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

NCT ID: NCT03456999

Last Updated: 2018-12-13

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

PHASE2

Study Classification

INTERVENTIONAL

Study Start Date

2018-10-15

Study Completion Date

2020-11-16

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.

Conditions

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BK Virus Nephropathy

Keywords

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BKV, renal transplant, renal and kidney transplant

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

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.
Primary Study Purpose

PREVENTION

Blinding Strategy

TRIPLE

Participants Investigators Outcome Assessors
This is a patient, investigator and sponsor-blinded study. Patients and investigators will remain blinded to study treatment throughout the study,

Study Groups

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MAU868

BKV-specific, pan-serotype neutralizing antibody

Group Type ACTIVE_COMPARATOR

MAU868

Intervention Type BIOLOGICAL

MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses.

Placebo

Matching placebo

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type BIOLOGICAL

Solution containing no active excipients, infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses

Interventions

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MAU868

MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses.

Intervention Type BIOLOGICAL

Placebo

Solution containing no active excipients, infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses

Intervention Type BIOLOGICAL

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.
Minimum Eligible Age

7 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Novartis Pharmaceuticals

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Other Identifiers

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CMAU868X2201

Identifier Type: -

Identifier Source: org_study_id