Back to resultsImmunotherapy of Chronic Kidney Failure
Primary Purpose
Renal Failure Chronic
Status
Unknown status
Phase
Phase 2
Locations
Mongolia
Study Type
Interventional
Intervention
V8
Sponsored by
About this trial
This is an interventional treatment trial for Renal Failure Chronic
Eligibility Criteria
Inclusion Criteria:
- Baseline level of creatinine twice above normal
Exclusion Criteria:
- Baseline level of creatinine normal
Sites / Locations
- Immunitor LLC
Arms of the Study
Arm 1
Arm 2
Arm Type
Experimental
Placebo Comparator
Arm Label
V8 850 mg
Placebo 850 mg
Arm Description
Arm 1: Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of V8
Arm: 2 Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of placebo
Outcomes
Primary Outcome Measures
Effect on creatinine
Change in serum creatinine level from baseline
Secondary Outcome Measures
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT04377243
Brief Title
Immunotherapy of Chronic Kidney Failure
Official Title
Phase II Trial of V8 in Treating Kidney Failure
Study Type
Interventional
2. Study Status
Record Verification Date
May 2020
Overall Recruitment Status
Unknown status
Study Start Date
June 16, 2020 (Anticipated)
Primary Completion Date
May 15, 2021 (Anticipated)
Study Completion Date
September 1, 2021 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Immunitor LLC
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Failure Chronic
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare Provider
Masking Description
neither patients nor attending physician are aware
Allocation
Randomized
Enrollment
20 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
V8 850 mg
Arm Type
Experimental
Arm Description
Arm 1: Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of V8
Arm Title
Placebo 850 mg
Arm Type
Placebo Comparator
Arm Description
Arm: 2 Individuals with chronic kidney failure having creatinine level twice higher than normal. They will receive once daily pill of placebo
Intervention Type
Biological
Intervention Name(s)
V8
Other Intervention Name(s)
Placebo
Intervention Description
one pill per day either V8 or placebo
Primary Outcome Measure Information:
Title
Effect on creatinine
Description
Change in serum creatinine level from baseline
Time Frame
1 month
10. Eligibility
Sex
All
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
Baseline level of creatinine twice above normal
Exclusion Criteria:
Baseline level of creatinine normal
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Aldar Bourinbaiar, MD/PhD
Phone
13014760930
Email
aldar@immunitor.com
First Name & Middle Initial & Last Name or Official Title & Degree
Marina Tarakanovskaya, MD
Phone
+97695130306
Email
info@immunitor.com
Facility Information:
Facility Name
Immunitor LLC
City
Ulaanbaatar
Country
Mongolia
12. IPD Sharing Statement
Learn more about this trial
Immunotherapy of Chronic Kidney Failure
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