Trial record 3 of 13 for:    "primary hyperoxaluria"

Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria

This study is currently recruiting participants. (see Contacts and Locations)
Verified December 2013 by OxThera
Sponsor:
Collaborator:
FP7-SME-2013 Research for the benefit of SMEs program
Information provided by (Responsible Party):
OxThera
ClinicalTrials.gov Identifier:
NCT02012985
First received: December 11, 2013
Last updated: NA
Last verified: December 2013
History: No changes posted
  Purpose

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering urinary oxalate levels in patients with primary hyperoxaluria.


Condition Intervention Phase
Primary Hyperoxaluria
Biological: Oxabact OC5 capsules
Phase 1
Phase 2

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: A Phase 1/2, Randomised, Placebo-controlled, Double-blind, Multi-centre Study to Evaluate the Efficacy and Safety of OC5 to Reduce Urinary Oxalate in Subjects With Primary Hyperoxaluria

Resource links provided by NLM:


Further study details as provided by OxThera:

Primary Outcome Measures:
  • Change in urinary oxalate levels from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]

Secondary Outcome Measures:
  • Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]

    Change in urinary oxalate levels from Baseline to week 8 of treatment in subsets of subjects defined by:

    • baseline urinary oxalate level, above and below 1.5 mmol/24h/1.73m2
    • concomitant vitamin B6 therapy and no vitamin B6 therapy
    • eGFR of ≥90 mL/min/1.73m2 (normal renal function) and < 90 mL/min/1.73m2 (mild to moderate reduction in renal function)
    • age below 18 and age 18 or above

  • Number of subjects who reach urinary oxalate levels below 0.5, 0.7 and 1.0 mmol/24h/1.73m2 respectively from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]
  • Change in plasma oxalate levels from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]
  • Change in urinary oxalate levels from Baseline to week 4 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 10 of the study) ] [ Designated as safety issue: No ]
  • Correlation between change in plasma oxalate levels and change in urinary oxalate levels, from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]
  • Change in number of O. formigenes in faeces from Baseline to week 8 of treatment. [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: No ]
  • Adverse events [ Time Frame: 8 weeks of active treatment (i.e. between Weeks 7 and 14 of the study) ] [ Designated as safety issue: Yes ]
  • Haematology [ Time Frame: 14 weeks (Throughout the study) ] [ Designated as safety issue: Yes ]
    Blood samples taken for hematology at weeks 0, 5, 10 and 14. Complete blood count with differential and platelet count evaluated.

  • Clinical Chemistry [ Time Frame: 14 weeks (Throughout the study) ] [ Designated as safety issue: Yes ]
    Blood samples taken for clinical chemistry at weeks 0, 5, 10 and 14. Blood Urea Nitrogen, creatinine, electrolytes (Na+, K+, Mg++, Ca++, HCO3+, Cl), glucose, pH, albumin, alkaline phosphatase, ALT, AST, total bilirubin and total protein evaluated.

  • Urinalysis [ Time Frame: 14 weeks (Throughout the study) ] [ Designated as safety issue: Yes ]
    Urine samples will be taken at weeks 0, 5, 10 and 14 of the study. Protein, glucose and pH evaluated.


Estimated Enrollment: 24
Study Start Date: December 2013
Estimated Study Completion Date: July 2014
Estimated Primary Completion Date: July 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Oxabact OC5 capsules
The active study drug consists of OC5 in enteric-coated size-4 capsules. The dose will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.
Biological: Oxabact OC5 capsules
The dose will be not less than (NLT) 1E+09 colony forming units (CFU) twice daily for 8 to 10 weeks. The dose (an enteric-coated size 4 capsule) will be administered orally with breakfast and dinner.
Other Name: Oxalobacter formigenes
Placebo Comparator: Placebo capsules
The placebo study drug consists of microcrystalline cellulose in enteric-coated size-4 capsules. The dose will be administrated orally with breakfast and dinner as one capsule two times per day for 8 to 10 weeks.

