Recruiting

Kidney Transplantation

Sponsor:

Johns Hopkins University

Code:

NCT06263426

Conditions

Hiv

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Interventions

HIV D+/R+

HIV D-/R+

Study Details

Brief summary:

This research is being done to better understand rejection in transplant recipients with HIV who receive kidneys from donors with vs without HIV.

Conditions

Hiv

Study ID

NCT06263426

Start date

May 22, 2024

Status verified date

Jun, 2026

Completion date

Sep, 2029

Anticipated

Primary completion date

Sep, 2028

Anticipated

Eligibility Criteria

Eligibility Criteria

Sex: All

Age: 18+

Healthy Volunteers: Not accepted

Inclusion Criteria:

  • Participant meets local criteria for kidney transplant.
  • Participant is able to understand and provide informed consent.
  • Participant has documented HIV infection by any licensed assay or documented history of detectable HIV-1 RNA.
  • Participant is ≥ 18 years old.
  • HIV-1 RNA < 50 copies/mL. Viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements > 200 copies/mL.
  • Participant is not suffering from significant wasting (e.g. body mass index <21) thought to be related to HIV disease.

Exclusion Criteria:

  • Participant has prior progressive multifocal leukoencephalopathy (PML), cryptosporidiosis of > 1 month, or primary central nervous system (CNS) lymphoma.
  • Participant is pregnant or breastfeeding.
  • Past or current medical problems or findings from medical history, physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose additional risks from participation in the study, may interfere with the participant's ability to comply with study requirements or that may impact the quality or interpretation of the data obtained from the study.

Study Design

Enrollment

200 participants

Anticipated

Allocation

Non randomized

Intervention Model

Parallel Assignment

Primary purpose

Treatment

Interventions and Outcome Measures

Arms

experimental: HIV D+/R+

People living with HIV who receive kidneys from deceased donors with HIV

experimental: HIV D-/R+

People living with HIV who receive kidneys from deceased donors without HIV

Interventions

HIV D+/R+

Receipt of kidney transplant from a deceased donor with HIV.

HIV D-/R+

Receipt of kidney transplant from a deceased donor without HIV.

Primary outcome measure

  • Cumulative incidence of death and allograft rejection. [ Time Frame: From date of transplant to end of year 1 ]

Central Contacts and Locations

Central contacts

Christine Durand, MD

410-614-6702cdurand2@jhmi.edu

Locations

University of Alabama at Birmingham

Recruiting

Birmingham, Alabama, United States, 35294

Contacts

Shikha Mehta, MD

smehta@uabmc.edu

Principal Investigator:

Shikha Mehta, MD

University of California, Davis

Recruiting

Sacramento, California, United States, 95817

Contacts

Sana J Shaikh, MD

sjshaikh@health.ucdavis.edu

Principal Investigator:

Sana J Shaikh, MD

University of California, San Diego

Recruiting

San Diego, California, United States, 92037

Contacts

Saima Aslam, MBBS

saslam@ucsd.edu

Principal Investigator:

Saima Aslam, MBBS

University of California, San Francisco

Recruiting

San Francisco, California, United States, 94143

Contacts

Garrett Roll, MD

Garrett.Roll@ucsf.edu

Principal Investigator:

Garrett Roll, MD

Mayo Clinic Florida

Recruiting

Jacksonville, Florida, United States, 32224

Contacts

Shennen A Mao, MD

Mao.Shennen@mayo.edu

Principal Investigator:

Shennen A Mao, MD

Northwestern University

Recruiting

Chicago, Illinois, United States, 60611

Contacts

Valentina Stosor, MD

v-stosor@northwestern.edu

Principal Investigator:

Valentina Stosor, MD

Rush University Medical Center

Recruiting

Chicago, Illinois, United States, 60612

Contacts

Carlos Santos, MD

Carlos_A_Santos@rush.edu

Principal Investigator:

Carlos Santos, MD

Ochsner Clinic Foundation

Recruiting

New Orleans, Louisiana, United States, 70121

Contacts

Jonathan Hand, MD

jonathan.hand@ochsner.org

Principal Investigator:

Jonathan Hand, MD

Johns Hopkins University

Recruiting

Baltimore, Maryland, United States, 21205

Contacts

Christine Durand, MD

cdurand2@jhmi.edu

Principal Investigator:

Christine Durand, MD

Massachusetts General Hospital

Recruiting

Boston, Massachusetts, United States, 02114

Contacts

Nahel Elias, MD

elias.nahel@mgh.harvard.edu

Principal Investigator:

Nahel Elias, MD

Washington University St. Louis Barnes Jewish Hospital

Recruiting

St Louis, Missouri, United States, 63110

Contacts

Ige George, MD, MS

igegeorge@wustl.edu

Principal Investigator:

Ige George, MD, MS

New York University

Recruiting

New York, New York, United States, 10016

Contacts

Sapna Mehta, MD

Sapna.mehta@nyumc.org

Principal Investigator:

Sapna Mehta, MD

Icahn School of Medicine at Mt. Sinai

Recruiting

New York, New York, United States, 10029

Contacts

Sander Florman, MD

Sander.florman@mountsinai.org

Principal Investigator:

Sander Florman, MD

Columbia University

Recruiting

New York, New York, United States, 10032

Principal Investigator:

Marcus Pereira, MD

University of Pennsylvania

Recruiting

Philadelphia, Pennsylvania, United States, 19104

Contacts

Emily Blumberg, MD

eblumber@pennmedicine.upenn.edu

Principal Investigator:

Emily Blumberg, MD

University of Pittsburgh Medical Center

Recruiting

Pittsburgh, Pennsylvania, United States, 15213

Contacts

Ghady Haidar, MD

haidarg@upmc.edu

Principal Investigator:

Ghady Haidar, MD

Houston Methodist Research Institute

Recruiting

Houston, Texas, United States, 77030

Contacts

Kevin Grimes, MD, MPH

kagrimes@houstonmethodist.org

Principal Investigator:

Kevin Grimes, MD, MPH

More Information

Sponsor

Johns Hopkins University

Last update posted

Jun 22, 2026

Last verified

Jun, 2026

Trial information was received from ClinicalTrials.gov and was last updated on 2026-09-08. This information was provided to ClinicalTrials.gov by Johns Hopkins University on 2026-06-22.