Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients
| Status: | Active, not recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 18 - 80 |
| Updated: | 3/10/2019 |
| Start Date: | August 17, 2017 |
| End Date: | June 30, 2022 |
Hepatitis C Virus Donor Positive Kidney Transplantation for Hepatitis C Virus Negative Recipients: A Trial of Ultra-short Duration Direct Acting Anti-viral Prophylaxis To Prevent Virus Transmission From Hepatitis C Viremic Donors To Hepatitis C Negative Kidney Transplant Recipients (DAPPER)
The development of direct acting anti-virals (DAAs) for the treatment of Hepatitis C virus
(HCV) has changed the landscape of HCV therapy dramatically in the last several years with
reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV
positive patients including those who have received liver or kidney transplants. Since these
new regimens do not include interferon and have already been studied in the post-liver and
kidney transplant setting, they now offer a unique opportunity to expand the donor pool and
improve the lives of those awaiting renal transplant. The address this gap in knowledge, 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
positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable
risks and improved survivals compared with historical cohorts.
(HCV) has changed the landscape of HCV therapy dramatically in the last several years with
reported sustained virologic response (SVR) rates in excess of 95% for treatment-naïve HCV
positive patients including those who have received liver or kidney transplants. Since these
new regimens do not include interferon and have already been studied in the post-liver and
kidney transplant setting, they now offer a unique opportunity to expand the donor pool and
improve the lives of those awaiting renal transplant. The address this gap in knowledge, 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
positive kidneys in disadvantaged and needy HCV negative kidney recipients with acceptable
risks and improved survivals compared with historical cohorts.
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.
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.
Inclusion Criteria:
- No evidence of HCV infection by HCV PCR (done at the time of the initial consent)
- Age>60 yrs with an expected waiting time>2 years; or
- Age<60 yrs with any one of the following risk factors: Diabetes, coronary artery
disease, peripheral artery disease and/or cerebrovascular disease
- Willingness to provide informed consent
- Absence of a living donor.
Exclusion Criteria:
- Estimated life expectancy of less than one year based on clinical judgment of the
investigator
- Prior liver or renal transplantation
- Pregnant women
- Incarcerated patients
- Medical or social condition which in the opinion of the investigator will interfere
with or prevent follow-up per protocol
- Unable or unwilling to return for follow-up visits
Donor Exclusion Criteria:
- HBV sAg positive
- HIV PCR or antibody positive
- HCV RNA negative
We found this trial at
1
site
Virginia Commonwealth University Since our founding as a medical school in 1838, Virginia Commonwealth University...
Click here to add this to my saved trials
