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Status unknownNCT04377243Updated May 8, 2020

Immunotherapy of Chronic Kidney Failure

A Phase 2 interventional study of V8 in Renal Failure Chronic, sponsored by Immunitor LLC. Status unknown at 1 site in Mongolia. Per ClinicalTrials.gov, last updated 2020-05-08.

Sponsored by Immunitor LLC · Phase 2, Interventional, and Treatment

The sponsor has not verified this record recently (last verified May 2020), so the status shown — last known as Not yet recruiting — may be out of date.
Phase
Phase 2
Study type
Interventional
Enrollment
20
Allocation
Randomized
Sex
All
01

Study 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.

02

Conditions studied

  • Renal Failure Chronic
03

In context

Renal Insufficiency, Chronic

3,090 studies on the registry are indexed under Renal Insufficiency, Chronic; 698 are open to participants now.

This study's planned enrollment of 20 is below the median of 73 across 2,157 interventional studies indexed under Renal Insufficiency, Chronic.

Browse Renal Insufficiency, Chronic studies →

Lead sponsor

Immunitor LLC is the lead sponsor of 14 studies on the registry; none are open to participants now.

Counted across the registry records on this site, refreshed daily.

04

Who can participate

Ages eligible
Child (0–17), Adult (18–64), Older adult (65+)
Sexes eligible
All
Accepts healthy volunteers
No

Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.

Inclusion criteria

  • Baseline level of creatinine twice above normal

Exclusion criteria

Exclusion Criteria:

  • Baseline level of creatinine normal
05

Study design

Phase
Phase 2
Primary purpose
Treatment
Allocation
Randomized
Intervention model
Parallel assignment
Masking
Double (Participant, Care provider)
Enrollment
20 participants (estimated)

Study arms

  • 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

  • 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

Interventions

  • BiologicalV8

    one pill per day either V8 or placebo

    Also known as: Placebo

06

What researchers measure

Primary outcomes

  1. Effect on creatinine

    Change in serum creatinine level from baseline

    Time frame: 1 month

07

Study locations

1 site
  • Immunitor LLC
    Ulaanbaatar, Mongolia
08

Timeline

Tracking since Sep 25, 2026
ElapsedEstimatedEstimated, not yet reachedSimilar studies: half by the dot; the band is the middle halfHalf of similar studies reached it by the dot; the band is the middle half, from a quarter to three quarters

Start is estimated for Jun 2020; primary completion for May 2021, 10 months later.

Of 80 industry-sponsored phase 2 interventional studies under Renal Insufficiency, Chronic, half reached primary completion within 19 months of starting (the median), counting those still running; a quarter within 12 and three quarters within 31. This study's planned 10 months is below that.

Counting every sponsor, half of 139 studies reached it within 25 months; a quarter within 15 and three quarters within 43.

How these figures are worked out, and which studies are left out of them.

Registered
May 2, 2020
First posted
May 6, 2020
StartEst.
Jun 16, 2020
Primary completionEst.
May 15, 2021
CompletionEst.
Sep 1, 2021
Last update
May 8, 2020
What these dates mean
Start.
When the first participant enrolled; while estimated, when the study expects to open to recruitment.
Primary completion.
When the last participant was examined or treated to collect data for the study's main question, its primary outcome. A study that stopped early gives the date its data collection stopped.
Completion.
When the last participant's last visit took place, for every outcome, secondary ones and side effects included: the end of the study. Often later than primary completion, sometimes the same day.
Actual and Est.
Actual means the registry says the date has happened. Est. (estimated) is a date the sponsor plans or expects. It can still move, and the sponsor is expected to change it to actual once it has passed.
No changes since tracking began. The registry record was last updated on May 8, 2020, before this site started recording changes on Sep 25, 2026. Its history is on ClinicalTrials.gov ↗
09

Registry details

Key details

Study ID
NCT04377243
Lead sponsor
Immunitor LLC
Responsible party
Sponsor
First posted
May 6, 2020
Start date
Jun 16, 2020 (estimated)
Primary completion
May 15, 2021 (estimated)
Completion
Sep 1, 2021 (estimated)
Last update
May 8, 2020

Study contacts

Aldar Bourinbaiar, MD/PhD
Contact
aldar@immunitor.com
13014760930
Marina Tarakanovskaya, MD
Contact
info@immunitor.com
+97695130306

Oversight

Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
View the source record on ClinicalTrials.gov ↗

Not currently enrolling

This study is status unknown, as verified in May 2020. You cannot join it, but the record below documents what was studied.

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Discussion

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