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

Chronic Kidney Disease Clinical Trial

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT02946034
• Other study ID #: 2016P001822
• Status: Completed
• Phase: Phase 4
• Start date: February 1, 2017
• Est. completion date: September 16, 2020

Study information

• Verified date: October 2021
• Source: Massachusetts General Hospital
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 10
• Est. completion date: September 16, 2020
• Est. primary completion date: September 16, 2020
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

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

Related Conditions & MeSH terms

• Chronic Hepatitis C
• Chronic Kidney Disease
• Hepatitis
• Hepatitis A
• Hepatitis C
• Hepatitis C, Chronic
• Kidney Diseases
• Renal Insufficiency, Chronic

Intervention

Drug:
• Viekira Pak ± ribavirin
12 weeks treatment with AbbVie Viekira Pak ± ribavirin
• Mavyret
8 or 12 weeks treatment with AbbVie Mavyret

Locations

Country	Name	City	State
United States	Massachusetts General Hospital	Boston	Massachusetts

Sponsors (2)

Lead Sponsor	Collaborator
Massachusetts General Hospital	AbbVie

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	52 Weeks
Primary	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.	52 weeks
Primary	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.	52 weeks
Primary	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.	52 Weeks 52 Weeks 52 weeks
Primary	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.	52 weeks
Primary	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.	52 weeks
Secondary	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.	12 weeks
Secondary	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.	24 weeks