Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant
Withdrawn before enrolling · Phase 4
Conditions studied: Kidney Failure, Kidney Diseases, Hepatitis C
In brief
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.
Key facts
- Study ID
- NCT03623568
- Run by
- Raymond T. Chung, MD
- People needed
- 0
- Starts
- 2019-02-15
- Expected to finish
- 2021-04-15
- Last updated by the study team
- 2019-06-03
Who can join
Age: 30 and older, up to 70. Sex: any. Healthy volunteers: not accepted.
You may qualify if…
- 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
You may not qualify if…
- 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.
Where it is running
- Massachusetts General Hospital — Boston, Massachusetts, United States
Full record on ClinicalTrials.gov
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