Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

Withdrawn before enrolling · Phase 4

Conditions studied: Renal Failure Chronic, Hepatitis C

In brief

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.

Key facts

Study ID

NCT03093740

Run by

Massachusetts General Hospital

People needed

0

Starts

2018-10-01

Expected to finish

2021-01-31

Last updated by the study team

2018-12-20

Who can join

Age: 40 and older, up to 70. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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

You may not qualify if…

• 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

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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