Trials / Withdrawn
WithdrawnNCT03456999
Determine the Safety, Tolerability, and Efficacy of MAU868 for the Prevention of BK Virus Infection in Kidney Transplant Recipients
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
- Status
- Withdrawn
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 0 (actual)
- Sponsor
- Novartis Pharmaceuticals · Industry
- Sex
- All
- Age
- 7 Years
- Healthy volunteers
- Not accepted
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.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| BIOLOGICAL | MAU868 | MAU868 infused i.v. over 1 hour. One dose will be administered monthly for a total of 6 doses. |
| 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 |
Timeline
- Start date
- 2018-10-15
- Primary completion
- 2020-07-13
- Completion
- 2020-11-16
- First posted
- 2018-03-07
- Last updated
- 2018-12-13
Regulatory
- FDA-regulated drug study
Source: ClinicalTrials.gov record NCT03456999. Inclusion in this directory is not an endorsement.