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MIB-626 for Acute Kidney Injury
Phase 2
Waitlist Available
Led By Shalender Bhasin, MD
Research Sponsored by Metro International Biotech, LLC
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up enrollment to 14 days or hospital discharge, or death, whichever comes first
Awards & highlights
Study Summary
This trial will test if a drug can help adults with COVID-19 & kidney injury by improving kidney function & reducing inflammation.
Eligible Conditions
- Acute Kidney Injury
- Coronavirus
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ enrollment to 14 days or hospital discharge, or death, whichever comes first
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~enrollment to 14 days or hospital discharge, or death, whichever comes first
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Change from baseline in serum cystatin C levels
Secondary outcome measures
Change from baseline in intracellular NAD+ concentrations in blood during the 14-day treatment period in a subset of study participants
Change from baseline in markers of endothelial damage (vWF, VCAM, PAI-1)
Change from baseline in markers of microvascular thrombosis (D-dimer, fibrinogen)
+7 moreOther outcome measures
Change from baseline in Modified Sequential Organ Failure Assessment (SOFA) Score (SOFA) Score
Progression in the stage of acute kidney injury increase in serum creatinine OR serum creatinine > 4.0 mg/dL OR need
The WHO 8-point Ordinal Scale of Clinical Status
+5 moreSide effects data
From 2022 Phase 2 trial • 7 Patients • NCT0481711114%
Constipation
14%
Belching
14%
Back pain
14%
Neck pain
14%
Insomnia
100%
80%
60%
40%
20%
0%
Study treatment Arm
Open Label - MIB-626
Trial Design
3Treatment groups
Experimental Treatment
Placebo Group
Group I: MIB-626Experimental Treatment1 Intervention
Oral administration of MIB-626 substantially raises the intracellular NAD+ levels and activates signaling mechanisms that regulate inflammation and cell survival, downregulates the NLRP3 inflammasome, and attenuates the inflammatory response in a number of experimental models, and protects against tissue damage induced by pro-inflammatory cytokines.
Group II: Home TreatmentExperimental Treatment3 Interventions
Participants, who are discharged from the hospital before the completion of the 14-day intervention period, will be provided sufficient study medication to take home with them so they can continue to take the medication twice daily for the remaining duration of the 14-day intervention period.
Group III: Placebo TabletPlacebo Group1 Intervention
A placebo control will be supplied. Participants randomized to placebo will receive matching tablet.
Matching placebo tablets will be provided by the study's Sponsor, Metro International Biotech, LLC.
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MIB-626
2021
Completed Phase 2
~50
Placebo
1995
Completed Phase 3
~2670
Find a Location
Who is running the clinical trial?
Metro International Biotech, LLCLead Sponsor
2 Previous Clinical Trials
127 Total Patients Enrolled
Shalender Bhasin, MDPrincipal InvestigatorBrigham and Women's Hospital
15 Previous Clinical Trials
7,475 Total Patients Enrolled
Frequently Asked Questions
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