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

Phase 4

Completed

• Conditions: Chronic Kidney Disease; Chronic Hepatitis C
• Interventions: Drug: Viekira Pak ± ribavirin; Drug: Mavyret

• Registration Number: NCT02946034
• Lead Sponsor: Massachusetts General Hospital

Brief 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.

Basic Information
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Recruitment & Eligibility
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Study & Design
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Trial Locations

Study Timeline

• Study First Submitted: 2016-10-21
• Study First Submitted QC: 2016-10-25
• Study First Posted: 2016-10-26
• Study Start: 2017-02-01
• Primary Completion: 2020-09-16
• Study Completion: 2020-09-16
• Results First Submitted: 2021-09-08
• Status Verified: 2021-10
• Results First Submitted QC: 2021-10-05
• Last Update Submitted: 2021-10-05
• Results First Posted: 2021-11-05
• Last Update Posted: 2021-11-05

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 10

Inclusion Criteria

1. Male or female ≥ 18 year of age
2. HCV genotype 1 ≥ 1000 IU/mL
3. 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation

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Exclusion Criteria

1. Pregnant or lactating females
2. Uncontrolled depression or psychiatric disease
3. History or presence of any form of cancer within 3 years of enrollment
4. Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
5. Uncontrolled cardiovascular or pulmonary disease
6. Experiencing symptoms attributed to uremia
7. Anticipated need to begin renal replacement therapy in the next 6 months
8. History of kidney transplant

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Viekira Pak ± ribavirin or Mavyret	Viekira Pak ± ribavirin	12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret
Viekira Pak ± ribavirin or Mavyret	Mavyret	12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret

Primary Outcome Measures

Name	Time	Method
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	52 Weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment	52 weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment	52 weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment	52 Weeks 52 Weeks 52 weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment	52 weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.
Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment	52 weeks	Measure of novel biomarkers of incident and progressive CKD and liver disease to determine if eradication of HCV infection changes the measures of chronic inflammation associated with progressive end-organ disease.; To calculate the average change, the difference between baseline values and the average of 12-weeks post treatment and 40-weeks post treatment were found for each patient. These differences were then averaged, as shown below.

Secondary Outcome Measures

Name	Time	Method
Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)	12 weeks	Safety and tolerability of Viekira Pak treatment in CKD patients will be assessed by number of patients who suffered adverse events (serious or otherwise) deemed to be related to study drug.
Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)	24 weeks	Efficacy will be determined by negative HCV RNA viral load measured during the 12 week treatment period as well as 12 weeks after the last dose.

Trial Locations

Locations (1)

Massachusetts General Hospital; 🇺🇸 Boston, Massachusetts, United States