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

Primary Purpose

BK Virus Nephropathy

Status

Withdrawn

Phase

Phase 2

Locations

Study Type

Interventional

Intervention

MAU868

Placebo

About this trial

This is an interventional prevention trial for BK Virus Nephropathy focused on measuring BKV, renal transplant, renal and kidney transplant

Eligibility Criteria

7 Years - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Placebo Comparator

Arm Label

MAU868

Placebo

Arm Description

BKV-specific, pan-serotype neutralizing antibody

Matching placebo

Outcomes

Primary Outcome Measures

Incidence of BK viremia

>1000 copies/mL through 24 weeks

Secondary Outcome Measures

Pharmacokinetics of MAU868

Cmin

Immunogenicity of MAU868

Investigate the potential development of anti-drug antibodies

Full Information

NCT ID

NCT03456999

First Posted

March 1, 2018

Last Updated

December 11, 2018

Sponsor

Novartis Pharmaceuticals

1. Study Identification

Unique Protocol Identification Number

NCT03456999

Brief Title

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

Official Title

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

Study Type

Interventional

2. Study Status

Record Verification Date

December 2018

Overall Recruitment Status

Withdrawn

Why Stopped

company decision

Study Start Date

October 15, 2018 (Anticipated)

Primary Completion Date

July 13, 2020 (Anticipated)

Study Completion Date

November 16, 2020 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Novartis Pharmaceuticals

4. Oversight

Studies a U.S. FDA-regulated Drug Product

Yes

Studies a U.S. FDA-regulated Device Product

Data Monitoring Committee

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

BK Virus Nephropathy

Keywords

BKV, renal transplant, renal and kidney transplant

7. Study Design

Primary Purpose

Prevention

Study Phase

Phase 2

Interventional Study Model

Parallel Assignment

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

ParticipantInvestigatorOutcomes Assessor

Masking Description

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

Allocation

Randomized

Enrollment

0 (Actual)

8. Arms, Groups, and Interventions

Arm Title

MAU868

Arm Type

Active Comparator

Arm Description

BKV-specific, pan-serotype neutralizing antibody

Arm Title

Placebo

Arm Type

Placebo Comparator

Arm Description

Matching placebo

Intervention Type

Biological

Intervention Name(s)

MAU868

Intervention Description

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

Intervention Type

Biological

Intervention Name(s)

Placebo

Intervention Description

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

Primary Outcome Measure Information:

Title

Incidence of BK viremia

Description

>1000 copies/mL through 24 weeks

Time Frame

24 weeks

Secondary Outcome Measure Information:

Title

Pharmacokinetics of MAU868

Description

Cmin

Time Frame

48 weeks

Title

Immunogenicity of MAU868

Description

Investigate the potential development of anti-drug antibodies

Time Frame

48 weeks

10. Eligibility

Sex

All

Minimum Age & Unit of Time

7 Years

Accepts Healthy Volunteers

Eligibility Criteria

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.

12. IPD Sharing Statement

Learn more about this trial

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

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