Completed

Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir or Glecaprevir/Pibrentasvir for Advanced CKD Patients with HCV Genotype 1: Impact on Kidney Function and Cardiovascular Disease Risk

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Study Aim

This study aims to evaluate the impact of Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir or Glecaprevir/Pibrentasvir treatment on kidney function and cardiovascular disease risk in advanced CKD patients with HCV Genotype 1, by measuring changes in specific biomarkers from baseline to post-treatment.

What is being tested

Viekira Pak ± ribavirin

+ Mavyret

Drug
Who is being recruted

Blood-Borne Infections+22

+ Urogenital Diseases

+ Chronic Disease

Over 18 Years
+11 Eligibility Criteria
See all eligibility criteria
How is the trial designed

Treatment Study

Phase 4
Interventional
Study Start: February 2017
See protocol details

Summary

Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Study start date: February 1, 2017

Actual date on which the first participant was enrolled.

This study focuses on adults with advanced chronic kidney disease (CKD) who have an estimated glomerular filtration rate (eGFR) less than 45ml/min and are infected with hepatitis C virus (HCV) genotype 1. The main goal is to evaluate the safety and effectiveness of two treatment regimens: Viekira Pak (paritaprevir/ritonavir, ombitasvir, dasabuvir) ± ribavirin or Mavyret (Glecaprevir / Pibrentasvir). The study also aims to understand how these treatments affect traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. The potential outcomes of this study could lead to improved care for patients with HCV and advanced CKD, addressing a significant unmet need in this population. During this study, participants will receive either the Viekira Pak or Mavyret regimen. The study will measure accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with the eradication of HCV. The primary outcomes include measuring the average change in various plasma and urine biomarkers from baseline to post-treatment. These biomarkers include Interferon Gamma-induced Protein 10 (IP-10), Interferon (IFN)-Gamma, Interleukin (IL)-6, Tumor Necrosis Factor (TNF)-Alpha, among others. The changes in these biomarkers will be calculated by finding the difference between baseline values and the average of 12-weeks post-treatment and 40-weeks post-treatment for each patient.

Official TitleSafety, Efficacy, and Changes in Traditional and Novel Biomarkers of Kidney Function in Patients With Hepatitis C and Advanced Chronic Kidney Disease Treated With Abbvie Viekira Pak or Mavyret Regimen
NCT02946034
Principal SponsorMassachusetts General Hospital
Last updated: January 28, 2026
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

10 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

Over 18 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Blood-Borne InfectionsUrogenital DiseasesChronic DiseaseCommunicable DiseasesDigestive System DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsHepatitisHepatitis, ChronicHepatitis, Viral, HumanHepatitis CInfectionsKidney DiseasesLiver DiseasesPathologic ProcessesRNA Virus InfectionsPathological Conditions, Signs and SymptomsUrologic DiseasesVirus DiseasesFlaviviridae InfectionsHepatitis C, ChronicDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital Diseases

Criteria

3 inclusion criteria required to participate
Male or female ≥ 18 year of age

HCV genotype 1 ≥ 1000 IU/mL

6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

8 exclusion criteria prevent from participating
Pregnant or lactating females

Uncontrolled depression or psychiatric disease

History or presence of any form of cancer within 3 years of enrollment

Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.

Show More Criteria

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

One single intervention group is designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Experimental
12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

Suspended

Massachusetts General Hospital

Boston, United StatesOpen Massachusetts General Hospital in Google Maps
CompletedOne Study Center