Multi-center Study to Transplant Hepatitis-C Infected Kidneys

NCT03781726 | Completed Phase 4 Results DMC FDA Drug

• 1 other identifier: 2018P003140
• Study Type: interventional
• Target: 30
• Locations: 1 country
• Sites: 7

Brief Summary

Open label multi 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)

• Number of Participants With Undetectable HCV

  HCV RNA \< LLOQ 12 weeks after the last actual dose of G/P

  12 weeks post treatment

Secondary Outcomes (2)

• Percentage of Subjects With On-treatment Virologic Failure

  During 8 week treatment course

• Percentage of Subjects With Post-treatment Virologic Relapse

  During 12 week post treatment follow-up

Study Arms (1)

Treatment with glecaprevir/pibrentasvir Fixed Dose Combination

EXPERIMENTAL

8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir

Drug: glecaprevir/pibrentasvir treatment

Interventions

glecaprevir/pibrentasvir treatment DRUG

combination treatment with glecaprevir and pibrentasvir fixed dose tablet.

Also known as: Mavyret treatment

Treatment with glecaprevir/pibrentasvir Fixed Dose Combination

Eligibility Criteria

• Age: 21 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Estimated glomerular filtration rate(eGFR) \< 15 ml/min/1.73 m2
• Listed for an isolated kidney transplantation
• Able to understand and adhere to the study visit schedule and all other protocol requirements, and must voluntarily sign and date an informed consent
• No available medically acceptable, compatible living kidney donor
• Subject must agree to use an effective method of birth control per protocol specifications

You may not qualify if:

• History of severe, life-threatening or other significant sensitivity to immunosuppressants utilized in kidney transplant
• Female who is pregnant, breastfeeding, or is planning to become pregnant during the course of the study
• History of HIV
• HCV RNA positive
• HBV surface Ag-positive or detectable HBV DNA
• Primary focal segmental glomerulosclerosis (FSGS) or disease process with increased risk of causing early graft failure as assessed by the transplant nephrologist and/or investigator team
• Presence of clinically significant liver disease
• Transplant candidate requiring antibody desensitization protocol for transplantation
• Most recent calculated panel reactive antibody (cPRA) \>80%.
• Prior recipient of a non-renal solid organ transplant
• Deceased donor organ with kidney donor profile index (KDPI) ≤0.85
• HCV RNA-positive
• Known prior HCV treatment with direct acting antiviral medication
• HIV RNA-positive
• HBV Surface antigen-positive or HBV DNA-positive

Sponsors & Collaborators

• Raymond Chung: lead
• AbbVie: collaborator
• University of Pennsylvania: collaborator
• Johns Hopkins University: collaborator
• University of Cincinnati: collaborator
• Weill Medical College of Cornell University: collaborator
• University of Michigan: collaborator
• Northwestern University: collaborator

Study Sites (7)

Northwestern Medicine

Chicago, Illinois, 60611, United States

Location

John Hopkins

Baltimore, Maryland, 21287, United States

Location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

Location

University of Michigan

Ann Arbor, Michigan, 48109, United States

Location

Weill Cornell Medical Center

New York, New York, 10065, United States

Location

University of Cincinnati Medical Center

Cincinnati, Ohio, 45219, United States

Location

University of Pennsylvania

Philadelphia, Pennsylvania, 19104, United States

Location

Related Publications (1)

• Sise ME, Goldberg DS, Schaubel DE, Fontana RJ, Kort JJ, Alloway RR, Durand CM, Blumberg EA, Woodle ES, Sherman KE, Brown RS Jr, Friedewald JJ, Desai NM, Sultan ST, Levitsky J, Lee MD, Strohbehn IA, Landis JR, Fernando M, Gustafson JL, Chung RT, Reese PP. One-Year Outcomes of the Multi-Center StudY to Transplant Hepatitis C-InfeCted kidneys (MYTHIC) Trial. Kidney Int Rep. 2021 Dec 1;7(2):241-250. doi: 10.1016/j.ekir.2021.11.022. eCollection 2022 Feb.

  PMID: 35155863 DERIVED

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hepatitis C; Renal Insufficiency

Interventions

glecaprevir

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

Results Point of Contact

• Title: Peter Reese
• Organization: University of Pennsylvania

Peter.Reese@pennmedicine.upenn.edu

215-573-8070

Study Officials

• Raymond T Chung, MD

  Massachusetts General Hospital

  PRINCIPAL INVESTIGATOR

Publication Agreements

• PI is Sponsor Employee: No
• Restrictive Agreement: No

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: December 18, 2018
• First Posted: December 20, 2018
• Study Start: April 10, 2019
• Primary Completion: March 20, 2020
• Study Completion: December 31, 2021
• Last Updated: January 26, 2022
• Results First Posted: May 11, 2021

Record last verified: 2022-01

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR
• Time Frame: Real time
• Access Criteria: researchers accessing IPD must be an approved site within the consortium.

Locations

US (7)