Phase 2
N=30
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
BK Virus Infection
Bottom Line
View on ClinicalTrials.gov: NCT04294472 ↗Enrolled (actual)
30
Serious AEs
50.0%
Results posted
May 2023
Primary outcome: Primary: Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log — 19.61; 10.80; 18.25 Weeks — p=0.1866
Study Design & Population
- Study type
- Interventional
- Phase
- Phase 2
- Interventions
- MAU868 (Drug); Placebo (Other)
- Age
- Adult, Older Adult · 18+ yrs
- Sex
- All
- Sponsor
- Vera Therapeutics, Inc.
- Primary completion
- Feb 2022
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log |
19.61; 10.80; 18.25 | 0.1866 |
| PRIMARY Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ) |
NA; 16.79; 8.18 | 0.0639 |
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.
Eligibility Criteria
Inclusion Criteria
- Be a male or female 18 years of age or older.
- Recipient of a kidney (or kidney-pancreas) transplant within the year prior to enrollment
- Documented BKV viremia based on local or central laboratory testing within 10 days
Exclusion Criteria
- A BKV plasma viral load which has exceeded 10^3 copies/mL for >4 months.
- A BKV plasma viral load of ≥ 10^7 copies/mL.
Data sourced from ClinicalTrials.gov (NCT04294472). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.