Immunotherapy of Chronic Kidney Failure

NCT ID: NCT04377243

Last Updated: 2020-05-08

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE2

Total Enrollment

20 participants

Study Classification

INTERVENTIONAL

Study Start Date

2020-06-16

Study Completion Date

2021-09-01

Brief Summary

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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

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Conditions

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Renal Failure Chronic

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Caregivers
neither patients nor attending physician are aware

Study Groups

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V8 850 mg

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

Group Type EXPERIMENTAL

V8

Intervention Type BIOLOGICAL

one pill per day either V8 or placebo

Placebo 850 mg

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

Group Type PLACEBO_COMPARATOR

V8

Intervention Type BIOLOGICAL

one pill per day either V8 or placebo

Interventions

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V8

one pill per day either V8 or placebo

Intervention Type BIOLOGICAL

Other Intervention Names

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Placebo

Eligibility Criteria

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Inclusion Criteria

* Baseline level of creatinine twice above normal

Exclusion Criteria

* Baseline level of creatinine normal
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Immunitor LLC

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Locations

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Immunitor LLC

Ulaanbaatar, , Mongolia

Site Status

Countries

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Mongolia

Central Contacts

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Aldar Bourinbaiar, MD/PhD

Role: CONTACT

13014760930

Marina Tarakanovskaya, MD

Role: CONTACT

+97695130306

Other Identifiers

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V8

Identifier Type: -

Identifier Source: org_study_id

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