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Antiviral

Glecaprevir/Pibrentasvir for Hepatitis C in Kidney Transplant Recipients

Q: Is this research endeavor recruiting individuals aged fifty or above?

To be qualified for this medical experiment, patients must fit in the 18-99 age range. Participants younger than legal adulthood are eligible to take part in 11 trials while above retirement individuals can join up with 109 different studies.

Q: Could you please discuss any other investigations regarding Glecaprevir/pibrentasvir?

At present, 11 medical trials concerning Glecaprevir/pibrentasvir are in progress. Out of those studies, 2 have entered Phase 3. This treatment is being tested across 115 locations worldwide; the majority of these sites are located in Baltimore, <a href="https://www.withpower.com/clinical-trials/maryland">Maryland</a>.

Q: Is there a way for me to be included in this investigation?

In order to qualify for this trial, potential participants must have end-stage renal disease and fall between 18 and 99 years old. This clinical study is looking for approximately 20 patients.

Q: What is the current enrollment count for this medical experiment?

Unfortunately, this trial is no longer taking on patients. It was posted in March of 2022 and underwent its last revision on August 5th that same year. For those seeking similar studies, there are 107 trials involving ESRD as well 11 involving Glecaprevir/pibrentasvir which are open for recruitment at the present time.

Q: What common ailments does Glecaprevir/pibrentasvir help to treat?

Glecaprevir/pibrentasvir is a versatile medication, often used to treat those who've had prior experience with ns5a inhibitor. Additionally, it can assist patients suffering from <a href="https://www.withpower.com/clinical-trials/hepatitis-c">hepatitis c</a>, chronic hepatitis c genotype 5, and chronic hepatitis c genotype 2.

Q: Are there any open positions in this experiment for individuals to participate?

As per clinicaltrials.gov, this medical study is not accepting any further participants at the moment; it was posted on March 20th 2022 and its most recent update was on August 5th 2022. Nonetheless, 118 other trials are currently open for recruitment.

Phase < 1

Waitlist Available

Led By Bonnie Lonze, MD, PhD

Research Sponsored by NYU Langone Health

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

Receive an organ offer for a kidney from a deceased donor that: Is HCV NAT positive

Meets all standard criteria for organ acceptability at NYU Langone Transplant Institute

Timeline

Screening 3 weeks

Treatment Varies

Follow Up visit 2 (day 1) , visit 3 (day 3) , visit 4 (day 7), visit 5 (day 13), visit 16 (day 365)

Awards & highlights

Study Summary

This trial will test if a 2-week course of glecaprevir/pibrentasvir can treat HCV in kidney transplant recipients before transplantation.

Who is the study for?

This trial is for adults listed for kidney transplantation at NYU Langone Health, willing to accept HCV positive donor organs. Participants must agree to use contraception and attend post-transplant visits for a year. Excluded are pregnant or nursing women, those with certain liver diseases, dual organ recipients, HIV or HBV positives, and anyone allergic to the study drugs.Check my eligibility

What is being tested?

The study tests a preemptive 2-week treatment of glecaprevir/pibrentasvir (Mavyret) starting just before kidney transplant in patients receiving an HCV positive kidney to treat hepatitis C virus.See study design

What are the potential side effects?

Potential side effects of glecaprevir/pibrentasvir may include headache, fatigue, nausea and sometimes more serious liver problems. Side effects vary from person to person.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

Select...

I am receiving a kidney from a donor who had hepatitis C.

Select...

My organs meet all the requirements for a transplant at NYU Langone.

Select...

I am on the kidney transplant list at NYU Langone Health and open to receiving a kidney from an HCV positive donor.

Select...

