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Trial record 1 of 2 for:    MAU868
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A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT04294472
Recruitment Status : Completed
First Posted : March 4, 2020
Results First Posted : May 24, 2023
Last Update Posted : May 24, 2023
Sponsor:
Information provided by (Responsible Party):
Vera Therapeutics, Inc.

Study Description
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Brief Summary:
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.

Condition or disease Intervention/treatment Phase
BK Virus Infection Drug: MAU868 Other: Placebo Phase 2

Study Design
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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 30 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Official Title: A Randomized, Double-blind, Placebo-controlled Study to Assess the Safety, Pharmacokinetics and Efficacy of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients (Neutra4)
Actual Study Start Date : August 5, 2020
Actual Primary Completion Date : February 10, 2022
Actual Study Completion Date : February 10, 2022

Resource links provided by the National Library of Medicine


Arms and Interventions
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Arm Intervention/treatment
Experimental: Cohort 1
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
 Drug: MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Experimental: Cohort 2
Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses
 Drug: MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Experimental: Cohort 3
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
 Drug: MAU868
MAU868 is a human monoclonal antibody (IgG1) that binds the viral capsid protein, VP1, that is responsible for binding to the surface of host cells
Placebo Comparator: Placebo Cohort 1, 2, 3
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
 Other: Placebo
250 mL D5W placebo IV to be labeled to match that of MAU868


Outcome Measures
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Primary Outcome Measures :
  1. Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log [ Time Frame: Study Week 1 - Study Week 36 ]
    The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.

  2. Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) [ Time Frame: Study Week 1 - Study Week 36 ]
    The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Be a male or female 18 years of age or older.
  • Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment
  • Documented BKV viremia based on local or central laboratory testing within 10 days

Exclusion Criteria:

  • A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.
  • A BKV plasma viral load of ≥ 10^7 copies/mL.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT04294472


Locations
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Sponsors and Collaborators
Vera Therapeutics, Inc.
  Study Documents (Full-Text)

Documents provided by Vera Therapeutics, Inc.:
Study Protocol  [PDF] April 15, 2020
Statistical Analysis Plan  [PDF] May 27, 2021

More Information
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Responsible Party: Vera Therapeutics, Inc.
ClinicalTrials.gov Identifier: NCT04294472    
Other Study ID Numbers: MAU868-201
First Posted: March 4, 2020    Key Record Dates
Results First Posted: May 24, 2023
Last Update Posted: May 24, 2023
Last Verified: February 2023

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Viremia
Virus Diseases
Infections
Sepsis
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes