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Clinical Trials/NCT04377243
NCT04377243
Unknown
Phase 2

Phase II Trial of V8 in Treating Kidney Failure

Immunitor LLC1 site in 1 country20 target enrollmentJune 16, 2020

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.

Registry
clinicaltrials.gov
Start Date
June 16, 2020
End Date
September 1, 2021
Last Updated
5 years ago
Study Type
Interventional
Study Design
Parallel
Sex
All

Investigators

Sponsor
Immunitor LLC
Responsible Party
Sponsor

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

Study Sites (1)

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