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Completed

NCT Number: NCT02946034

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

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

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Key information

Conditions

Chronic Kidney Disease Blood-Borne Infections Chronic Disease Chronic Hepatitis C Communicable Diseases Digestive System Diseases Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Flaviviridae Infections Hepatitis Hepatitis C Hepatitis C, Chronic Hepatitis, Chronic Hepatitis, Viral, Human Infections Kidney Diseases Liver Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms RNA Virus Infections Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases Virus Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 4

Primary location

Massachusetts General Hospital

Boston, Massachusetts, 02114, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Viekira Pak ± ribavirin

Drug

12 weeks treatment with AbbVie Viekira Pak ± ribavirin

Other names: AbbVie 3D regimen

Mavyret

Drug

8 or 12 weeks treatment with AbbVie Mavyret

Primary outcomes

  1. Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

    Time frame: 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.

  2. Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment

    Time frame: 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.

  3. Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

    Time frame: 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.

  4. Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment

    Time frame: 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.

  5. Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment

    Time frame: 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.

  6. Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment

    Time frame: 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 outcomes

  1. Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)

    Time frame: 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.

  2. Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)

    Time frame: 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.

Sponsors and collaborators

Lead sponsor

Massachusetts General Hospital

Other

Collaborators

  • AbbVie

Registry information

Official study 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

Important dates

Study start
2017
Primary completion
2020
Study completion
2020
First posted
Oct 26, 2016
Registry last updated
Nov 5, 2021

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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