A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria

NCT03116685 | Completed Phase 3 Results DMC FDA Drug

• 1 other identifier: OC5-DB-02
• Study Type: interventional
• Target: 25
• Locations: 7 countries
• Sites: 10

Brief Summary

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

Conditions

Primary Hyperoxaluria

Outcome Measures

Primary Outcomes (1)

• Change From Baseline in Plasma Oxalate Concentration After 52 Weeks of Treatment

  Change from baseline in total plasma oxalate concentration after 52 weeks of treatment in micromole/liter

  52 weeks

Secondary Outcomes (2)

• Change From Baseline in Kidney Function

  52 weeks

• Frequency of Kidney Stone Events

  Through week 48

Study Arms (2)

Oxabact OC5 capsules

EXPERIMENTAL

Oxabact OC5 - Oxalobacter formigenes HC-1

Biological: Oxabact OC5 - Oxalobacter formigenes HC-1

Placebo capsules

PLACEBO COMPARATOR

Placebo

Other: Placebo

Interventions

Oxabact OC5 - Oxalobacter formigenes HC-1 BIOLOGICAL

Active study drug

Oxabact OC5 capsules

Placebo OTHER

Placebo

Placebo capsules

Eligibility Criteria

• Age: 2 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• Signed informed consent (as applicable for the age of the subject)
• A diagnosis of PH (as determined by standard diagnostic methods).
• 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).
• Plasma oxalate concentration ≥10 μmol/L in total plasma oxalate.
• Male or female patients ≥ 2 years of age.
• 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.

You may not qualify if:

• Inability to swallow size 4 capsules.
• Subjects that have undergone transplantation (solid organ or bone marrow).
• Patients requiring dialysis or at immediate risk for kidney failure or expected to be in need of dialysis during the study period.
• 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.
• Use of antibiotics to which O. formigenes is sensitive. (This includes current antibiotic use, or antibiotics use within 14 days of initiating study medication).
• Current treatment with a separate ascorbic acid preparation.
• Pregnant women (or women who are planning to become pregnant) or lactating women.
• Women of childbearing potential who are not using adequate contraceptive precautions. Please see section 7.3 regarding requirements for contraception.
• 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).
• 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.

Sponsors & Collaborators

• OxThera: lead

Study Sites (10)

Vanderbilt University Hospital

Nashville, Tennessee, 37232, United States

Location

Centre Hospitalier Universitaire de Liège

Liège, Belgium

Location

Hôpital Robert Debré

Paris, 75019, France

Location

Kindernierenzentrum Bonn

Bonn, 53127, Germany

Location

Hospital Vall d' Hebron

Barcelona, Spain

Location

Hédi Chaker University Hospital

Sfax, 3000, Tunisia

Location

Sahloul University Hospital

Sousse, 4054, Tunisia

Location

Charles Nicolle University Hospital

Tunis, 1008, Tunisia

Location

Royal Free Hospital

London, NW3 2QG, United Kingdom

Location

Nottingham Children's Hospital

Nottingham, NG7 2UH, United Kingdom

Location

MeSH Terms

Conditions

Hyperoxaluria, Primary

Condition Hierarchy (Ancestors)

Hyperoxaluria; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Carbohydrate Metabolism, Inborn Errors; Metabolism, Inborn Errors; Genetic Diseases, Inborn; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Metabolic Diseases; Nutritional and Metabolic Diseases

Results Point of Contact

• Title: Chief Operating Officer
• Organization: OxThera

elisabeth.lindner@oxthera.com

0046 86600223

Study Officials

• Gesa Schalk, MD

  KindernierenZentrum, Bonn, Germany

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 3
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 7, 2017
• First Posted: April 17, 2017
• Study Start: January 9, 2018
• Primary Completion: April 15, 2021
• Study Completion: April 15, 2021
• Last Updated: December 10, 2021
• Results First Posted: December 9, 2021

Record last verified: 2021-10

Data Sharing

• IPD Sharing: Will not share

Locations

US (1); FR (1); DE (1); BE (1); ES (1); TU (3); GB (2)