  Eligibility

Ages Eligible for Study:   2 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Signed informed consent (as applicable for the age of the subject).
  • Male or female subjects ≥ 2 years of age (Germany & France) / Male or female subjects ≥ 5 years of age (United Kingdom)
  • A diagnosis of PH type I (as determined by standard diagnostic methods).
  • A mean urinary oxalate excretion of > 1.0 mmol/24h/1.73m2, based on at least three eligible urine collections performed during baseline (weeks 1-4).
  • Renal function defined as an estimated GFR ≥ 40 ml/min normalised to 1.73m2 body surface area, or a creatinine clearance of ≥ 40 ml/min normalised to 1.73m2 body surface area.
  • Subjects 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. Subjects not receiving vitamin B6 at study entry must be willing to refrain from initiating pyridoxine during study participation.

Exclusion Criteria:

  • Inability to collect complete 24-hour urine samples. Each urine collection will be evaluated for completeness based on urine qualitative criteria.
  • Inability to swallow size 4 capsules twice daily for 8 to 10 weeks.
  • Subjects that have undergone transplantation (solid organ or bone marrow).
  • 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, including chronic use, a history of more than two courses of antibiotic use during the past 6 months, current antibiotic use, or antibiotics use within 14 days of initiating study medication.
  • Subjects who require immune suppressive therapy.
  • Current treatment with ascorbic acid preparation.
  • Pregnancy.
  • Women of child-bearing potential who are not using adequate contraceptive precautions such as oral, transdermal, injectable, or implanted contraceptives, IUD, complete abstinence, use of a condom by the sexual partner, or sterile sexual partner.
  • 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.
  • Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to screening 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: NCT02012985

Contacts
Contact: Anna Sjögren +46 8 660 0223 anna.sjogren@oxthera.com
Contact: Orla N Mc Callion, BSc PhD +46 8 660 0223 orla.mccallion@oxthera.com

Locations
France
Hôpital des Enfants, Centre de référence maladies rénales rares du Sud-Ouest (SORARE), CHU de Bordeaux Not yet recruiting
Bordeaux, France, 33076
Principal Investigator: Jérôme Harambat, MD         
Hôpital Femme Mère Enfant, Lyon - Paediatric Dept Not yet recruiting
Lyon, France, 69677 Bron
Principal Investigator: Pierre Cochat, MD         
Hôpital Necker-Enfants Malades,Centre de référence des Maladies Rénales Héréditaires de l'Enfant et de l'Adulte (MARHEA) Not yet recruiting
Paris, France, 75015
Principal Investigator: Rémi Salomon, MD         
Germany
Universitätsklinikum Bonn, Dept of Paediatric Nephrology Recruiting
Bonn, Germany, DE-53113
Principal Investigator: Bernd Hoppe, MD PhD         
United Kingdom
Birmingham Children's Hospital NHS Foundation Trust - Dept of Nephrology Not yet recruiting
Birmingham, United Kingdom, B4 6NH
Principal Investigator: Sally Hulton, MD         
Royal Free Hospital -UCL Centre for Nephrology Not yet recruiting
London, United Kingdom, NW3 2QG
Principal Investigator: Shabbir Moochhala, MCRP PhD         
Great Ormond Street Hospital for Children NHS Trust Not yet recruiting
London, United Kingdom, WCIN 3JH
Principal Investigator: William van't Hoff, FRCP         
Sponsors and Collaborators
OxThera
FP7-SME-2013 Research for the benefit of SMEs program
Investigators
Principal Investigator: Bernd Hoppe, MD PhD Universitätsklinikum Bonn, Dept of Paediatric Nephrology
  More Information

No publications provided

Responsible Party: OxThera
ClinicalTrials.gov Identifier: NCT02012985     History of Changes
Other Study ID Numbers: OC5-DB-01
Study First Received: December 11, 2013
Last Updated: December 11, 2013
Health Authority: Germany: Federal Institute for Drugs and Medical Devices
France: Agence Nationale de Sécurité du Médicament et des produits de santé
United Kingdom: Medicines and Healthcare Products Regulatory Agency

Keywords provided by OxThera:
hyperoxaluria
oxalate
PH

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 August 19, 2014