A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
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.
- BK Virus Infection
- Eligible Ages
- Over 18 Years
- Eligible Genders
- Accepts Healthy Volunteers
- 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
- 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.
- Phase 2
- Study Type
- Intervention Model
- Parallel Assignment
- Primary Purpose
- Triple (Participant, Care Provider, Investigator)
|Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses||
|Cohort 2: MAU868 6750 mg IV on Study Day 1 and then 1350 mg IV approximately every 28 days for a total of 4 doses||
|Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses||
Placebo Cohort 1, 2, 3
|5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses||
UK Center for Clinical and Translational Science and nearby locations
- NCT ID
- Amplyx Pharmaceuticals
Study ContactSara H Barbat