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

Vera Therapeutics

Status and phase: Completed; Phase 2

Conditions: BK Virus Infection

Treatments: Other: Placebo; Drug: MAU868

Study type: Interventional

Funder types: Industry

Identifiers

NCT04294472

MAU868-201

Details and patient eligibility

About

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.

Enrollment: 30 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Triple Blind

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30 participants in 4 patient groups, including a placebo group

Cohort 1

Experimental group

Description:

Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses

Treatment:

Drug: MAU868

Cohort 2

Experimental group

Description:

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

Treatment:

Drug: MAU868

Cohort 3

Experimental group

Description:

Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses

Treatment:

Drug: MAU868

Placebo Cohort 1, 2, 3

Placebo Comparator group

Description:

5% dextrose in water \[D5W\] IV delivered every 28 days for a total of 4 doses

Treatment:

Other: Placebo