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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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ClinicalTrials.gov Identifier: NCT04294472
Recruitment Status : Recruiting
First Posted : March 4, 2020
Last Update Posted : January 29, 2021
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

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)
Estimated Enrollment : 36 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
Estimated Primary Completion Date : February 2023
Estimated Study Completion Date : May 2023

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 12 ]
    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 12 ]
    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


Contacts
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Contact: Sara H Barbat 858-345-1755 sbarbat@amplyx.com

Locations
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United States, Alabama
University of Alabama at Birmingham Not yet recruiting
Birmingham, Alabama, United States, 35294-0111
Contact: Nathan Erdmann, MD       nberdmann@uabmc.edu   
United States, Connecticut
Yale University Recruiting
New Haven, Connecticut, United States, 06511
Contact: William S Asch, MD       william.asch@yale.edu   
United States, Kentucky
University of Kentucky Recruiting
Lexington, Kentucky, United States, 40506
Contact: Roberto Gedaly, MD       rgeda2@uky.edu   
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02241
Contact: Kassem Safa, MD       kassem.safa@mgh.harvard.edu   
United States, Missouri
Washington University Recruiting
Saint Louis, Missouri, United States, 63130
Contact: Rowena Delos Santos, MD       delossantos@wustl.edu   
United States, New York
Montefiore Medical Center Recruiting
Bronx, New York, United States, 10467
Contact: Enver Akalin, MD       eakalin@montefiore.org   
United States, Ohio
University Hospitals Cleveland Medical Center Recruiting
Cleveland, Ohio, United States, 44106
Contact: Titte R Srinivas, MD       Titte.Srinivas@UHhospitals.org   
United States, Pennsylvania
University of Pittsburgh Medical Center (UPMC) Recruiting
Pittsburgh, Pennsylvania, United States, 15213
Contact: Puneet Sood, MD       soodp2@upmc.edu   
United States, Tennessee
Vanderbilt University Medical Center Recruiting
Nashville, Tennessee, United States, 37232
Contact: Beatrice P Concepcion, MD       beatrice.p.concepcion@vumc.org   
United States, Texas
Renal Disease Research Institute, LLC Recruiting
Dallas, Texas, United States, 75235
Contact: Bernard Fischbach, MD       fischbachb@DNEPH.com   
The University of Texas Southwester Medical Center Recruiting
Dallas, Texas, United States, 75390
Contact: David Wojciechowski, D.O.       David.Wojciechowski@UTSouthwestern.edu   
Houston Methodist Research Institute Recruiting
Houston, Texas, United States, 77030
Contact: Ahmed O Gaber, MD       aogaber@houstonmethodist.org   
United States, Washington
University of Washington Recruiting
Seattle, Washington, United States, 98195
Contact: Cynthia Fisher, MD       celaine@uw.edu   
Canada, Ontario
University Health Network Recruiting
Toronto, Ontario, Canada, M5G 2C4
Contact: Deepali Kumar, MD       deepali.kumar@uhn.ca   
Canada, Quebec
Centre intégré universitaire de santé et de services sociaux (CIUSSS) de l'Est de-l'Île-de-Montréal Recruiting
Montréal, Quebec, Canada, H1T 2M4
Contact: Suzon Colette, MD       suzoncollette@gmail.com   
The Research Institute of the McGill University Health Centre Recruiting
Montréal, Quebec, Canada, H4A 3J1
Contact: Matthew P Cheng, MD       matthew.cheng@mcgill.ca   
Sponsors and Collaborators
Amplyx Pharmaceuticals
More Information
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Responsible Party: Amplyx Pharmaceuticals
ClinicalTrials.gov Identifier: NCT04294472    
Other Study ID Numbers: MAU868-201
First Posted: March 4, 2020    Key Record Dates
Last Update Posted: January 29, 2021
Last Verified: January 2021

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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
Sepsis
 Systemic Inflammatory Response Syndrome
Inflammation
Pathologic Processes