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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
Last Update Posted : May 11, 2021
Sponsor:
Information provided by (Responsible Party):
OxThera

Tracking Information
First Submitted Date  ICMJE April 7, 2017
First Posted Date  ICMJE April 17, 2017
Last Update Posted Date May 11, 2021
Actual Study Start Date  ICMJE January 9, 2018
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: February 9, 2018)
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
Original Primary Outcome Measures  ICMJE
 (submitted: April 14, 2017)
Change from baseline in plasma oxalate concentration after 52 weeks of treatment [ Time Frame: 52 weeks ]
Change from baseline in plasma oxalate concentration after 52 weeks of treatment
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Official Title  ICMJE A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Brief Summary This study will evaluate the efficacy and safety of OC5 in patients with PH.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 3
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Condition  ICMJE Primary Hyperoxaluria
Intervention  ICMJE
  • Biological: Oxabact OC5 - Oxalobacter formigenes HC-1
    Active study drug
  • Other: Placebo
    Placebo
Study Arms  ICMJE
  • Experimental: Oxabact OC5 capsules
    Oxabact OC5 - Oxalobacter formigenes HC-1
    Intervention: Biological: Oxabact OC5 - Oxalobacter formigenes HC-1
  • Placebo Comparator: Placebo capsules
    Placebo
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Completed
Actual Enrollment  ICMJE
 (submitted: June 18, 2020)
25
Original Estimated Enrollment  ICMJE
 (submitted: April 14, 2017)
18
Actual Study Completion Date  ICMJE April 15, 2021
Actual Primary Completion Date April 15, 2021   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 2 Years and older   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE Belgium,   France,   Germany,   Spain,   Tunisia,   United Kingdom,   United States
Removed Location Countries Netherlands
 
Administrative Information
NCT Number  ICMJE NCT03116685
Other Study ID Numbers  ICMJE OC5-DB-02
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party OxThera
Study Sponsor  ICMJE OxThera
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account OxThera
Verification Date May 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP