Paritaprevir/Ritonavir, Ombitasvir, Dasabuvir or Glecaprevir/Pibrentasvir for Advanced CKD Patients with HCV Genotype 1: Impact on Kidney Function and Cardiovascular Disease Risk
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.
Viekira Pak ± ribavirin
+ Mavyret
Blood-Borne Infections+22
+ Urogenital Diseases
+ Chronic Disease
Treatment Study
Summary
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.
Protocol
This section provides details of the study plan, including how the study is designed and what the study is measuring.10 patients to be enrolled
Total number of participants that the clinical trial aims to recruit.Treatment Study
Eligibility
Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.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
Criteria
Study Plan
Find out more about all the medication administered in this study, their detailed description and what they involve.One single intervention group is designated in this study
This study does not include a placebo group
Treatment Groups
Group I
ExperimentalStudy 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
Massachusetts General Hospital
Boston, United StatesOpen Massachusetts General Hospital in Google Maps