Immunotherapy of Chronic Kidney Failure

May 6, 2020 updated by: Immunitor LLC

Phase II Trial of V8 in Treating Kidney Failure

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

20

Phase

  • Phase 2

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Mongolia
      • Ulaanbaatar, Mongolia
        • Immunitor LLC

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

  • ADULT
  • OLDER_ADULT
  • CHILD

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • Baseline level of creatinine twice above normal

Exclusion Criteria:

  • Baseline level of creatinine normal

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: DOUBLE

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
EXPERIMENTAL: 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
Biological: V8
one pill per day either V8 or placebo
Other Names:
  • Placebo
PLACEBO_COMPARATOR: 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
Biological: V8
one pill per day either V8 or placebo
Other Names:
  • Placebo

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Effect on creatinine
Time Frame: 1 month
Change in serum creatinine level from baseline
1 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Immunitor LLC

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ANTICIPATED)

June 16, 2020

Primary Completion (ANTICIPATED)

May 15, 2021

Study Completion (ANTICIPATED)

September 1, 2021

Study Registration Dates

First Submitted

May 2, 2020

First Submitted That Met QC Criteria

May 2, 2020

First Posted (ACTUAL)

May 6, 2020

Study Record Updates

Last Update Posted (ACTUAL)

May 8, 2020

Last Update Submitted That Met QC Criteria

May 6, 2020

Last Verified

May 1, 2020

More Information

Terms related to this study

Additional Relevant MeSH Terms

Other Study ID Numbers

  • V8

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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