Live Kidney Donors With Positive Anti-HCV Antibody, But Negative HCV PCR
1 other identifier
interventional
2
1 country
1
Brief Summary
It is well recognized that a subset of patients who contracts Hepatitis C virus (HCV) spontaneously clears the virus. Such individuals are anti-HCV antibody positive, yet HCV RNA PCR negative in the blood. While they have not been considered candidates for live kidney donation in the past, with the recent availability of novel anti-HCV drugs with \>95% cure rates, they now represent a potential pool of donor candidates, especially since the risk for transmission of HCV to the recipient is extremely low. The investigators goal is to demonstrate that live kidney donation from anti-HCV positive, HCV RNA PCR negative individuals is safe and carries a negligible risk of viral transmission to the recipient.
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at below P25 for not_applicable
Started Mar 2016
Longer than P75 for not_applicable
1 active site
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 27, 2016
CompletedFirst Posted
Study publicly available on registry
February 1, 2016
CompletedStudy Start
First participant enrolled
March 1, 2016
CompletedPrimary Completion
Last participant's last visit for primary outcome
February 1, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
February 1, 2020
CompletedFebruary 19, 2020
February 1, 2020
3.9 years
January 27, 2016
February 17, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Maintenance of HCV seronegativity
At 3 months post-transplant, recipients will be screened for HCV seropositivity. A negative seropositive result will conclude the recipient's participation in the study
3 months
Study Arms (1)
Study Arm
EXPERIMENTALDonor candidates with their intended recipients who meet criteria will be enrolled into this, the sole arm of our study. Donor-recipient pairs will be screened to meet criteria, and will proceed to kidney transplantation and post-transplant monitoring
Interventions
Once the donor and recipient candidates have met inclusion criteria and cleared study-specific as well as standard of care screening, they will proceed to live-donor kidney transplantation and subsequent post-transplant monitoring
Eligibility Criteria
You may qualify if:
- The donor candidate must be anti-HCV positive by ELISA and HCV RNA negative by PCR, with both tests repeated for confirmation, as per standard protocol.
- The donor must be evaluated and cleared by Hepatology, which is currently the standard of care for HCV seropositive individuals.
- The donor must meet criteria for living kidney donation and be approved by the UF Health Shands Kidney Transplant Medical Review Board.
- The recipient may be HCV antibody negative or anti-HCV antibody positive but HCV RNA negative by PCR.
- The recipient must meet the criteria for kidney transplantation and be approved by the UF Health Kidney Transplant Program Medical Review Board.
Contact the study team to confirm eligibility.
Sponsors & Collaborators
Study Sites (1)
Shands at the University of Florida
Gainesville, Florida, 32610, United States
Related Publications (6)
Afdhal N, Zeuzem S, Kwo P, Chojkier M, Gitlin N, Puoti M, Romero-Gomez M, Zarski JP, Agarwal K, Buggisch P, Foster GR, Brau N, Buti M, Jacobson IM, Subramanian GM, Ding X, Mo H, Yang JC, Pang PS, Symonds WT, McHutchison JG, Muir AJ, Mangia A, Marcellin P; ION-1 Investigators. Ledipasvir and sofosbuvir for untreated HCV genotype 1 infection. N Engl J Med. 2014 May 15;370(20):1889-98. doi: 10.1056/NEJMoa1402454. Epub 2014 Apr 11.
PMID: 24725239BACKGROUNDSchold J, Srinivas TR, Sehgal AR, Meier-Kriesche HU. Half of kidney transplant candidates who are older than 60 years now placed on the waiting list will die before receiving a deceased-donor transplant. Clin J Am Soc Nephrol. 2009 Jul;4(7):1239-45. doi: 10.2215/CJN.01280209. Epub 2009 Jun 18.
PMID: 19541814BACKGROUNDCruzado JM, Gil-Vernet S, Castellote J, Bestard O, Melilli E, Grinyo JM. Successful treatment of chronic HCV infection should not preclude kidney donation to an HCV negative recipient. Am J Transplant. 2013 Oct;13(10):2773-4. doi: 10.1111/ajt.12400. Epub 2013 Aug 6. No abstract available.
PMID: 23919533BACKGROUNDBaid-Agrawal S, Schindler R, Reinke P, Staedtler A, Rimpler S, Malik B, Frei U, Berg T. Prevalence of occult hepatitis C infection in chronic hemodialysis and kidney transplant patients. J Hepatol. 2014 May;60(5):928-33. doi: 10.1016/j.jhep.2014.01.012. Epub 2014 Jan 18.
PMID: 24447875BACKGROUNDHalfon P, Martinot-Peignoux M, Cacoub P. The myth of occult hepatitis C infection. Hepatology. 2009 Nov;50(5):1675. doi: 10.1002/hep.23113. No abstract available.
PMID: 19585649BACKGROUNDReddy KR EG, Flamm SL, et al. Ledipasvir/sofosbuvir with ribavirin for the treatment of HCV in patients with post-transplant recurrence: preliminary results of a prospective, multicenter study. Hepatology. 2014;60:200A.
BACKGROUND
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Intervention Hierarchy (Ancestors)
Study Officials
- PRINCIPAL INVESTIGATOR
Karl Womer, MD
Univesity of Florida
Study Design
- Study Type
- interventional
- Phase
- not applicable
- Allocation
- NA
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- SINGLE GROUP
- Sponsor Type
- OTHER
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 27, 2016
First Posted
February 1, 2016
Study Start
March 1, 2016
Primary Completion
February 1, 2020
Study Completion
February 1, 2020
Last Updated
February 19, 2020
Record last verified: 2020-02
Data Sharing
- IPD Sharing
- Will not share