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Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients

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ClinicalTrials.gov Identifier: NCT03408106
Recruitment Status : Recruiting
First Posted : January 23, 2018
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Tracking Information
First Submitted Date January 17, 2018
First Posted Date January 23, 2018
Last Update Posted Date January 21, 2019
Actual Study Start Date August 1, 2017
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: January 17, 2018)
Adverse events [ Time Frame: at 1 year ]
incidence of adverse events related to nephrectomy
Original Primary Outcome Measures Same as current
Change History Complete list of historical versions of study NCT03408106 on ClinicalTrials.gov Archive Site
Current Secondary Outcome Measures
 (submitted: January 17, 2018)
  • chronic kidney disease [ Time Frame: through to study completion, up to 4 years ]
    time to significant proteinuria or glomerular filtration rate below 60 ml/min
  • hypertension [ Time Frame: through to study completion, up to 4 years ]
    time to hypertension defined as systolic blood pressure > 140 mm Hg confirmed
  • change in antiretroviral therapy [ Time Frame: through to study completion, up to 4 years ]
    proportion of participants requiring change in antiretroviral therapy
  • HIV virologic control [ Time Frame: through to study completion, up to 4 years ]
    proportion of participants with HIV virologic failure or breakthrough
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Official Title Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Brief Summary Prospective Clinical Trial of HIV+ Living Donor Kidney Donation for HIV+ Recipients
Detailed Description This is a prospective study to evaluate the safety of donor nephrectomy in HIV+ individuals who donate kidneys to HIV+ candidates in need of transplant . The study will assess potential complications of HIV + living donors - including adverse events related to nephrectomy, development of chronic kidney disease, hypertension, and HIV-related complications.
Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Retention:   Samples With DNA
Description:
Blood, tissue
Sampling Method Non-Probability Sample
Study Population HIV+ patients 21 years of age or older
Condition HIV Infections
Intervention Not Provided
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Recruiting
Estimated Enrollment
 (submitted: January 17, 2018)
20
Original Estimated Enrollment Same as current
Estimated Study Completion Date December 31, 2022
Estimated Primary Completion Date August 1, 2022   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • Able to understand and provide consent
  • Age 21 years or older
  • Meets standard clinical criteria for living donation per Johns Hopkins University (JHU) Comprehensive Transplant Center Policy
  • Documented HIV infection (by any licensed Enzyme-linked Immunosorbent Assay (ELISA) and confirmation by Western Blot, positive HIV Ab Immunofluorescent Assay (IFA), or documented history of detectable HIV-1 RNA)
  • CD4+ T-cell count ≥ 500/µL for 6 months prior to donation
  • HIV-1 RNA below 50 copies RNA/mL (viral blips between 50-400 copies will be allowed as long as there are not consecutive measurements >200 copies/mL)

Exclusion Criteria:

  • Two high risk alleles of APOL1 (G1 or G2 variants)
  • Hypertension
  • Diabetes
  • Chronic active hepatitis C (detectable HCV RNA in plasma)
  • Evidence of invasive opportunistic complications from HIV infection
  • Mentally incompetent and/or inability to provide informed consent
  • Other medical conditions, as determined by the provider, that would preclude donation
Sex/Gender
Sexes Eligible for Study: All
Ages 21 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts
Contact: Christine Durand, MD 410-955-5684 cdurand2@jhmi.edu
Contact: Dorry Segev, MD, PhD 401-502-6115 dorry@jhmi.edu
Listed Location Countries United States
Removed Location Countries  
 
Administrative Information
NCT Number NCT03408106
Other Study ID Numbers IRB00138153
Has Data Monitoring Committee Yes
U.S. FDA-regulated Product
Studies a U.S. FDA-regulated Drug Product: No
Studies a U.S. FDA-regulated Device Product: No
IPD Sharing Statement Not Provided
Responsible Party Johns Hopkins University
Study Sponsor Johns Hopkins University
Collaborators Not Provided
Investigators
Principal Investigator: Christine Durand, MD Johns Hopkins University
PRS Account Johns Hopkins University
Verification Date January 2019