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

NCT03456999 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: CMAU868X2201
• Study Type: interventional
• Target: N/A
• Locations: 0 countries
• Sites: N/A

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.

Conditions

BK Virus Nephropathy

Keywords

BKV, renal transplant, renal and kidney transplant

Outcome Measures

Primary Outcomes (1)

• Incidence of BK viremia

  \>1000 copies/mL through 24 weeks

  24 weeks

Secondary Outcomes (2)

• Pharmacokinetics of MAU868

  48 weeks

• Immunogenicity of MAU868

  48 weeks

Study Arms (2)

MAU868

ACTIVE COMPARATOR

BKV-specific, pan-serotype neutralizing antibody

Biological: MAU868

Placebo

PLACEBO COMPARATOR

Matching placebo

Biological: Placebo

Interventions

MAU868 BIOLOGICAL

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

MAU868

Placebo BIOLOGICAL

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

Placebo

Eligibility Criteria

• Age: 7 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• Recipients of organs from identical twins or living, HLA-matched, related donors.
• 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.

Sponsors & Collaborators

• Novartis Pharmaceuticals: lead

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Masking Details: This is a patient, investigator and sponsor-blinded study. Patients and investigators will remain blinded to study treatment throughout the study,
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Model Details: 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.

Study Record Dates

• First Submitted: March 1, 2018
• First Posted: March 7, 2018
• Study Start: October 15, 2018
• Primary Completion: July 13, 2020
• Study Completion: November 16, 2020
• Last Updated: December 13, 2018

Record last verified: 2018-12