- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT03456999
Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients
December 11, 2018 updated by: Novartis Pharmaceuticals
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
This study is being conducted to determine whether MAU868 warrants further clinical development for the prevention of BKV infection in kidney transplant recipients.
Study Overview
Status
Withdrawn
Conditions
Intervention / Treatment
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 Type
Interventional
Phase
- Phase 2
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
5 years and older (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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.
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Prevention
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Triple
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Placebo Comparator: Placebo
Matching placebo
|
Solution containing no active excipients, infused i.v. over 1 hour.
One dose will be administered monthly for a total of 6 doses
|
Active Comparator: MAU868
BKV-specific, pan-serotype neutralizing antibody
|
MAU868 infused i.v. over 1 hour.
One dose will be administered monthly for a total of 6 doses.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Incidence of BK viremia
Time Frame: 24 weeks
|
>1000 copies/mL through 24 weeks
|
24 weeks
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
Pharmacokinetics of MAU868
Time Frame: 48 weeks
|
Cmin
|
48 weeks
|
Immunogenicity of MAU868
Time Frame: 48 weeks
|
Investigate the potential development of anti-drug antibodies
|
48 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Sponsor
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start (Anticipated)
October 15, 2018
Primary Completion (Anticipated)
July 13, 2020
Study Completion (Anticipated)
November 16, 2020
Study Registration Dates
First Submitted
March 1, 2018
First Submitted That Met QC Criteria
March 1, 2018
First Posted (Actual)
March 7, 2018
Study Record Updates
Last Update Posted (Actual)
December 13, 2018
Last Update Submitted That Met QC Criteria
December 11, 2018
Last Verified
December 1, 2018
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CMAU868X2201
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Yes
Studies a U.S. FDA-regulated device product
No
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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