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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 : April 26, 2021
Sponsor:
Information provided by (Responsible Party):
Amplyx Pharmaceuticals

Tracking Information
First Submitted Date  ICMJE February 26, 2020
First Posted Date  ICMJE March 4, 2020
Last Update Posted Date April 26, 2021
Actual Study Start Date  ICMJE August 5, 2020
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: March 2, 2020)
  • 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.
  • 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.
Original Primary Outcome Measures  ICMJE Same as current
Change History
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
Official Title  ICMJE 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)
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.
Detailed Description Not Provided
Study Type  ICMJE Interventional
Study Phase  ICMJE Phase 2
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Triple (Participant, Care Provider, Investigator)
Primary Purpose: Treatment
Condition  ICMJE BK Virus Infection
Intervention  ICMJE
  • 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
  • Other: Placebo
    250 mL D5W placebo IV to be labeled to match that of MAU868
Study Arms  ICMJE
  • Experimental: Cohort 1
    Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
    Intervention: Drug: MAU868
  • 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
    Intervention: Drug: MAU868
  • Experimental: Cohort 3
    Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
    Intervention: Drug: MAU868
  • Placebo Comparator: Placebo Cohort 1, 2, 3
    5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
    Intervention: Other: Placebo
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Recruiting
Estimated Enrollment  ICMJE
 (submitted: March 2, 2020)
36
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE May 2023
Estimated Primary Completion Date February 2023   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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.
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE
Contact: Sara H Barbat 858-345-1755 sbarbat@amplyx.com
Listed Location Countries  ICMJE Canada,   United States
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT04294472
Other Study ID Numbers  ICMJE MAU868-201
Has Data Monitoring Committee Not Provided
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement  ICMJE Not Provided
Responsible Party Amplyx Pharmaceuticals
Study Sponsor  ICMJE Amplyx Pharmaceuticals
Collaborators  ICMJE Not Provided
Investigators  ICMJE Not Provided
PRS Account Amplyx Pharmaceuticals
Verification Date April 2021

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP