Trial Outcomes & Findings for BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients (NCT NCT01782209)

NCT ID: NCT01782209

Last Updated: 2020-07-28

Results Overview

We will measure the number of subjects screened who develops BK viremia within 4 weeks and up to 24 months after renal transplant

• Recruitment status: COMPLETED
• Target enrollment: 335 participants
• Primary outcome timeframe: within 4 weeks and up to 24 months after renal transplant
• Results posted on: 2020-07-28

Participant Flow

Participant milestones

Measure	Renal Transplant Patients Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Overall Study STARTED	335
Overall Study COMPLETED	225
Overall Study NOT COMPLETED	110

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

BK Virus Infection (Viremia) Natural History in Renal Transplant Recipients

Baseline characteristics by cohort

Measure	Renal Transplant Patients n=335 Participants Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Age, Continuous	49 Years STANDARD_DEVIATION 13.1 • n=5 Participants
Sex: Female, Male Female	150 Participants n=5 Participants
Sex: Female, Male Male	185 Participants n=5 Participants
Ethnicity (NIH/OMB) Hispanic or Latino	22 Participants n=5 Participants
Ethnicity (NIH/OMB) Not Hispanic or Latino	313 Participants n=5 Participants
Ethnicity (NIH/OMB) Unknown or Not Reported	0 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	2 Participants n=5 Participants
Race (NIH/OMB) Asian	11 Participants n=5 Participants
Race (NIH/OMB) Native Hawaiian or Other Pacific Islander	3 Participants n=5 Participants
Race (NIH/OMB) Black or African American	100 Participants n=5 Participants
Race (NIH/OMB) White	214 Participants n=5 Participants
Race (NIH/OMB) More than one race	3 Participants n=5 Participants
Race (NIH/OMB) Unknown or Not Reported	2 Participants n=5 Participants
Region of Enrollment United States	335 participants n=5 Participants

PRIMARY outcome

Timeframe: within 4 weeks and up to 24 months after renal transplant

We will measure the number of subjects screened who develops BK viremia within 4 weeks and up to 24 months after renal transplant

Outcome measures

Measure	Renal Transplant Patients n=335 Participants Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Incidence of BKV Viremia in the Study Population of Screened Renal or Renal-pancreas Transplant Subjects	58 Participants

Adverse Events

Renal Transplant Patients

Serious events: 0 serious events

Other events: 1 other events

Deaths: 4 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Measure	Renal Transplant Patients n=335 participants at risk Male and female renal or renal-pancreas transplant recipients at risk for BK virus infection
Injury, poisoning and procedural complications Bruising on left arm	0.30% 1/335 • Number of events 1 • 24 months

Additional Information

Richard J. Whitley, MD

University of Alabama at Birmingham

Phone: 205.638.2530

Email: rwhitley@peds.uab.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place