I am 18 years old or older.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ visit 2 (day 1) , visit 3 (day 3) , visit 4 (day 7), visit 5 (day 13), visit 16 (day 365)

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~visit 2 (day 1) , visit 3 (day 3) , visit 4 (day 7), visit 5 (day 13), visit 16 (day 365)

This trial's timeline: 3 weeks for screening, Varies for treatment, and visit 2 (day 1) , visit 3 (day 3) , visit 4 (day 7), visit 5 (day 13), visit 16 (day 365) for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Change in the Percentage of Incidence of sustained clearance of HCV (cure) 12 weeks after treatment of viremia

Secondary outcome measures

Change in the Allograft function

Percentage of Incidence HCV viremia post-transplant and after 2 weeks of treatment

Percentage of Incidence and grade of biopsy-proven rejection

+5 more

Side effects data

From 2023 Phase 4 trial • 10 Patients • NCT04575896

20%

hyperkalemia

10%

urinary tract infection

10%

dialysis access malfunction

10%

sepsis

10%

acute kidney injury

10%

anemia

10%

hypotension (orthostatic)

10%

creatinine increased

10%

flash pulmonary edema

10%

right iliac hematoma

10%

fever

10%

atrial fibrillation

100%

80%

60%

40%

20%

Study treatment Arm

Deceased Donor HCV RNA PCR+

Trial Design

1Treatment groups

Experimental Treatment

Group I: Study groupExperimental Treatment1 Intervention

All study subjects will receive glecaprevir/pibrentasvir (Mavyret®) 300/120 mg orally x 14 days, starting on POD 0 prior to transplantation of the HCV positive kidney. If HCV RNA is detectable after 2 weeks of therapy, Mavyret® will be continued to complete a full course of 8 weeks per standard of care. Safety monitoring and frequent surveillance for HCV viremia will occur for all subjects throughout the duration of the study. The kidney transplantation procedure and routine post-transplant management will be performed per standard of care.

Treatment

First Studied

Drug Approval Stage

How many patients have taken this drug

Glecaprevir/pibrentasvir

2020

Completed Phase 4

~300

0 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

NYU Langone HealthLead Sponsor

1,367 Previous Clinical Trials

839,741 Total Patients Enrolled

Bonnie Lonze, MD, PhDPrincipal InvestigatorNYU Langone Health

Media Library

Glecaprevir/pibrentasvir (Antiviral) Clinical Trial Eligibility Overview. Trial Name: NCT04682509 — Phase < 1

Renal Disease Research Study Groups: Study group

Renal Disease Clinical Trial 2023: Glecaprevir/pibrentasvir Highlights & Side Effects. Trial Name: NCT04682509 — Phase < 1

Glecaprevir/pibrentasvir (Antiviral) 2023 Treatment Timeline for Medical Study. Trial Name: NCT04682509 — Phase < 1

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Is this research endeavor recruiting individuals aged fifty or above?

"To be qualified for this medical experiment, patients must fit in the 18-99 age range. Participants younger than legal adulthood are eligible to take part in 11 trials while above retirement individuals can join up with 109 different studies."

Answered by AI

Could you please discuss any other investigations regarding Glecaprevir/pibrentasvir?

"At present, 11 medical trials concerning Glecaprevir/pibrentasvir are in progress. Out of those studies, 2 have entered Phase 3. This treatment is being tested across 115 locations worldwide; the majority of these sites are located in Baltimore, Maryland."

Answered by AI

Is there a way for me to be included in this investigation?

"In order to qualify for this trial, potential participants must have end-stage renal disease and fall between 18 and 99 years old. This clinical study is looking for approximately 20 patients."

Answered by AI

What is the current enrollment count for this medical experiment?

"Unfortunately, this trial is no longer taking on patients. It was posted in March of 2022 and underwent its last revision on August 5th that same year. For those seeking similar studies, there are 107 trials involving ESRD as well 11 involving Glecaprevir/pibrentasvir which are open for recruitment at the present time."

Answered by AI

What common ailments does Glecaprevir/pibrentasvir help to treat?

"Glecaprevir/pibrentasvir is a versatile medication, often used to treat those who've had prior experience with ns5a inhibitor. Additionally, it can assist patients suffering from hepatitis c, chronic hepatitis c genotype 5, and chronic hepatitis c genotype 2."

Answered by AI

Are there any open positions in this experiment for individuals to participate?

"As per clinicaltrials.gov, this medical study is not accepting any further participants at the moment; it was posted on March 20th 2022 and its most recent update was on August 5th 2022. Nonetheless, 118 other trials are currently open for recruitment."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation

2022. "A Single-center Pilot Study Evaluating a Preemptive Short Course of Glecaprevir/Pibrentasvir in Hepatitis C Positive to Negative Kidney Transplantation". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT04682509.

All > Autoimmune Hepatitis > Kidney Transplant