Clinical trial NCT02946034: 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
Overall status: COMPLETED
Phase: PHASE4
Conditions: Chronic Kidney Disease
Chronic Hepatitis C
Keywords: CKD
HCV
Lead sponsor: Massachusetts General Hospital
Sponsor class: OTHER
Collaborators: name: AbbVie
First posted: 2016-10-26
Enrollment: 10
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Intervention 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.
Primary purpose: TREATMENT

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.

Eligibility criteria: 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

Primary outcomes:
measure: Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
timeFrame: 52 Weeks
measure: Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment
timeFrame: 52 weeks
measure: Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment
timeFrame: 52 weeks
measure: Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment
timeFrame: 52 Weeks 52 Weeks 52 weeks
measure: Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment
timeFrame: 52 weeks
measure: Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment
timeFrame: 52 weeks
Secondary outcomes:
measure: Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)
timeFrame: 12 weeks
measure: Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)
timeFrame: 24 weeks
Other outcomes:
Locations:
city: Boston
country: United States
facility: Massachusetts General Hospital
state: Massachusetts
Study officials:
affiliation: Massachusetts General Hospital
name: Raymond T Chung, MD
role: PRINCIPAL_INVESTIGATOR
References: