Renal Failure Chronic Clinical Trial
Official title:
Phase II Trial of V8 in Treating Kidney Failure
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.
| Status | Not yet recruiting |
| Enrollment | 20 |
| Est. completion date | September 1, 2021 |
| Est. primary completion date | May 15, 2021 |
| Accepts healthy volunteers | No |
| Gender | All |
| Age group | N/A and older |
| Eligibility |
Inclusion Criteria: - Baseline level of creatinine twice above normal Exclusion Criteria: - Baseline level of creatinine normal |
| Country | Name | City | State |
|---|---|---|---|
| Mongolia | Immunitor LLC | Ulaanbaatar |
| Lead Sponsor | Collaborator |
|---|---|
| Immunitor LLC |
Mongolia,
| Type | Measure | Description | Time frame | Safety issue |
|---|---|---|---|---|
| Primary | Effect on creatinine | Change in serum creatinine level from baseline | 1 month |
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