Trial document





This study has been imported from ClinicalTrials.gov without additional data checks.
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  DRKS00006436

Trial Description

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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

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Trial Acronym

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URL of the Trial

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Brief Summary in Lay Language

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.

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Brief Summary in Scientific Language

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Organizational Data

  •   DRKS00006436
  •   2015/01/09
  •   2013/11/20
  •   no
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Secondary IDs

  •   NCT02000219  (ClinicalTrials.gov)
  •   OC5-OL-01  (OxThera)
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Health Condition or Problem studied

  •   Primary Hyperoxaluria
  •   E74.8 -  Other specified disorders of carbohydrate metabolism
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Interventions/Observational Groups

  •   Biological: Oxalobacter formigenes
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Characteristics

  •   Interventional
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  •   Single arm study
  •   Open (masking not used)
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  •   Uncontrolled/Single arm
  •   Treatment
  •   Single (group)
  •   II
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Primary Outcome

- 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)

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Secondary Outcome

- 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.

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Countries of Recruitment

  •   United States
  •   France
  •   Germany
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Locations of Recruitment

  •  
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Recruitment

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  •   2014/02/27
  •   8
  •   Multicenter trial
  •   International
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Inclusion Criteria

  •   Both, male and female
  •   no minimum age
  •   no maximum age
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Additional 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.

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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.

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Addresses

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    • OxThera
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    • FP7-SME-2013 Research for the benefit of SMEs program
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    • Mayo Clinic
    • Dawn Milliner, M.D. 
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    • Anna Sjögren 
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Sources of Monetary or Material Support

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    • Bitte wenden Sie sich an den Sponsor / Please refer to primary sponsor
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    •   [---]*
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Status

  •   Recruiting planned
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Trial Publications, Results and other Documents

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The parameters in ClinicalTrials.gov and DRKS are not identical. Therefore the data import from ClinicalTrials.gov required adjustments. For full details please see the DRKS FAQs .
  •   1
  •   2014/07/16
* This entry means the parameter is not applicable or has not been set.