Renal Failure Chronic
Conditions
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.
Interventions
BIOLOGICALV8
one pill per day either V8 or placebo
Sponsors
Immunitor LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Caregiver)
Masking description
neither patients nor attending physician are aware
Eligibility
Sex/Gender
ALL
Healthy volunteers
No
Inclusion criteria
* Baseline level of creatinine twice above normal
Exclusion criteria
* Baseline level of creatinine normal
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Effect on creatinine | 1 month | Change in serum creatinine level from baseline |
Countries
Mongolia
Contacts
Primary ContactAldar Bourinbaiar, MD/PhD
Backup ContactMarina Tarakanovskaya, MD
Outcome results
None listed