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Virus Therapy

Cohort 1 for BK Virus Infection

Phase 2
Waitlist Available
Research Sponsored by Amplyx Pharmaceuticals
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up study week 1 - study week 36
Awards & highlights

Study Summary

This trial will test a new drug to see if it's safe and effective in people who have had a kidney transplant and who have the BK virus.

Eligible Conditions
  • BK Virus Infection

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~study week 1 - study week 36
This trial's timeline: 3 weeks for screening, Varies for treatment, and study week 1 - study week 36 for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
Time (Weeks) to Decrease of BKV Plasma Viral Load by 1 Log
Time (Weeks) to First Decrease of BKV Plasma Viral Load to Less Than Lower Limit of Quantification (LLOQ)

Side effects data

From 2022 Phase 2 trial • 30 Patients • NCT04294472
20%
Diabetic ketoacidosis
20%
Urinary tract infection
20%
Nausea
20%
Dizziness
10%
Vitamin D decreased
10%
Microalbuminuria
10%
Gamma-glutamyltransferase increased
10%
BK virus infection
10%
Eye infection
10%
Cytomegalovirus viraemia
10%
Upper respiratory tract infection
10%
Hyperkalaemia
10%
Wrist fracture
10%
Hepatic enzyme increased
10%
Dyspnoea
10%
Cough
10%
Acute myocardial infarction
10%
Urosepsis
10%
Diarrhoea
10%
Acute respiratory failure
10%
Hypotension
10%
Anaemia
10%
Gastrooesophageal reflux disease
10%
Fatigue
10%
Wound
10%
Concussion
10%
Pancreatitis acute
10%
Vomiting
10%
Blood bicarbonate decreased
10%
Bone marrow failure
10%
Corona virus infection
10%
Pneumonia viral
10%
Conjunctival haemorrhage
10%
Aspergillus infection
10%
Cellulitis of male external genital organ
10%
Sinusitis
10%
Tooth infection
10%
Metabolic acidosis
10%
Muscle spasms
10%
Pain in extremity
10%
Headache
10%
Acute kidney injury
10%
Hydronephrosis
10%
Skin ulcer
10%
Haematoma
10%
Hypertension
10%
Thrombosis
100%
80%
60%
40%
20%
0%
Study treatment Arm
Placebo
Active Arm (Cohort 1)
Active Arm (Cohort 2)

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: Cohort 3Experimental Treatment1 Intervention
Cohort 3: MAU868 6750 mg IV approximately every 28 days for a total of 4 doses
Group II: Cohort 2Experimental Treatment1 Intervention
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
Group III: Cohort 1Experimental Treatment1 Intervention
Cohort 1: MAU868 1350 mg IV approximately every 28 days for a total of 4 doses
Group IV: Placebo Cohort 1, 2, 3Placebo Group1 Intervention
5% dextrose in water [D5W] IV delivered every 28 days for a total of 4 doses
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
MAU868
2020
Completed Phase 2
~30

Find a Location

Who is running the clinical trial?

Amplyx PharmaceuticalsLead Sponsor
8 Previous Clinical Trials
363 Total Patients Enrolled
Vera Therapeutics, Inc.Lead Sponsor
2 Previous Clinical Trials
736 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients
2020. "A Safety, Pharmacokinetics and Efficacy Study of MAU868 for the Treatment of BK Viremia in Kidney Transplant Recipients". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04294472.
~6 spots leftby Apr 2025
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