Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients

Study Overview
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Brief Summary
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This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.

Detailed Description
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This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible subjects are planned to be randomized 2:1 to receive MAU868 or placebo. At least 78 subjects are expected to complete the study. The study will consist of a pre-treatment (screening) consenting period, a 24 week treatment period (consisting of 6 monthly i.v. doses of MAU868 or placebo) and a 24 week follow-up period. Subjects who complete the study per protocol will attend a total of 16 visits over a period of 48 weeks.

Official Title
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A Randomized, Double Blind, Placebo Controlled Study to Assess the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of Allograft-threatening BK Virus Infection in Kidney Transplant Recipients

Conditions
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BK Virus Nephropathy

Intervention / Treatment
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* Biological: MAU868
* Biological: Placebo


Participation Criteria
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Eligibility Criteria
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Inclusion criteria; Male or female recipients of a first or second kidney or kidney-pancreas transplant who weigh at least 30 kg and are at least 7 years of age (in the US, 18 years of age or above) at the time of transplantation. Recipients of organs from a heart-beating deceased, non-heart-beating deceased, living unrelated, or human leukocyte antigen (HLA)-mismatched living related donor. Recipients who are treated with lymphocyte-depleting induction therapy (e.g., rabbit antithymocyte globulin, alemtuzumab). Subjects treated with rabbit antithymocyte globulin must receive a total dose of at least 3 mg/kg. Subjects treated with alemtuzumab must receive a total dose of at least 20 mg. Recipients of a kidney with a cold ischemia time (CIT) <36 hours. Exclusion Criteria: Recipients of organs from identical twins or living, HLA-matched, related donors. ABO incompatible or complement-dependent lymphocytotoxic (CDC) crossmatch positive transplant (isolated positive B cell crossmatches are not an exclusion criterion). Recipients who are treated with non-lymphocyte-depleting induction therapy (e.g., basiliximab) or no induction therapy. Recipients who are treated or planned to be treated with mTOR inhibitors as part of their initial immunosuppression regimen post-transplantation. Recipients who require antibody-depletion prior to transplantation and in the opinion of the investigator are likely to require antibody-depletion after transplantation. Antibody-depleting therapies include but are not necessarily limited to plasmapharesis, immunoadsorption, and IVIg. Pregnant or nursing (lactating) women, where pregnancy is defined as the state of a female after conception and until the termination of gestation, confirmed by hCG testing. Current clinical, radiographic, or laboratory evidence of active or latent tuberculosis (TB) or any history, in the opinion of the investigator, that confers a risk of reactivation of TB and precludes the use of conventional immunosuppression. History of splenectomy or asplenia. Women of child-bearing potential, defined as all women physiologically capable of becoming pregnant, unless they are using basic methods of contraception during dosing of investigational drug.

Ages Eligible for Study
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Minimum Age: 7 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Prevention
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: This is a non-confirmatory, randomized, placebo-controlled, blinded, proof-of-concept study in kidney transplant recipients. Approximately 96 eligible patients are planned to be randomized 2:1 to receive MAU868 or placebo.
Masking: Triple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Active Comparator: MAU868<br>BKV-specific, pan-serotype neutralizing antibody | Biological: MAU868<br>* MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses.<br>|
| Placebo Comparator: Placebo<br>Matching placebo | Biological: Placebo<br>* Solution containing no active excipients, infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Incidence of BK viremia | >1000 copies/mL through 24 weeks | 24 weeks | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Pharmacokinetics of MAU868 | Cmin | 48 weeks | 
| Immunogenicity of MAU868 | Investigate the potential development of anti-drug antibodies | 48 weeks | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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BKV, renal transplant, renal and kidney transplant