Kidney Transplant Preemptive Therapy or Prophylaxis for CMV Prevention in D+R- Recipients (KPoP)

Purpose of this Study

People in this study will be placed into one of two groups by chance. One group will receive preventive antiviral medicine after their kidney transplant. The other group will receive regular blood testing and treatment only if signs of CMV infection appear. Both approaches are currently recommended for preventing CMV infection after kidney transplant. Participants will have blood tests every three months during the first year and then once a year after that. These tests will check kidney function, blood cell counts, and the body's ability to fight CMV. Researchers want to learn which prevention strategy works best and is safest for kidney transplant recipients.

Who Can Participate?

Eligibility

People can join this study if they are 18 years old or older and received a kidney transplant within the past 7 days from a donor who tested positive for CMV. They cannot have received more than one organ transplant and cannot have a known immune system disorder or HIV infection. Researchers are studying the best way to prevent CMV infection and its complications after kidney transplant.

Age Range

18-110

Sex/Genders

Male (cisgender)
Female (cisgender)
Non-binary or gender fluid
Transgender male
Transgender female
Looking for Healthy Participants
No

What is Involved?

Description

This study is looking at the best way to prevent a common virus called cytomegalovirus (CMV) from causing problems after a kidney transplant. Researchers are comparing two recommended prevention methods. One method uses antiviral medicine to help prevent CMV infection, and the other uses regular testing and treatment only if signs of infection appear. Participants will have blood tests over time to check for CMV, monitor kidney health, and measure how well their immune system responds to the virus. The goal is to learn which approach is more effective and safer for people who receive a kidney transplant.

Locations

Duke University Hospital

Visit Timing

Weekdays

Compensation

Yes

Spanish Materials Available

Yes

Study Details

Full Title

Kidney Transplant Preemptive Therapy or Prophylaxis for
CMV Prevention in D+R- Recipients (KPoP)

Principal Investigator

Scott
Sanoff

Protocol Number

PRO00120080

Phase

N/A

Enrollment Status

Pending Open to Enrollment