NCT04377243

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
20

participants targeted

Target at below P25 for phase_2

Timeline
Completed

Started Jun 2020

Shorter than P25 for phase_2

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

May 2, 2020

Completed
4 days until next milestone

First Posted

Study publicly available on registry

May 6, 2020

Completed
1 month until next milestone

Study Start

First participant enrolled

June 16, 2020

Completed
11 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

May 15, 2021

Completed
4 months until next milestone

Study Completion

Last participant's last visit for all outcomes

September 1, 2021

Completed
Last Updated

May 8, 2020

Status Verified

May 1, 2020

Enrollment Period

11 months

First QC Date

May 2, 2020

Last Update Submit

May 6, 2020

Conditions

Renal Failure Chronic

Outcome Measures

Primary Outcomes (1)

  • Effect on creatinine

    Change in serum creatinine level from baseline

    1 month

Study Arms (2)

V8 850 mg

EXPERIMENTAL

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

Biological: V8

Placebo 850 mg

PLACEBO COMPARATOR

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

Biological: V8

Interventions

V8BIOLOGICAL

one pill per day either V8 or placebo

Also known as: Placebo
Placebo 850 mgV8 850 mg

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Baseline level of creatinine twice above normal

You may not qualify if:

  • Baseline level of creatinine normal

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Immunitor LLC

Ulaanbaatar, Mongolia

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Central Study Contacts

Aldar Bourinbaiar, MD/PhD

CONTACT

13014760930aldar@immunitor.com

Marina Tarakanovskaya, MD

CONTACT

+97695130306info@immunitor.com

Study Design

Study Type
interventional
Phase
phase 2
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, CARE PROVIDER
Masking Details
neither patients nor attending physician are aware
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

May 2, 2020

First Posted

May 6, 2020

Study Start

June 16, 2020

Primary Completion

May 15, 2021

Study Completion

September 1, 2021

Last Updated

May 8, 2020

Record last verified: 2020-05

Locations

MO(1)