Chronic Kidney DiseasePhase 4NCT02946034

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

A Phase 4 study testing Viekira Pak ± ribavirin and Mavyret in people with Chronic Kidney Disease and Chronic Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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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. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Chronic Kidney Disease, Chronic Hepatitis C
What is being tested?: Viekira Pak ± ribavirin and Mavyret
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 10 participants
Where: 1 siteUnited States
Study dates: 1 Feb 2017to 16 Sep 2020
Phase: Phase 4
Are there results?: Yes, posted in the registrySummary in the doctors' view

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 years and older
All sexes
No healthy volunteers
Adult, Older adult

Who may be able to join

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

Who cannot join

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

Trial locations and contacts

1 site in 1 country.

United States1 site

Massachusetts General Hospital
Boston, Massachusetts, 02114

Other trials in United States

About this study

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

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

Read the 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.

Conditions: Chronic Kidney Disease, Chronic Hepatitis C
Being tested: Viekira Pak ± ribavirin, Mavyret
Keywords: CKD, HCV
Medical subject headings: Renal Insufficiency, Chronic, Hepatitis C, Chronic

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Viekira Pak ± ribavirinDrug
Also called AbbVie 3D regimen
12 weeks treatment with AbbVie Viekira Pak ± ribavirin
MavyretDrug
8 or 12 weeks treatment with AbbVie Mavyret

Study groups in NCT02946034
Study group	Role	What they receive
Viekira Pak ± ribavirin or Mavyret	Experimental	12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret Receives: Drug: Viekira Pak ± ribavirin; Drug: Mavyret

What is being measured

The primary outcome is the main question the study is designed to answer.

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.
Measured: 52 Weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 Weeks 52 Weeks 52 weeks
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.
Measured: 52 weeks
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.
Measured: 52 weeks

Secondary outcomes (2)

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.
Measured: 12 weeks
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.
Measured: 24 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

1 Feb 201716 Sep 2020

First posted26 Oct 2016 (estimated)
Study start1 Feb 2017
Primary completion16 Sep 2020
Study completion16 Sep 2020

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Posted resultsParticipant flow, outcome measures and adverse events reported by the sponsor.
Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
More trials run by Massachusetts General HospitalThe sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase 4
Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
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)
Enrolment: 10 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT02946034
Sponsor's protocol ID: 2016P001822
Status last verified: Oct 2021
First submitted: 21 Oct 2016
Last updated: 5 Nov 2021
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: Yes
FDA-regulated drug: Yes
FDA-regulated device: No
Individual data sharing: Yes: Results data will be shared with the study sponsor and publication of data is anticipated.

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Study at a glance

From the registry record, last updated by the sponsor on 5 Nov 2021. Recruitment status is as the sponsor reported it: confirm with the study team.

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
ClinicalTrials.gov ID: NCT02946034
Acronym / sponsor ID: 2016P001822
Conditions: Chronic Kidney Disease, Chronic Hepatitis C
Keywords: CKD, HCV
Phase: Phase 4
Study type: Interventional
Recruitment status: Completed
Enrolment: 10 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Collaborators: AbbVie
Study start: 1 Feb 2017 (actual)
Primary completion: 16 Sep 2020 (actual)
Study completion: 16 Sep 2020 (actual)
First posted: 26 Oct 2016 (estimated)
Results: Posted 5 Nov 2021

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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

Study design

Primary purpose: Treatment
Allocation: Not applicable
Intervention model: Single group
Masking: None (open label)
Number of arms: 1
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.

Arm	Type	Receives
Viekira Pak ± ribavirin or Mavyret	Experimental	Drug: Viekira Pak ± ribavirin, Drug: Mavyret12 week therapy with Viekira Pak ± ribavirin 8 or 12 week therapy with Mavyret

Who may qualify

Ages: 18 years and older
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Key inclusion criteria (3 listed)

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

Key exclusion criteria (8 listed)

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

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Viekira Pak ± ribavirinAlso: AbbVie 3D regimen12 weeks treatment with AbbVie Viekira Pak ± ribavirin	Drug	Viekira Pak ± ribavirin or Mavyret
Mavyret8 or 12 weeks treatment with AbbVie Mavyret	Drug	Viekira Pak ± ribavirin or Mavyret

Primary outcome

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.
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.
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.
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.
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.
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.

2 secondary outcomes

Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability)
Time frame: 12 weeks
Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment)
Time frame: 24 weeks

Results and safety

Results posted to the registry on 5 Nov 2021, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Viekira Pak ± Ribavirin or Mavyret	10	10

Primary outcome: Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

Time frame: 52 Weeks. Mean (Standard Deviation). Unit: ng/g

Measure	Viekira Pak ± Ribavirin or Mavyret n = 8
Value	-0.05 (0.61)

Population analysed: 2 patients did not have urine TNF-alpha tested at these timepoints.

Primary outcome: Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment

Time frame: 52 weeks. Mean (Standard Deviation). Unit: ng/g

Measure	Viekira Pak ± Ribavirin or Mavyret n = 8
Value	5.73 (12.18)

Population analysed: 2 patients did not have urine IL-6 tested at these timepoints.

Primary outcome: Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment

Time frame: 52 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Viekira Pak ± Ribavirin or Mavyret n = 8
Value	6.67 (42.87)

Population analysed: 2 patients did not have plasma TNF-alpha tested at these timepoints.

Primary outcome: Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment

Time frame: 52 Weeks 52 Weeks 52 weeks. Mean (Standard Deviation). Unit: pg/mL

Measure	Viekira Pak ± Ribavirin or Mavyret n = 8
Value	-394.57 (657.80)

Population analysed: 2 patients did not have plasma IP-10 tested at these timepoints.

2 secondary outcomes are reported in the full results.

Adverse events

Time frame: Each patient was followed for one year after initiation of treatment.. Other adverse events reported at 5% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Viekira Pak ± Ribavirin or Mavyret	5 of 10 (50%)	8 of 10 (80%)	0 of 10

Limitations and caveats (from the sponsor): Our study has several limitations. Our pilot trial was limited by the small number of patients enrolled. Additionally, two subjects were lost to follow-up, decreasing the power of our analysis comparing pre- and post-treatment kidney function and biomarkers. Thus, the analysis presented is descriptive in nature. The analysis is limited by the absence of a control group.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 5 Nov 2021.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.
Individual participant dataSharing planned: Yes. Results data will be shared with the study sponsor and publication of data is anticipated.

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Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Raymond T Chung, MD principal investigator

Massachusetts General Hospital

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

A Phase 4 study testing Viekira Pak ± ribavirin and Mavyret in people with Chronic Kidney Disease and Chronic Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 3 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 5 Nov 2021. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

Yes. Results are posted in the registry (first posted 5 Nov 2021). A summary is in the For doctors view, and the full results are on ClinicalTrials.gov.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment (time frame: 52 Weeks). The study lists 6 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT02946034.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 5 Nov 2021.