Back to resultsViekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Primary Purpose
Chronic Kidney Disease, Chronic Hepatitis C
Status
Completed
Phase
Phase 4
Locations
United States
Study Type
Interventional
Intervention
Viekira Pak ± ribavirin
Mavyret
Sponsored by
About this trial
This is an interventional treatment trial for Chronic Kidney Disease focused on measuring CKD, HCV
Eligibility Criteria
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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.
- Uncontrolled cardiovascular or pulmonary disease
- Experiencing symptoms attributed to uremia
- Anticipated need to begin renal replacement therapy in the next 6 months
- History of kidney transplant
Sites / Locations
- Massachusetts General Hospital
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Viekira Pak ± ribavirin or Mavyret
Arm Description
12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret
Outcomes
Primary Outcome Measures
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
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
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
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
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
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
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
Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)
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)
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.
Full Information
NCT ID
NCT02946034
First Posted
October 21, 2016
Last Updated
October 5, 2021
Sponsor
Massachusetts General Hospital
Collaborators
AbbVie
1. Study Identification
Unique Protocol Identification Number
NCT02946034
Brief Title
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Official Title
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
Study Type
Interventional
2. Study Status
Record Verification Date
October 2021
Overall Recruitment Status
Completed
Study Start Date
February 1, 2017 (Actual)
Primary Completion Date
September 16, 2020 (Actual)
Study Completion Date
September 16, 2020 (Actual)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Principal Investigator
Name of the Sponsor
Massachusetts General Hospital
Collaborators
AbbVie
4. Oversight
Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
Yes
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Chronic Kidney Disease, Chronic Hepatitis C
Keywords
CKD, HCV
7. Study Design
Primary Purpose
Treatment
Study Phase
Phase 4
Interventional Study Model
Single Group Assignment
Model Description
This a single-arm study. Initially, Viekira Pak was available through Abbvie. However, once Mavyret became available, it supplanted Viekira Pak as the study medication.
Masking
None (Open Label)
Allocation
N/A
Enrollment
10 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Viekira Pak ± ribavirin or Mavyret
Arm Type
Experimental
Arm Description
12 week therapy with Viekira Pak ± ribavirin
8 or 12 week therapy with Mavyret
Intervention Type
Drug
Intervention Name(s)
Viekira Pak ± ribavirin
Other Intervention Name(s)
AbbVie 3D regimen
Intervention Description
12 weeks treatment with AbbVie Viekira Pak ± ribavirin
Intervention Type
Drug
Intervention Name(s)
Mavyret
Intervention Description
8 or 12 weeks treatment with AbbVie Mavyret
Primary Outcome Measure Information:
Title
Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
Description
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.
Time Frame
52 Weeks
Title
Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment
Description
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.
Time Frame
52 weeks
Title
Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
Description
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.
Time Frame
52 weeks
Title
Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment
Description
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.
Time Frame
52 Weeks 52 Weeks 52 weeks
Title
Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment
Description
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.
Time Frame
52 weeks
Title
Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment
Description
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.
Time Frame
52 weeks
Secondary Outcome Measure Information:
Title
Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)
Description
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.
Time Frame
12 weeks
Title
Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)
Description
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.
Time Frame
24 weeks
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
Inclusion Criteria:
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
Exclusion Criteria:
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.
Uncontrolled cardiovascular or pulmonary disease
Experiencing symptoms attributed to uremia
Anticipated need to begin renal replacement therapy in the next 6 months
History of kidney transplant
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Raymond T Chung, MD
Organizational Affiliation
Massachusetts General Hospital
Official's Role
Principal Investigator
Facility Information:
Facility Name
Massachusetts General Hospital
City
Boston
State/Province
Massachusetts
ZIP/Postal Code
02114
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Yes
IPD Sharing Plan Description
Results data will be shared with the study sponsor and publication of data is anticipated.
Learn more about this trial
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
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