Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients
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|ClinicalTrials.gov Identifier: NCT03249194|
Recruitment Status : Active, not recruiting
First Posted : August 15, 2017
Last Update Posted : November 28, 2018
|Condition or disease||Intervention/treatment||Phase|
|Kidney Transplant Hepatitis C||Drug: Direct acting Anti-Viral Therapy using Epclusa or Zepatier||Early Phase 1|
Traditionally, HCV+ kidneys are not offered to HCV- patients on the waiting list. The primary concern with offering HCV+ kidneys to HCV- recipients is a risk of viral transmission. Although data about the long-term impact of HCV+ kidney transplantation in to HCV- recipients is unclear, there was a clear suggestion of an increased risk of liver disease in these patients based upon studies performed in the 1990s. Traditional therapy with Interferon could not be offered to these patients as it can lead of rejection if kidney transplant. It was recently reported that nearly 65% (out of a total 6546) of all HCV+ kidneys were discarded between the years 2005-2014. These kidneys were otherwise of excellent quality and could have benefitted more than 4000 patients with 12,000 plus years of graft life.
Since the recent FDA approval of Direct Acting Anti-virals (DAA), these drugs have now been shown to be safe and efficacious even in the setting of kidney transplant. They could offer a unique opportunity to expand the kidney donor pool. For this study, the investigators hypothesize that pre-emptive treatment with a direct acting anti-viral HCV medication to cure HCV soon after transplant would allow for safe transplantation of HCV+ kidneys in disadvantaged and needy HCV- kidney recipients with acceptable risks and improved survivals compared with historical cohorts. This novel study will develop pilot data on the safety and efficacy of utilizing HCV+ kidneys in high-risk HCV- recipients in order to expand the donor pool and reduce the morbidity and mortality of hemodialysis.
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||25 participants|
|Intervention Model:||Single Group Assignment|
|Masking:||None (Open Label)|
|Official Title:||Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients: A Novel Application of Direct-Acting Antiviral Drugs|
|Actual Study Start Date :||August 17, 2017|
|Estimated Primary Completion Date :||June 30, 2019|
|Estimated Study Completion Date :||June 30, 2022|
Experimental: HCV+ Donor Kidney Recipient
All HCV- participants who receive an HCV+ donor kidney transplant will receive a first 'on-call' dose of Epclusa (sofosbuvir/velpatasvir; Gilead) and then three more doses on post-operative Day 1, 2 and 3. Donor HCV Genotype data will be available by Day 7 of transplant.
Patients will then be followed by serial HCV PCRs. Patients who are HCV PCR positive by Day 14 will be treated with Epclusa once daily x 12 weeks.
Drug: Direct acting Anti-Viral Therapy using Epclusa or Zepatier
All patients will receive one 'on-call' dose of SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead) immediately prior to transplant and one dose on post-operative Day 1 post-transplant. Patients who develop detectable HCV viremia will be initiated on Direct Acting Anti-viral (DAA) therapy between 2-4 weeks post-transplant. Patients with GT1 will be treated with ELBASVIR/GRAZOPREVIR (Zepatier, Merck) and those with GT2 or 3 will be treated with SOFOSBUVIR/VELPATASVIR (Epclusa, Gilead) based upon donor genotyping results
Other Name: Epclusa, Zepatier
- Sustained Virologic Response (SVR) [ Time Frame: 12 weeks ]Among the patients who develop HCV viremia SVR rates with DAA will be measured
- Graft and Patient Survival [ Time Frame: 1 year ]Age and co-morbidity will matched historical HCV- recipients as controls. Patient survival will also be compared to a contemporary cohort of wait listed patients who declined enrollment due to personal choice
- Sustained Virologic Response (SVR) Follow Up 1 [ Time Frame: 24 weeks ]Among the patients who develop HCV viremia SVR rates with DAA will be measured
- Sustained Virologic Response (SVR) Follow Up 2 [ Time Frame: 48 weeks ]Among the patients who develop HCV viremia SVR rates with DAA will be measured
- Liver Disease [ Time Frame: 1 year ]Among patients who develop HCV viremia liver disease progression will be measured using non-invasive panels like fibroscan
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03249194
|United States, Virginia|
|Virginia Commonwealth University|
|Richmond, Virginia, United States, 23298|
|Principal Investigator:||Gaurav Gupta, MD||Virginia Commonwealth University|