A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients

• Status: Recruiting
• Trial end date: 2023-05-01
• Target enrollment: 0
• Participant gender: All

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.

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Amplyx Pharmaceuticals

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.