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NCT04377243 Clinical Trial

Immunotherapy of Chronic Kidney Failure

Renal Failure Chronic Clinical Trial

Official title:
Phase II Trial of V8 in Treating Kidney Failure

Clinical Trial Details — Status: Not yet recruiting

Administrative data
NCT number NCT04377243
Other study ID # V8
Secondary ID
Status Not yet recruiting
Phase Phase 2
First received
Last updated
Start date June 16, 2020
Est. completion date September 1, 2021

Study information
Verified date May 2020
Source Immunitor LLC
Contact Aldar Bourinbaiar, MD/PhD
Phone 13014760930
Email aldar@immunitor.com
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial 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.

Recruitment information / eligibility
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

Study Design

Related Conditions & MeSH terms

Intervention

Biological:
• V8
one pill per day either V8 or placebo

Locations
Country Name City State
Mongolia Immunitor LLC Ulaanbaatar

Sponsors (1)
Lead Sponsor Collaborator
Immunitor LLC

Country where clinical trial is conducted

Mongolia, 

Outcome
Type Measure Description Time frame Safety issue
Primary Effect on creatinine Change in serum creatinine level from baseline 1 month
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