ClinicalTrials.gov
ClinicalTrials.gov Menu
Trial record 1 of 1 for:    OC5-DB02
Previous Study | Return to List | Next Study

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. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT03116685
Recruitment Status : Recruiting
First Posted : April 17, 2017
Last Update Posted : October 16, 2018
Sponsor:
Information provided by (Responsible Party):
OxThera

Brief Summary:
This study will evaluate the efficacy and safety of OC5 in patients with PH.

Condition or disease Intervention/treatment Phase
Primary Hyperoxaluria Biological: Oxabact OC5 - Oxalobacter formigenes HC-1 Other: Placebo Phase 3

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 18 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase III Double-blind, Randomised Study to Evaluate the Long-term Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria
Actual Study Start Date : January 9, 2018
Estimated Primary Completion Date : December 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Oxabact OC5 capsules
Oxabact OC5 - Oxalobacter formigenes HC-1
Biological: Oxabact OC5 - Oxalobacter formigenes HC-1
Active study drug

Placebo Comparator: Placebo capsules
Placebo
Other: Placebo
Placebo




Primary Outcome Measures :
  1. 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



Information from the National Library of Medicine

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, Learn About Clinical Studies.


Ages Eligible for Study:   2 Years and older   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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, including 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.

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): NCT03116685


Contacts
Contact: Bastian Dehmel, MD 004686600223 bastian.dehmel@oxthera.com

Locations
United States, Massachusetts
Boston Children's Hospital Recruiting
Boston, Massachusetts, United States, 02115
Contact: Lillian Mead    857-218-3747    Lillian.mead@childrens.harvard.edu   
Principal Investigator: Michelle Baum, MD         
United States, Minnesota
Mayo Clinic Recruiting
Rochester, Minnesota, United States, 55905
Contact: Jenn Manggaard, CCRP    507-255-7768    manggaard.jennifer@mayo.edu   
Principal Investigator: John Lieske, MD         
United States, Tennessee
Vanderbilt University Hospital Recruiting
Nashville, Tennessee, United States, 37232
Contact: Edward R Gould, MD    615-936-1179    edward.r.gould@vumc.org   
Principal Investigator: Edward R Gould, MD         
Belgium
Centre Hospitalier Universitaire de Liège Recruiting
Liège, Belgium
Contact: Laure Collard, MD       Laure.collard@chu.ulg.ac.be   
Principal Investigator: Laure Collard, MD         
France
Hôpital Femme Mère Enfant, CHU de Lyon Recruiting
Lyon, France
Hôpital Robert Debré Recruiting
Paris, France, 75019
Contact: Georges Deschênes, MD       georges.deschenes@aphp.fr   
Principal Investigator: Georges Deschênes, MD         
Germany
Universitätsklinikum Bonn, Dept of Pediatric Nephrology Recruiting
Bonn, Germany, 53113
Contact: Bernd Hoppe, MD    +49 228 935530    bernd.hoppe@ukbonn.de   
Principal Investigator: Bernd Hoppe, MD PhD         
Netherlands
Academy Medical Center, University of Amsterdam Recruiting
Amsterdam, Netherlands
Spain
Hospital Vall d' Hebron Recruiting
Barcelona, Spain
Contact: Gema Ariceta, MD    +34 934893082    gariceta@vhebron.net   
Principal Investigator: Gema Ariceta, MD         
United Kingdom
Royal Free Hospital Recruiting
London, United Kingdom, NW3 2QG
Contact: Rayma Barros-Howe    +44 2074726687 ext 33262      
Sponsors and Collaborators
OxThera

Responsible Party: OxThera
ClinicalTrials.gov Identifier: NCT03116685     History of Changes
Other Study ID Numbers: OC5-DB-02
First Posted: April 17, 2017    Key Record Dates
Last Update Posted: October 16, 2018
Last Verified: October 2018

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No

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