Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
| Status: | Not yet recruiting |
|---|---|
| Conditions: | Renal Impairment / Chronic Kidney Disease, Renal Impairment / Chronic Kidney Disease, Hepatitis, Hepatitis |
| Therapuetic Areas: | Immunology / Infectious Diseases, Nephrology / Urology |
| Healthy: | No |
| Age Range: | 30 - 70 |
| Updated: | 12/22/2018 |
| Start Date: | February 15, 2019 |
| End Date: | April 15, 2021 |
| Contact: | Raymond T Chung, MD |
| Email: | RChung@partners.org |
| Phone: | 6177247532 |
Pan-genotypic Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
This is a proof of concept, single center study for the donation of HCV-positive kidney to
HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of
commercially available DAA therapy to prevent HCV transmission upon transplantation.
HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of
commercially available DAA therapy to prevent HCV transmission upon transplantation.
The goal of this study is to determine if preoperative dosing and sustained administration of
pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis
C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.
pan-genotypic DAA therapy after kidney transplantation prevents the transmission of hepatitis
C virus (HCV) infection from an HCV positive donor kidney to an HCV naïve recipient.
Inclusion Criteria:
- Met MGH transplant center criteria and already listed for kidney transplant
- No available living kidney donor
- 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.
- On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate
<15mL/min/1.73m2 at the time of screening
- Must agree to birth control. Women must agree to use birth control in accordance with
Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
- Weigh at least 50kg
- Serum ALT within normal limits with no history of liver disease
- Able to sign informed consent
Exclusion Criteria:
- AB blood type
- BMI > 35
- Any liver disease in recipient
- Pregnant or nursing (lactating) women
- Known allergy or intolerance to tacrolimus that would require administration of
cyclosporine rather than tacrolimus given the known drug-drug interaction between
cyclosporine and Mavyret
- Cardiomyopathy (LV ejection fraction < 50%)
- Albumin < 3g/dl or platelet count < 75 x 103/mL
- Positive donor specific antibodies or positive cross match deemed to be clinically
relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- Positive donor specific antibodies or positive cross match deemed to be clinically
relevant and increasing risk of rejection per the transplant surgeon or nephrologist
- HCV RNA positive
- Hepatitis B surface antigen positive
- Any known liver disease or elevated liver transaminases
- Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after
previous transplant, or disease process with increased risk of causing early graft
failure as assessed by the transplant nephrologist and/or the investigator team
- Any contra-indication to kidney transplantation per MGH center protocol
- Patients on the following medications who cannot stop therapy: carbamazepine,
rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.
We found this trial at
1
site
185 Cambridge Street
Boston, Massachusetts 02114
Boston, Massachusetts 02114
617-724-5200
Phone: 617-724-3836
Click here to add this to my saved trials
