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

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ClinicalTrials.gov Identifier: NCT02945150
Recruitment Status : Recruiting
First Posted : October 26, 2016
Last Update Posted : December 29, 2017
Sponsor:
Collaborator:
Merck Sharp & Dohme Corp.
Information provided by (Responsible Party):
Raymond T. Chung, MD, Massachusetts General Hospital

Brief Summary:
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.

Condition or disease Intervention/treatment Phase
Renal Failure Drug: grazoprevir plus elbasvir (fixed dose combination) Phase 4

Detailed Description:
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

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 40 participants
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Prevention
Official Title: A Proof of Concept Study of Preemptive Treatment With Grazoprevir and Elbasvir for Donor HCV Positive to Recipient HCV Negative Kidney Transplant
Actual Study Start Date : February 1, 2017
Estimated Primary Completion Date : December 2018
Estimated Study Completion Date : December 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Treatment with grazoprevir plus elbasvir
12 to 16 weeks of treatment with grazoprevir plus elbasvir
Drug: grazoprevir plus elbasvir (fixed dose combination)
HCV treatment for 12 to 16 weeks. Treatment length based upon presence of baseline resistance associated variant in the HCV virus
Other Name: Zepatier




Primary Outcome Measures :
  1. Undetectable HCV [ Time Frame: 12 weeks post treatment ]
    Negative HCV viral RNA at 12 weeks after the last dose of treatment.


Secondary Outcome Measures :
  1. Safety and tolerability of grazoprevir and elbasvir (with or without ribavirin) in patients who have undergone kidney transplantation [ Time Frame: Upto 16 weeks ]
    Safety and tolerability of grazoprevir and elbasvir in the kidney transplant patient will be monitored by quantifying the number of treatment related adverse events per patient and evaluating out of range laboratory results as compared to baseline/pretreatment values per patient.



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Ages Eligible for Study:   40 Years to 70 Years   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Must meet MGH transplant center criteria and already be listed for isolated kidney transplant
  2. No available living kidney donor
  3. 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.
  4. On chronic hemodialysis or peritoneal dialysis or has a glomerular filtration rate <15mL/min/1.73m2 at the time of screening
  5. Weight ≥ 50kg
  6. Serum ALT within normal limits

Exclusion Criteria:

  1. AB blood type
  2. BMI > 35
  3. History of liver disease
  4. Pregnant or nursing (lactating) women
  5. Cardiomyopathy (LV ejection fraction < 50%)
  6. Positive crossmatch or positive donor specific antibodies
  7. HIV positive
  8. HCV RNA positive
  9. HBV surface antigen positive
  10. Any contraindication to kidney transplant per MGH center protocol

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02945150


Contacts
Contact: Raymond T Chung, MD 6177247562 rchung@partners.org
Contact: Jenna L Gustafson, MS 6177243836 JLGustafson@partners.org

Locations
United States, Massachusetts
Massachusetts General Hospital Recruiting
Boston, Massachusetts, United States, 02114
Contact: Donald Chute, BA       LiverResearchGroup@partners.org   
Principal Investigator: Raymond T Chung, MD         
Sub-Investigator: Meghan E Sise, MD         
Sponsors and Collaborators
Massachusetts General Hospital
Merck Sharp & Dohme Corp.
Investigators
Principal Investigator: Raymond Chung, MD Massachusetts General Hospital (Partners Healthcare)

Publications:
Responsible Party: Raymond T. Chung, MD, Director, Hepatology, Massachusetts General Hospital, Massachusetts General Hospital
ClinicalTrials.gov Identifier: NCT02945150     History of Changes
Other Study ID Numbers: 2016P002051
Merck MISP 54841 ( Other Grant/Funding Number: Merck )
First Posted: October 26, 2016    Key Record Dates
Last Update Posted: December 29, 2017
Last Verified: December 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: Data will be shared with study sponsor and with the hopes of publication.
Supporting Materials: Study Protocol
Time Frame: Protocol will be shared for up to 1 year after the final patient has dosed.
Access Criteria: Protocol will only be shared with IRB approved study staff and PI approved collaborators.

Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Product Manufactured in and Exported from the U.S.: No

Keywords provided by Raymond T. Chung, MD, Massachusetts General Hospital:
hemodialysis
peritoneal dialysis
renal failure
kidney transplant

Additional relevant MeSH terms:
Renal Insufficiency
Kidney Diseases
Urologic Diseases