Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors

NCT04575896 | Completed Phase 4 Results FDA Drug

• 1 other identifier: IRB00237097
• Study Type: interventional
• Target: 10
• 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 2 weeks post-renal transplant.

Conditions

End Stage Renal Disease; Hepatitis C

Outcome Measures

Primary Outcomes (1)

• Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA

  This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment (Number of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ)).

  12 weeks after completing therapy

Study Arms (1)

Deceased donor HCV RNA PCR+

EXPERIMENTAL

Participants who receive a kidney from HCV RNA PCR + deceased donor will receive glecaprevir/pibrentasvir 300 mg/120 mg once daily by mouth for 2 weeks

Drug: Glecaprevir/pibrentasvir

Interventions

Glecaprevir/pibrentasvir DRUG

Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.

Also known as: Mavyret

Deceased donor HCV RNA PCR+

Eligibility Criteria

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

You may qualify if:

• Participants ≥ 18 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 (CKD) 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 antigens (anti-HLA) antibody (flow 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)
• History of prior solid organ transplant other than first kidney 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 Hospital

Baltimore, Maryland, 21205, United States

Location

Related Publications (1)

• Durand CM, Barnaba B, Yu S, Brown DM, Chattergoon MA, Bair N, Naqvi FF, Sulkowski M, Segev DL, Desai NM. Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study. Ann Intern Med. 2021 Jan;174(1):137-138. doi: 10.7326/M20-1468. Epub 2020 Sep 8. No abstract available.

  PMID: 32894697 RESULT

MeSH Terms

Conditions

Kidney Failure, Chronic; Hepatitis C

Interventions

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

Limitations and Caveats

Our study is limited by the small sample size and single-group design.

Results Point of Contact

• Title: Niraj Desai, MD
• Organization: Johns Hopkins University

ndesai13@jhmi.edu

410-614-8297

Study Officials

• Niraj Desai, 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: September 29, 2020
• First Posted: October 5, 2020
• Study Start: November 20, 2020
• Primary Completion: November 28, 2023
• Study Completion: December 1, 2023
• Last Updated: January 10, 2024
• Results First Posted: January 10, 2024

Record last verified: 2024-01

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)