Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
| Status: | Recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease |
| Therapuetic Areas: | Nephrology / Urology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 1/3/2019 |
| Start Date: | February 1, 2017 |
| End Date: | December 2020 |
| Contact: | Raymond T Chung, MD |
| Email: | rchung@partners.org |
| Phone: | 6177247562 |
A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Proof of concept, open-label single center study for the donation of HCV positive kidneys to
HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission
upon transplantation.
HCV negative patients, with preemptive, interventional treatment to prevent HCV transmission
upon transplantation.
The study objective is to determine if the administration of grazoprevir and elbasvir (with
or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV
infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative
recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment
or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV
infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative
recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment
Inclusion Criteria:
1. Must meet MGH transplant center criteria and already be listed for isolated kidney
transplant
2. No available living kidney donor
3. Has ≤ 730 days (two years) of accrued transplant waiting time if blood type A and ≤
1095 days of accrued transplant waiting time if blood type B or O.
4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate
<15mL/min/1.73m2 at the time of screening
5. Weight ≥ 50kg
6. Serum ALT within normal limits
Exclusion Criteria:
1. AB blood type
2. BMI > 35
3. History of liver disease
4. Pregnant or nursing (lactating) women
5. Cardiomyopathy (LV ejection fraction < 50%)
6. Positive crossmatch or positive donor specific antibodies
7. HIV positive
8. HCV RNA positive
9. HBV surface antigen positive
10. Any contraindication to kidney transplant per MGH center protocol
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Principal Investigator: Raymond T Chung, MD
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