Phase II Trial of V8 in Treating Kidney Failure
Overview
- Phase
- Phase 2
- Intervention
- Not specified
- Conditions
- Renal Failure Chronic
- Sponsor
- Immunitor LLC
- Enrollment
- 20
- Locations
- 1
- Primary Endpoint
- Effect on creatinine
- Last Updated
- 5 years ago
Overview
Brief Summary
Kidney failure can result from inflammatory renal disease in the context of autoimmunity because the kidney is targeted by host's immune response against self. There are many causes to this, but abnormal kidney function tests, i.e., BUN and creatinine, can reveal the disease. Oral delivery of kidney cells is ought to produce the immune tolerance - phenomenon is known as oral tolerance. Preliminary studies produced convincing evidence that this hypothesis holds true and has not produced any adverse side effects. Intended open label Phase II aims to confirm these findings.
Investigators
Eligibility Criteria
Inclusion Criteria
- •Baseline level of creatinine twice above normal
Exclusion Criteria
- •Baseline level of creatinine normal
Outcomes
Primary Outcomes
Effect on creatinine
Time Frame: 1 month
Change in serum creatinine level from baseline