Immunotherapy of Chronic Kidney Failure

Immunitor

Status and phase: Unknown; Phase 2

Conditions: Renal Failure Chronic

Treatments: Biological: V8

Study type: Interventional

Funder types: Industry

Identifiers

NCT04377243

V8

Details and patient eligibility

About

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.

Enrollment: 20 estimated patients

Sex: All

Volunteers: No Healthy Volunteers

Inclusion criteria

• Baseline level of creatinine twice above normal

Exclusion criteria

• Baseline level of creatinine normal

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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20 participants in 2 patient groups, including a placebo group

V8 850 mg

Experimental group

Description:

Arm 1: Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of V8

Treatment:

Biological: V8

Placebo 850 mg

Placebo Comparator group

Description:

Arm: 2 Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of placebo

Treatment:

Biological: V8