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Completed

NCT Number: NCT02945150

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

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.

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Key information

Conditions

Renal Failure Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

40 year–70 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

The study objective is to determine if the administration of grazoprevir and elbasvir (with or without ribavirin) for 12-16 weeks after kidney transplantation prevents the spread of HCV infection from a donor kidney with known HCV genotype 1 or 4 infection to a HCV negative recipient as evidenced by a negative HCV viral RNA at 12 weeks post treatment

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

  • 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

Exclusion criteria

  • 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

Treatment and study plan

elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination)

Drug

Elbasvir (50mg) / grazoprevir (100mg) (fixed dose combination) treatment for Hepatitis C virus (HCV)-naive recipients who receive a kidney transplant from a deceased, HCV-infected donor

Subjects receive first dose on-call to operating room, and continue daily for 12 weeks. Treatment length is extended to 16 weeks and ribavirin (daily dose 1000 mg for those <75 kg and 1200 mg for those ≥75 kg) if subject receives a kidney from a donor who is infected with HCV containing resistance-associated variants (RAV).

Other names: Zepatier

Primary outcomes

  1. Number of Participants With Undetectable HCV RNA at SVR12

    Time frame: 12 weeks post-treatment (24 weeks post-transplant)

    Sustained virologic response at 12-weeks post-treatment (SVR12), as defined by negative HCV viral load, after 12-16 weeks of elbasvir/grazoprevir treatment in patients who receive a kidney transplant from a deceased donor infected with HCV.

Secondary outcomes

  1. Number of Subjects With Undetectable Serum HCV RNA at Study Day 7, 14, 28, 56, 84, 112, 168, 252, 365

    Time frame: 1 year post transplant

    Subjects had Hepatitis C viral load assessed at each study visit. Here we looked at the proportion of subjects with undetectable serum HCV RNA at study day 7, 14, 28, 56, 84, 112, 168, 252, 365.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • Merck Sharp & Dohme LLC

Registry information

Official study title

A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant

Important dates

Study start
2017
Primary completion
2019
Study completion
2020
First posted
Oct 26, 2016
Registry last updated
Jun 9, 2020

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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