Immunotherapy of Chronic Kidney Failure | NCT04377243

Studies
Immunotherapy of Chronic Kidney Failure

NCT04377243

Sponsor

Immunitor LLC

Status

Unknown status

Last Update Posted

May 8, 2020Actual

Enrollment

20Estimated

Phase

Phase 2

Conditions

Renal Failure Chronic

Interventions

Countries

Mongolia

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

May 2020

Overall Recruitment Status or Expanded Access Status

Unknown status

Last Known Status

Not yet recruiting

Delayed Posting

Not provided

Why Stopped

Not provided

Expanded Access Info

Start Date

Jun 16, 2020Estimated

Primary Completion Date

May 15, 2021Estimated

Completion Date

Sep 1, 2021Estimated

First Submitted Date

May 2, 2020

First Submission Date that Met QC Criteria

May 2, 2020

First Posted Date

May 6, 2020Actual

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

May 6, 2020

Last Update Posted Date

May 8, 2020Actual

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Is FDA Regulated Device

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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 provided

Design Module

Study Type

Interventional

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Not provided

Target Follow-Up Duration

Not provided

Phases

Phase 2

Interventional Study Design

Allocation

Biospecimen

No data available

No data is available for this block.

Enrollment

20Estimated

Arms/Interventions Module

Arm Groups

Label	Type	Description	Intervention Names
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

Name	Type	Description	Arm Group Labels	Other Names
V8	Biological	one pill per day either V8 or placebo	Placebo 850 mg V8 850 mg

Outcomes Module

Primary Outcomes

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

Secondary Outcomes

Not provided

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

Inclusion Criteria:

Baseline level of creatinine twice above normal

Exclusion Criteria:

Baseline level of creatinine normal

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

Not provided

Standard Ages

ChildAdultOlder Adult

Study Population

Not provided

Sampling Method

Not provided

Contacts/Locations Module

Central Contacts

Name	Role	Phone	Extension	Email
Aldar Bourinbaiar, MD/PhD	Contact	13014760930		aldar@immunitor.com
Marina Tarakanovskaya, MD	Contact	+97695130306		info@immunitor.com

Overall Officials

Not provided

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Immunitor LLC		Ulaanbaatar			Mongolia

Condition Browse Module

MeSH Terms

ID	Term
D051436	Renal Insufficiency, Chronic

Ancestor Terms

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases

Browse Leaves

Not provided

Browse Branches

Not provided