Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Completed · Phase 4

Conditions studied: Renal Failure

In brief

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.

Key facts

Study ID

NCT02945150

Run by

Massachusetts General Hospital

People needed

8

Starts

2017-02-01

Expected to finish

2020-03-05

Last updated by the study team

2020-06-09

Who can join

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

You may qualify if…

• Must meet Massachusetts General Hospital (MGH) transplant center criteria and already be listed for isolated 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
• Weight ≥ 50kg
• Serum alanine transaminase (ALT) within normal limits

You may not qualify if…

• AB blood type
• Body mass index (BMI > 35
• History of liver disease
• Pregnant or nursing (lactating) women
• Cardiomyopathy (LV ejection fraction < 50%)
• Positive crossmatch or positive donor specific antibodies
• Human immunodeficiency virus (HIV) positive
• Hepatitis C virus (HCV) RNA positive
• Hepatitis B virus (HBV) surface antigen positive
• Any contraindication to kidney transplant per MGH center protocol

Where it is running

• Massachusetts General Hospital — Boston, Massachusetts, United States

Full record on ClinicalTrials.gov

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