient should be on a stable dialysis regimen for at least two weeks before baseline.
  4. Pre-dialysis plasma oxalate ≥40 micromole/L.
  5. Subjects receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to entry into the study 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:

  6. Ongoing treatment with immunosuppressive medication.
  7. 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.
  8. 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.
  9. Current treatment with a separate ascorbic acid preparation.
  10. Pregnancy.
  11. 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.
  12. 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.
  13. 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 ClinicalTrials.gov identifier: NCT02000219

Contacts
Contact: Anna Sjögren 0046 8 660 0223 anna.sjogren@oxthera.com
Contact: Orla Mc Callion, BSc PhD 0046 8 660 0223 orla.mccallion@oxthera.com

Locations
United States, Minnesota
Mayo Clinic (Division of Nephrology) Not yet recruiting
Rochester, Minnesota, United States, 55905
Contact: Tamara Evans    507-284-1004    evans.tamara@mayo.edu   
Principal Investigator: Dawn Milliner, M.D.         
France
Hôpital Femme Mère Enfant, Lyon; Paediatric Department Not yet recruiting
Lyon, Bron cedex, France, 69677
Principal Investigator: Pierre Cochat, M.D.         
Germany
Universitätsklinikum Bonn, Department of Paediatric Nephrology Not yet recruiting
Bonn, Germany, DE-53113
Principal Investigator: Bernd Hoppe, M.D.         
Sponsors and Collaborators
OxThera
FP7-SME-2013 Research for the benefit of SMEs program
Investigators
Principal Investigator: Dawn Milliner, M.D. Mayo Clinic
  More Information

No publications provided

Responsible Party: OxThera
ClinicalTrials.gov Identifier: NCT02000219     History of Changes
Other Study ID Numbers: OC5-OL-01
Study First Received: November 20, 2013
Last Updated: November 26, 2013
Health Authority: United States: Food and Drug Administration
Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé

Keywords provided by OxThera:
hyperoxaluria
oxalate
PH
dialysis

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

ClinicalTrials.gov processed this record on July 26, 2014