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

NCT03627299 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00174409
• Study Type: interventional
• Target: 11
• Locations: 1 country
• Sites: 1

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.

Conditions

End Stage Renal Disease; Hepatitis C

Outcome Measures

Primary Outcomes (2)

• Viral Response at Week 12

  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

  12 weeks after completing therapy

• Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P

  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.

  4 weeks after transplant

Secondary Outcomes (9)

• Viral Response at 1 Week

  1 week after completing therapy

• Viral Response at 2 Weeks

  2 weeks after completing therapy

• Viral Response at 4 Weeks

  4 weeks after completing therapy

• Viral Response at 8 Weeks

  8 weeks after completing therapy

• Antibody Development

  week 12 after discontinuation of therapy

Study Arms (1)

Deceased donor HCV RNA PCR+

EXPERIMENTAL

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

Interventions

300mg glecaprevir/pibrentasivir 120mg DRUG

300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant

Also known as: Mavyret

Deceased donor HCV RNA PCR+

Eligibility Criteria

• Age: 40 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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%

You may not qualify if:

• 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

Sponsors & Collaborators

• Johns Hopkins University: lead

Study Sites (1)

Johns Hopkins University

Baltimore, Maryland, 21205, United States

Location

MeSH Terms

Conditions

Kidney Failure, Chronic; Hepatitis C

Interventions

glecaprevir; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Results Point of Contact

• Title: Christine Durand, MD
• Organization: Johns Hopkins University

ChristineDurand@jhmi.edu

410-955-5684

Study Officials

• Christine Durand, MD

  Johns Hopkins University

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: August 8, 2018
• First Posted: August 13, 2018
• Study Start: September 25, 2018
• Primary Completion: December 19, 2019
• Study Completion: September 20, 2021
• Last Updated: October 19, 2021
• Results First Posted: August 24, 2020

Record last verified: 2021-09

Locations

US (1)