Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant
| Status: | Withdrawn |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 40 - 70 |
| Updated: | 12/22/2018 |
| Start Date: | October 1, 2018 |
| End Date: | January 31, 2021 |
Use of Direct-acting Antiviral Therapy to Prevent Spread of HCV Infection for Patients Receiving a HCV Positive Kidney Transplant as a HCV Negative Recipient
Open label single center study for the donation of HCV positive kidneys to HCV negative
recipients with interventional treatment to prevent HCV transmission upon transplantation.
recipients with interventional treatment to prevent HCV transmission upon transplantation.
The study objective is to determine if the administration of direct acting antivirals for
12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor
kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by
a negative HCV viral RNA at 12 weeks post treatment.
12-16 weeks after kidney transplantation prevents the spread of HCV infection from donor
kidney with known HCV infection (all genotypes) to an HCV negative recipient as evidenced by
a negative HCV viral RNA at 12 weeks post treatment.
Inclusion Criteria:
- Donor meets MGH transplant center criteria and already listed for isolated kidney
transplant
- No available living kidney donor
- Recipient has ≤ 730 days of accrued transplant waiting time
- Recipient chronic hemodialysis or peritoneal dialysis
- Recipient must agree to birth control.
°.Weigh ≥ 50kg
- Serum ALT within normal limits
- Subject's Insurance company approves payment for DAA therapy post-kidney transplant
Exclusion Criteria:
- AB Blood type
- HCV genotype 1
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
- Known allergy or intolerance to tacrolimus that would require administration of
cyclosporine
- Albumin < 3g/dl or
- Platelet count < 75 x 103/mL
- Positive crossmatch or positive donor specific antibodies
- HCV RNA positive
- Hepatitis B surface antigen positive
- Patients with primary focal segmental glomerulosclerosis (FSGS)
- Any contra-indication to kidney transplantation per our center protocol
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