Direct Acting Antiviral Therapy in Donor HCV-positive to Recipient HCV-negative Kidney Transplant

NCT03623568 | Withdrawn Phase 4 FDA Drug

• 1 other identifier: 2018P001077
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

This is a proof of concept, single center study for the donation of HCV-positive kidney to HCV negative recipient patients, with preemptive, interventional treatment with 12 weeks of commercially available DAA therapy to prevent HCV transmission upon transplantation.

Conditions

Kidney Failure; Kidney Diseases; Hepatitis C

Keywords

CKD; HCV; Hepatitis C; Transplant

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV RNA in blood

  Negative HCV viral RNA at 12 weeks after the last dose of treatment as determined by blood test

  12 weeks post treatment

Secondary Outcomes (2)

• Safety (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation)

  12 weeks post treatment

• Tolerability (based on number of adverse events and out of range lab values) of DAA therapy in patients undergoing kidney transplantation

  12 Weeks post treatment

Study Arms (1)

Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV

EXPERIMENTAL

12 weeks of treatment with Mavyret

Drug: glecaprevir/pibrentasvir tablets

Interventions

glecaprevir/pibrentasvir tablets DRUG

12 weeks of treatment with Mavyret

Also known as: Mavyret

Treatment with Mavyret (glecaprevir/pibrentasvir) for HCV

Eligibility Criteria

• Age: 30 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Met MGH transplant center criteria and already listed for 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
• Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
• Weigh at least 50kg
• Serum ALT within normal limits with no history of liver disease
• Able to sign informed consent

You may not qualify if:

• AB blood type
• BMI \> 35
• Any liver disease in recipient
• Pregnant or nursing (lactating) women
• Known allergy or intolerance to tacrolimus that would require administration of cyclosporine rather than tacrolimus given the known drug-drug interaction between cyclosporine and Mavyret
• Cardiomyopathy (LV ejection fraction \< 50%)
• Albumin \< 3g/dl or platelet count \< 75 x 103/mL
• Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
• Positive donor specific antibodies or positive cross match deemed to be clinically relevant and increasing risk of rejection per the transplant surgeon or nephrologist
• HCV RNA positive
• Hepatitis B surface antigen positive
• Any known liver disease or elevated liver transaminases
• Patients with primary focal segmental glomerulosclerosis (FSGS), FSGS recurring after previous transplant, or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or the investigator team
• Any contra-indication to kidney transplantation per MGH center protocol
• Patients on the following medications who cannot stop therapy: carbamazepine, rifampin, St. John's wort, and ethinyl estradiol-containing oral contraceptives.

Sponsors & Collaborators

• Raymond T. Chung, MD: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency; Kidney Diseases; Hepatitis C

Interventions

glecaprevir; pibrentasvir; glecaprevir and pibrentasvir

Condition Hierarchy (Ancestors)

Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Blood-Borne Infections; Communicable Diseases; Infections; Hepatitis, Viral, Human; Virus Diseases; Flaviviridae Infections; RNA Virus Infections; Hepatitis; Liver Diseases; Digestive System Diseases

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR INVESTIGATOR
• PI Title: Director of Hepatology

Study Record Dates

• First Submitted: August 2, 2018
• First Posted: August 9, 2018
• Study Start: February 15, 2019
• Primary Completion: December 31, 2020
• Study Completion: April 15, 2021
• Last Updated: June 3, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL
• Time Frame: Anticipate data would be available to share within 6 months after the final patient completes the study.
• Access Criteria: Coded data would be shared with collaborators who have received IRB approval to use the data and have been approved by the PI for their collaboration.

Locations

US (1)