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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT00638703
Other study ID # OC3-DB-01
Secondary ID DB-01
Status Completed
Phase Phase 2/Phase 3
First received March 12, 2008
Last updated May 7, 2013
Start date October 2007
Est. completion date October 2008

Study information

Verified date June 2011
Source OxThera
Contact n/a
Is FDA regulated No
Health authority European Union: European Medicines AgencyFrance: Afssaps - Agence française de sécurité sanitaire des produits de santé (Saint-Denis)Germany: Federal Institute for Drugs and Medical DevicesNetherlands: The Central Committee on Research Involving Human Subjects (CCMO)United Kingdom: Medicines and Healthcare Products Regulatory AgencyUnited States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

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


Recruitment information / eligibility

Status Completed
Enrollment 43
Est. completion date October 2008
Est. primary completion date September 2008
Accepts healthy volunteers No
Gender Both
Age group 5 Years and older
Eligibility Inclusion Criteria:

1. The subject (or legally acceptable representative) must give written informed consent (and assent for subjects = 12 years or country specific age as appropriate). For subjects less than 18 years of age, parent or guardian will provide informed consent and the subject will provide witnessed verbal assent

2. Male or female subjects = 5 years of age

3. Urinary oxalate excretion of > 1.0 mmol/1.73m2/day at Baseline

4. Documentation of diagnosis of PH I or PH II by any one of the following:

1. Liver biopsy confirmation of deficient liver specific peroxisomal alanine-glyoxylate aminotransferase, (AGT) or mislocalization of AGT from peroxisomes to mitochondria (PH I) or deficient glyoxylate reductase/hydroxypyruvate reductase (GR/HPR) activity (PH II)

2. Homozygosity or compound heterozygosity for a known mutation in the causative genes for PH I and PH II

3. Increased glycolate excretion for PH I or increased L-glycerate excretion for PH II

5. Subjects receiving pyridoxine must be receiving a stable dose for at least 3 months prior to entry in to the study and must remain on the stable dose during the study. Other (non-pyridoxine naïve) subjects (e.g. Pyridoxine non-responder: <30% reduction of the urine oxalate levels) not receiving pyridoxine at study entry must be willing to refrain from initiating pyridoxine during study participation. Note: There will be no pyridoxine-naïve subjects enrolled in the study.

6. Renal function defined as an estimated GFR = 50 ml/min normalized to 1.73m2 body surface area

Exclusion Criteria:

1. Pregnant, lactating, or actively menstruating women and women of child-bearing 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 OxabactTM and must agree to continue using such precautions during the clinical study.

Note: A highly effective method of birth control is defined as one that results in a low failure rate (i.e. less than 1% per year) when used consistently and correctly, such as implants, injectables, combined oral contraceptives, some intrauterine contraceptive devices (IUDs), sexual abstinence, or a vasectomised partner.

2. Positive serum pregnancy test.

3. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to randomization or not willing to forego other forms of investigational treatment during this study.

4. Subjects on hemodialysis or peritoneal dialysis.

5. Subjects who have undergone transplantation (solid organ or bone marrow).

6. Chronic gastrointestinal disease associated with enteric hyperoxaluria, e.g. history of inflammatory bowel disease, colostomy. Note: For clarity, existence of Secondary Hyperoxaluria (e.g. with cystic fibrosis, chronic inflammatory bowel diseases, short bowel syndrome and/or deficiency of intestinal oxalate-degrading bacteria is included (as an exclusion criteria).

7. Current systemic (oral, IM, IV) antibiotic use or received systemic antibiotics within 14 days of study enrolment.

8. History of chronic, recurrent infections requiring >2 courses of antibiotics in the past 6 months.

9. History of malignancy except for basal or squamous cell skin cancer that has been excised.

10. Unable to collect 24-hour urine samples or follow other study procedures.

11. Subjects who cannot swallow a size 2 capsule.

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. Subjects who require immune suppressive therapy (including prednisone of > 10mg daily for more than 2 weeks).

14. Subjects from correctional facilities or asylums.

15. Subjects who are mentally handicapped.

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), Primary Purpose: Treatment


Related Conditions & MeSH terms


Intervention

Biological:
Oxalobacter formigenes
NLT (not less than) 10^7 CFU Oxalobacter formigenes twice daily for 24 weeks
Drug:
Placebo
placebo

Locations

Country Name City State
United States Mayo Clinic (Department of Pediatric Nephrology) Rochester Minnesota

Sponsors (1)

Lead Sponsor Collaborator
OxThera

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Reduction in urinary oxalate Percentage change in urinary oxalate (expressed as mmole/1.73m2 /day) from Baseline to Week 24 24 weeks No
Secondary Percentage of subjects who are responders at Week 24 where response is defined as a 20% or greater reduction from Baseline urinary oxalate to Week 24 24 weeks No
Secondary Percentage change in urinary oxalate (expressed as molar oxalate to creatinine ratio) from Baseline to Week 24 24 weeks No
Secondary Percentage change in urinary oxalate (expressed as mmole/1.73m2/day and as molar oxalate to creatinine ratio) from Baseline to Week 12 12 weeks No
Secondary Percentage change in urinary oxalate (expressed as mmole/1.73m2/day and as molar oxalate to creatinine ratio) from Baseline to average of Weeks 12 and 24 12 and 24 weeks No
Secondary Frequency of AEs and SAEs over 24 weeks Yes
Secondary Laborator safety data 12 and 24 weeks Yes
See also
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Recruiting NCT02026388 - Rare Kidney Stone Consortium Biobank
Completed NCT02000219 - Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis Phase 2
Recruiting NCT05843851 - Genetic Newborn Screening for Cystinosis and Primary Hyperoxaluria N/A
Recruiting NCT00588562 - Rare Kidney Stone Consortium Patient Registry
Completed NCT03391804 - Study of ALLN-177 in Patients Aged 12 Years or Older With Enteric or Primary Hyperoxaluria and Hyperoxalemia Phase 2
Completed NCT03116685 - A Study to Evaluate the Efficacy and Safety of Oxabact in Patients With Primary Hyperoxaluria Phase 3
Recruiting NCT05107830 - Phenotyping of Primary Hyperoxaluria
Active, not recruiting NCT04152200 - A Study to Evaluate Lumasiran in Patients With Advanced Primary Hyperoxaluria Type 1 Phase 3
Recruiting NCT05001269 - Nedosiran in Pediatric Patients From Birth to 11 Years of Age With PH and Relatively Intact Renal Function Phase 2
Completed NCT03392896 - Study of DCR-PHXC-101 in Normal Healthy Volunteers and Patients With Primary Hyperoxaluria Phase 1
Completed NCT02012985 - Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Patients With Primary Hyperoxaluria Phase 1/Phase 2
Completed NCT01037231 - Phase 2/3 Oxabact Study Phase 2/Phase 3
Completed NCT00589225 - Primary Hyperoxaluria Mutation Genotyping Phase 1
Completed NCT02124395 - Health-related Quality of Life in Rare Kidney Stone
Completed NCT03350451 - An Extension Study of an Investigational Drug, Lumasiran (ALN-GO1), in Participants With Primary Hyperoxaluria Type 1 Phase 2