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

Phase 2

Withdrawn

• Conditions: BK Virus Nephropathy
• Interventions: Biological: MAU868; Biological: Placebo

• Registration Number: NCT03456999
• Lead Sponsor: Novartis Pharmaceuticals

Brief Summary

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

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.

Study Timeline

• Study First Submitted: 2018-03-01
• Study First Submitted QC: 2018-03-01
• Study First Posted: 2018-03-07
• Study Start: 2018-10-15
• Status Verified: 2018-12
• Last Update Submitted: 2018-12-11
• Last Update Posted: 2018-12-13
• Primary Completion: 2020-07-13
• Study Completion: 2020-11-16

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

Not provided

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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.

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
MAU868	MAU868	BKV-specific, pan-serotype neutralizing antibody
Placebo	Placebo	Matching placebo

Primary Outcome Measures

Name	Time	Method
Incidence of BK viremia	24 weeks	\>1000 copies/mL through 24 weeks

Secondary Outcome Measures

Name	Time	Method
Immunogenicity of MAU868	48 weeks	Investigate the potential development of anti-drug antibodies
Pharmacokinetics of MAU868	48 weeks	Cmin