Study to Evaluate the Efficacy and Safety of Oxabact (OC5) in Primary Hyperoxaluria Patients Who Are on Dialysis

Primary Hyperoxaluria Clinical Trial

Official title:

A Phase 2 Open-label Multi-centre Study to Evaluate the Efficacy and Safety of Oxabact® to Reduce Plasma Oxalate in Subjects With Primary Hyperoxaluria Who Are on Dialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02000219
• Other study ID #: OC5-OL-01
• Status: Completed
• Phase: Phase 2
• Start date: May 19, 2014
• Est. completion date: January 29, 2020

Study information

• Verified date: October 2021
• Source: OxThera
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

The purpose of this study is to determine if Oxalobacter formigenes is effective at lowering plasma oxalate levels in patients with primary hyperoxaluria who are on dialysis.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 12
• Est. completion date: January 29, 2020
• Est. primary completion date: January 29, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 2 Years and older

Eligibility

Inclusion Criteria:

1. Signed informed consent (as applicable for the age of the subject). An appendix to the informed consent will be signed by patients continuing on treatment after week 14.

2. Male or female subjects = 2 years of age. Subjects have to be able to swallow size 4 capsules twice daily for 6 weeks, or use a gastric tube that allows for administration of size 4 capsules.

3. A diagnosis of PH (as determined by standard diagnostic methods).

4. Patient should be on a stable dialysis regimen for at least two weeks before baseline.

5. Pre-dialysis plasma oxalate =40 micromole/L.

6. Patients receiving vitamin B6 must be receiving a stable dose for at least 3 months prior to screening and must remain on the stable dose during the study. Patients not receiving vitamin B6 at study entry must be willing to refrain from initiating vitamin B6 during study participation.

Exclusion Criteria:

7. Inability to swallow size 4 capsules twice daily for 6 weeks or using a gastric tube not suited for administration of size 4 capsules via the tube.

8. Ongoing treatment with immunosuppressive medication.

9. 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.

10. Use of antibiotics to which O. formigenes is sensitive, including current antibiotic use, or antibiotics use within 14 days of initiating study medication.

11. Current treatment with a separate ascorbic acid preparation. Standard of care vitamin supplement for patients on dialysis is allowed.

12. Pregnancy.

13. Women of childbearing 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 OC5 and must agree to continue using such precautions during the clinical study.

14. 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.

15. Participation in any study of an investigational product, biologic, device, or other agent within 30 days prior to the first dose of OC5 or not willing to forego other forms of investigational treatment during this study.

Related Conditions & MeSH terms

• Hyperoxaluria, Primary
• Primary Hyperoxaluria

Intervention

Biological:
• Oxalobacter formigenes
The dose will be (not less than) NLT =1E+09 colony forming units (CFU) twice daily. The dose (an enteric-coated capsule) will be administered orally with breakfast and dinner.

Locations

Country	Name	City	State
Germany	Universitätsklinikum Bonn, Department of Paediatric Nephrology	Bonn

Sponsors (2)

Lead Sponsor	Collaborator
OxThera	FP7-SME-2013 Research for the benefit of SMEs program

Country where clinical trial is conducted

Germany, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Change in Pre Dialysis Plasma Oxalate (Total Plasma Oxalate) Level During Treatment With OC5 Compared With Baseline.	Total plasma oxalate measured in umol/L	Baseline (average of week 2 & 4 pretreatment); treatment weeks 6, 8 & 10 (on treatment 2, 4, & 6 weeks); off treatment weeks 12 & 14 (2 & 4 weeks off treatment); patients were then eligible for treatment up to 3 years & oxalate was measured every 6 months
Secondary	Change in Pre Dialysis Plasma Oxalate (Free Plasma Oxalate) Level During Study Compared With Baseline.	Comparison of free plasma oxalate compared to the four week baseline period.	Baseline (average of week 2 & 4 pretreatment); treatment weeks 6, 8 & 10 (on treatment 2, 4, & 6 weeks); off treatment weeks 12 & 14 (2 & 4 weeks off treatment); patients were then eligible for treatment up to 3 years & oxalate was measured every 6 months
Secondary	Change in Left Ventricular Ejection Fraction From Baseline.	Mean left ventricular ejection fraction measured as a percentage. Reference range 55-70%.	At baseline and approximately every 6 months throughout the 3 year continued treatment.
Secondary	Speckle Tracking Echocardiography	Global longitudinal strain (GLS), which measures the maximal shortening of myocardial longitudinal length during systole compared to the resting length in diastole. The normal range for GLS is considered to be < -18%.	At baseline and approximately every 6 months throughout the 3 year continued treatment.