NCT02946034

Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C

Safety, 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

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 10 (actual)
• Sponsor: Massachusetts General Hospital · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

Summary

Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.

Detailed description

The objective of this study is to evaluate the effect of paritaprevir/ritonavir, ombitasvir, dasabuvir (referred to as Viekira Pak) ± ribavirin or Glecaprevir / Pibrentasvir (referred to as Mavyret) for adults with advanced CKD with an estimated glomerular filtration rate (eGFR) less than 45ml/min that are infected with hepatitis C virus (HCV) genotype 1 and to determine the effect of treatment on traditional and novel markers of kidney function and cardiovascular disease risk in patients with advanced CKD. During the course of this prospective, single arm treatment trial, we will measure currently accepted markers of kidney function and novel biomarkers of CKD progression to determine if they improve with eradication of HCV.

Conditions

• Chronic Kidney Disease
• Chronic Hepatitis C

Interventions

Type	Name	Description
DRUG	Viekira Pak ± ribavirin	12 weeks treatment with AbbVie Viekira Pak ± ribavirin
DRUG	Mavyret	8 or 12 weeks treatment with AbbVie Mavyret

Timeline

• Start date: 2017-02-01
• Primary completion: 2020-09-16
• Completion: 2020-09-16
• First posted: 2016-10-26
• Last updated: 2021-11-05
• Results posted: 2021-11-05

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated drug study