Immunotherapy of Chronic Kidney Failure

Phase 2

• Conditions: Renal Failure Chronic
• Interventions: Biological: V8

• Registration Number: NCT04377243
• Lead Sponsor: Immunitor LLC

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.

Detailed Description

Not available

Study Timeline

• Status Verified: 2020-05
• Study First Submitted: 2020-05-02
• Study First Submitted QC: 2020-05-02
• Study First Posted: 2020-05-06
• Last Update Submitted: 2020-05-06
• Last Update Posted: 2020-05-08
• Study Start: 2020-06-16
• Primary Completion: 2021-05-15
• Study Completion: 2021-09-01

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 20

Inclusion Criteria

• Baseline level of creatinine twice above normal

Exclusion Criteria

• Baseline level of creatinine normal

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
Placebo 850 mg	V8	Arm: 2 Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of placebo
V8 850 mg	V8	Arm 1: Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of V8

Primary Outcome Measures

Name	Time	Method
Effect on creatinine	1 month	Change in serum creatinine level from baseline

Trial Locations

Locations (1)

Immunitor LLC; 🇲🇳 Ulaanbaatar, Mongolia