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A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

Primary Purpose

BK Virus Infection

Status
Completed
Phase
Phase 2
Locations
International
Study Type
Interventional
Intervention
MAU868
Placebo
Sponsored by
Vera Therapeutics, Inc.
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for BK Virus Infection

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

  • University of Alabama at Birmingham
  • Cedars-Sinai Medical Center
  • Yale University
  • University of Kentucky
  • The Johns Hopkins University
  • Massachusetts General Hospital
  • Washington University
  • Montefiore Medical Center
  • University Hospitals Cleveland Medical Center
  • University of Pittsburgh Medical Center (UPMC)
  • Vanderbilt University Medical Center
  • Renal Disease Research Institute, LLC
  • The University of Texas Southwester Medical Center
  • Houston Methodist Research Institute
  • University of Washington
  • University Health Network
  • Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
  • The Research Institute of the McGill University Health Centre

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm Type

Experimental

Experimental

Experimental

Placebo Comparator

Arm Label

Cohort 1

Cohort 2

Cohort 3

Placebo Cohort 1, 2, 3

Arm Description

Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses

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

Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses

5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses

Outcomes

Primary Outcome Measures

Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.

Secondary Outcome Measures

Full Information

First Posted
February 26, 2020
Last Updated
June 5, 2023
Sponsor
Vera Therapeutics, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT04294472
Brief Title
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
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)
Study Type
Interventional

2. Study Status

Record Verification Date
February 2023
Overall Recruitment Status
Completed
Study Start Date
August 5, 2020 (Actual)
Primary Completion Date
February 10, 2022 (Actual)
Study Completion Date
February 10, 2022 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Vera Therapeutics, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
BK Virus Infection

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 2
Interventional Study Model
Parallel Assignment
Masking
ParticipantCare ProviderInvestigator
Allocation
Randomized
Enrollment
30 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cohort 1
Arm Type
Experimental
Arm Description
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
Arm Title
Cohort 2
Arm Type
Experimental
Arm Description
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
Arm Title
Cohort 3
Arm Type
Experimental
Arm Description
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
Arm Title
Placebo Cohort 1, 2, 3
Arm Type
Placebo Comparator
Arm Description
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
Intervention Type
Drug
Intervention Name(s)
MAU868
Intervention Description
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
Intervention Type
Other
Intervention Name(s)
Placebo
Intervention Description
250 mL D5W placebo IV to be labeled to match that of MAU868
Primary Outcome Measure Information:
Title
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
Description
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Time Frame
Study Week 1 - Study Week 36
Title
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)
Description
The efficacy of MAU868 in treating BK viremia will be measured primarily by measuring the BK Viral Load in the plasma over time.
Time Frame
Study Week 1 - Study Week 36

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility 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.
Facility Information:
Facility Name
University of Alabama at Birmingham
City
Birmingham
State/Province
Alabama
ZIP/Postal Code
35294-0111
Country
United States
Facility Name
Cedars-Sinai Medical Center
City
Los Angeles
State/Province
California
ZIP/Postal Code
90048
Country
United States
Facility Name
Yale University
City
New Haven
State/Province
Connecticut
ZIP/Postal Code
06511
Country
United States
Facility Name
University of Kentucky
City
Lexington
State/Province
Kentucky
ZIP/Postal Code
40506
Country
United States
Facility Name
The Johns Hopkins University
City
Baltimore
State/Province
Maryland
ZIP/Postal Code
21205
Country
United States
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02241
Country
United States
Facility Name
Washington University
City
Saint Louis
State/Province
Missouri
ZIP/Postal Code
63130
Country
United States
Facility Name
Montefiore Medical Center
City
Bronx
State/Province
New York
ZIP/Postal Code
10467
Country
United States
Facility Name
University Hospitals Cleveland Medical Center
City
Cleveland
State/Province
Ohio
ZIP/Postal Code
44106
Country
United States
Facility Name
University of Pittsburgh Medical Center (UPMC)
City
Pittsburgh
State/Province
Pennsylvania
ZIP/Postal Code
15213
Country
United States
Facility Name
Vanderbilt University Medical Center
City
Nashville
State/Province
Tennessee
ZIP/Postal Code
37232
Country
United States
Facility Name
Renal Disease Research Institute, LLC
City
Dallas
State/Province
Texas
ZIP/Postal Code
75235
Country
United States
Facility Name
The University of Texas Southwester Medical Center
City
Dallas
State/Province
Texas
ZIP/Postal Code
75390
Country
United States
Facility Name
Houston Methodist Research Institute
City
Houston
State/Province
Texas
ZIP/Postal Code
77030
Country
United States
Facility Name
University of Washington
City
Seattle
State/Province
Washington
ZIP/Postal Code
98195
Country
United States
Facility Name
University Health Network
City
Toronto
State/Province
Ontario
ZIP/Postal Code
M5G 2C4
Country
Canada
Facility Name
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H1T 2M4
Country
Canada
Facility Name
The Research Institute of the McGill University Health Centre
City
Montréal
State/Province
Quebec
ZIP/Postal Code
H4A 3J1
Country
Canada

12. IPD Sharing Statement

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A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

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