drugset / Trial / NCT04294472
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
RandomizedParallel-groupTriple-blindTreatment
Summary
This clinical research study will test the safety and efficacy of the investigational medication MAU868, compared to a placebo, in patients who have had a kidney transplant who have active BK virus.
Timeline
- Start
- 2020-08-05
- Primary completion
- 2022-02-10
- Completion
- 2022-02-10
Outcome
Missed primary endpoint
registry analysis (superiority test); Placebo vs Active Arm (Cohort 1); p = 0.1866; Log Rank NCT04294472 ↗
registry analysis (superiority test); Placebo vs Active Arm (Cohort 2); p = 0.2627; Log Rank NCT04294472 ↗
registry analysis (superiority test); Placebo vs Active Arm (Cohort 1); p = 0.0639; Log Rank NCT04294472 ↗
registry analysis (superiority test); Placebo vs Active Arm (Cohort 2); p = 0.0508; Log Rank NCT04294472 ↗
Publications
- Wajih Z, Karpe KM, Walters GD. Interventions for BK virus infection in kidney transplant recipients. Cochrane Database Syst Rev. 2024 Oct 9;10(10):CD013344. doi: 10.1002/14651858.CD013344.pub2.
- Helle F, Aubry A, Morel V, Descamps V, Demey B, Brochot E. Neutralizing Antibodies Targeting BK Polyomavirus: Clinical Importance and Therapeutic Potential for Kidney Transplant Recipients. J Am Soc Nephrol. 2024 Oct 1;35(10):1425-1433. doi: 10.1681/ASN.0000000000000457. Epub 2024 Jul 9.
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | TRAXIVITUG | Protein / enzyme biologic | 1350 mg | Intravenous |
| Subject | TRAXIVITUG | Protein / enzyme biologic | 6750 mg | Intravenous |