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Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03627299
Recruitment Status : Completed
First Posted : August 13, 2018
Results First Posted : August 24, 2020
Last Update Posted : October 1, 2020
Sponsor:
Information provided by (Responsible Party):
Johns Hopkins University

Brief Summary:
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.

Condition or disease Intervention/treatment Phase
End Stage Renal Disease Hepatitis C Drug: 300mg glecaprevir/pibrentasivir 120mg Phase 4

Detailed Description:

In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.

The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 4 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.

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Study Type : Interventional  (Clinical Trial)
Actual Enrollment : 11 participants
Allocation: N/A
Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: An Open-label Pilot Study to Determine the Safety and Efficacy of Fixed-dose Glecaprevir and Pibrentasvir Treatment in Hepatitis C Uninfected Recipients of Renal Transplants From Hepatitis C Infected Deceased Donors
Actual Study Start Date : September 25, 2018
Actual Primary Completion Date : December 19, 2019
Actual Study Completion Date : August 14, 2020

Resource links provided by the National Library of Medicine


Arm Intervention/treatment
Experimental: Deceased donor HCV RNA PCR+
Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks
Drug: 300mg glecaprevir/pibrentasivir 120mg
300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Other Name: Mavyret




Primary Outcome Measures :
  1. Viral Response at Week 12 [ Time Frame: 12 weeks after completing therapy ]
    This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12

  2. Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P [ Time Frame: 4 weeks after transplant ]
    Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.


Secondary Outcome Measures :
  1. Viral Response at 1 Week [ Time Frame: 1 week after completing therapy ]
    This is the number of participants with undetectable hepatitis C RNA in the blood at 1 week after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 1

  2. Viral Response at 2 Weeks [ Time Frame: 2 weeks after completing therapy ]
    This is the number of participants with undetectable hepatitis C RNA in the blood at 2 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 2

  3. Viral Response at 4 Weeks [ Time Frame: 4 weeks after completing therapy ]
    This is the number of participants with undetectable hepatitis C RNA in the blood at 4 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 4

  4. Viral Response at 8 Weeks [ Time Frame: 8 weeks after completing therapy ]
    This is the number of participants with undetectable hepatitis C RNA in the blood at 8 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 8

  5. Antibody Development [ Time Frame: week 12 after discontinuation of therapy ]
    Number of kidney transplant recipients that become reactive for HCV antibody

  6. T-cell Response at Baseline [ Time Frame: Baseline prior to induction therapy ]
    Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection

  7. T-cell Response at 12 Weeks [ Time Frame: week12 after discontinuation of therapy ]
    Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection

  8. Kidney Function at 6 Months [ Time Frame: 6 months following transplant ]
    Serum creatinine mg/dL at 6 months following transplantation

  9. Kidney Function at 12 Months [ Time Frame: 12 months following transplant ]
    Serum creatinine mg/dL at 12 months following transplantation



Information from the National Library of Medicine

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

Recipient Inclusion Criteria

  • Participants ≥ 40 years old
  • On the deceased donor kidney waitlist at Johns Hopkins Hospital
  • Awaiting a first or second kidney transplant
  • No available living kidney donors
  • On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease defined as a glomerular filtration rate <15 ml/min for ≥ past 90 days
  • HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis
  • Calculated panel reactive anti-human leukocyte antigen antibody (cPRA) below 80%

Recipient Exclusion Criteria

  • Plan to receive a multi-organ transplant
  • Plan to receive a dual kidney transplant (including en bloc)
  • Prior solid organ transplant
  • Participating in another study that involves an intervention or investigational product
  • Plan to receive a blood type incompatible kidney
  • History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA
  • Unable to safely substitute or discontinue a medication that is contraindicated with the study medication
  • Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study

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): NCT03627299


Locations
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United States, Maryland
Johns Hopkins University
Baltimore, Maryland, United States, 21205
Sponsors and Collaborators
Johns Hopkins University
Investigators
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Principal Investigator: Christine Durand, MD Johns Hopkins University
  Study Documents (Full-Text)

Documents provided by Johns Hopkins University:
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Responsible Party: Johns Hopkins University
ClinicalTrials.gov Identifier: NCT03627299    
Other Study ID Numbers: IRB00174409
First Posted: August 13, 2018    Key Record Dates
Results First Posted: August 24, 2020
Last Update Posted: October 1, 2020
Last Verified: September 2020
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided
Plan Description: Peer reviewed publications

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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.: Yes
Additional relevant MeSH terms:
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Hepatitis A
Hepatitis C
Hepatitis
Kidney Failure, Chronic
Liver Diseases
Digestive System Diseases
Hepatitis, Viral, Human
Virus Diseases
Enterovirus Infections
Picornaviridae Infections
RNA Virus Infections
Flaviviridae Infections
Kidney Diseases
Urologic Diseases
Renal Insufficiency, Chronic
Renal Insufficiency