Direct-acting Antiviral Therapy to Prevent HCV Infection for HCV Positive Donor to HCV Negative Recipient Kidney Transplant

NCT03093740 | Withdrawn Phase 4 DMC FDA Drug

• 1 other identifier: 2017P000301
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

Brief Summary

Open label single center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.

Conditions

Renal Failure Chronic; Hepatitis C

Keywords

hemodialysis; renal failure; kidney transplant

Outcome Measures

Primary Outcomes (1)

• Undetectable HCV RNA

  Negative HCV viral load 12 weeks after last dose of treatment

  12 weeks post treatment

Study Arms (2)

HCV treatment - no viral resistance

EXPERIMENTAL

Based on the genotype and negative viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier

Drug: Zepatier

HCV treatment - viral resistance

EXPERIMENTAL

Based on the genotype and positive viral resistance testing of the donor, (determined within the first week) we will initiate a genotype specific regimen of Zepatier plus Sofosbuvir

Drug: Zepatier plus Sofosbuvir

Interventions

Zepatier DRUG

Based on negative viral resistance testing of the donor treatment will be Zepatier

HCV treatment - no viral resistance

Zepatier plus Sofosbuvir DRUG

Based on positive viral resistance testing of the donor treatment will be Zepatier with Sofosbuvir

HCV treatment - viral resistance

Eligibility Criteria

• Age: 40 Years - 70 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Donor meets MGH transplant center criteria and already listed for isolated kidney transplant
• No available living kidney donor
• Recipient has ≤ 730 days of accrued transplant waiting time
• Recipient chronic hemodialysis or peritoneal dialysis
• Recipient must agree to birth control.
• °.Weigh ≥ 50kg
• Serum ALT within normal limits
• Subject's Insurance company approves payment for DAA therapy post-kidney transplant

You may not qualify if:

• AB Blood type
• HCV genotype 1
• BMI \> 35
• Any liver disease in recipient
• Pregnant or nursing (lactating) women
• Known allergy or intolerance to tacrolimus that would require administration of cyclosporine
• Albumin \< 3g/dl or
• Platelet count \< 75 x 103/mL
• Positive crossmatch or positive donor specific antibodies
• HCV RNA positive
• Hepatitis B surface antigen positive
• Patients with primary focal segmental glomerulosclerosis (FSGS)
• Any contra-indication to kidney transplantation per our center protocol

Sponsors & Collaborators

• Massachusetts General Hospital: lead

Study Sites (1)

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hepatitis C; Renal Insufficiency

Interventions

elbasvir-grazoprevir drug combination; Sofosbuvir

Condition Hierarchy (Ancestors)

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

Intervention Hierarchy (Ancestors)

Uridine Monophosphate; Uracil Nucleotides; Pyrimidine Nucleotides; Pyrimidines; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Nucleotides; Nucleic Acids, Nucleotides, and Nucleosides; Ribonucleotides

Study Officials

• Raymond Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Hepatology, Massachusetts General Hospital

Model Details: Based on the genotype and viral resistance testing of the donor, that will be determined within the first week, we will initiate a genotype specific regimen for HCV treatment as available by prescription

Study Record Dates

• First Submitted: March 22, 2017
• First Posted: March 28, 2017
• Study Start: October 1, 2018
• Primary Completion: December 31, 2020
• Study Completion: January 31, 2021
• Last Updated: December 20, 2018

Record last verified: 2018-12

Data Sharing

• IPD Sharing: Will not share

Locations

US (1)