Kidney FailurePhase 4QUICK-CURENCT04515797

QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir

A Phase 4 study testing Glecaprevir and Pibrentasvir in people with Kidney Failure and Hepatitis C, run by Massachusetts General Hospital at 1 site in United States.

Terminated

Stopped early. The study ended before it was planned to and will not resume.

Official record

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Trial summary

This is a single center study characterizing the experience of administration of 4 weeks of pan-genotypic DAA therapy in kidney transplantation to prevent the transmission of hepatitis C virus infection from an HCV-positive donor kidney to an HCV-negative recipient. Read more about this study

Who is it for?: Ages 18 years and older
Conditions the study is for: Kidney Failure, Hepatitis C, Kidney Disease, Chronic
What is being tested?: Glecaprevir and Pibrentasvir
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 2 participants
Where: 1 siteUnited States
Study dates: 1 May 2021to 31 Aug 2023
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

Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy)
Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
Able to sign informed consent
Detectable HCV NAT test
KDPI score is less than ≤ 0.850
Traditional Donor Selection Criteria Met - acceptable for transplantation per usual evaluation

Who cannot join

Pregnant or nursing (lactating) women
HBV positivity (Ag or DNA)
Any contra-indication to kidney transplantation per MGH transplant center protocol
Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert
Confirmed HIV
Confirmed HBV positive (surface antigen or HBV DNA positive)
Any standard contra-indication to donation noted in donor (significant malignancy, unusual infection, kidney anatomical damage or significant pathology)

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

Read the detailed description

The goal of this study is to determine if the administration of glecaprevir and pibrentasvir (G/P) for 4 weeks beginning in the immediate peri-transplant period prevents establishment of HCV infection in HCV negative recipients receiving transplanted kidneys from HCV RNA positive donors.

Conditions: Kidney Failure, Hepatitis C, Kidney Disease, Chronic
Being tested: Glecaprevir and Pibrentasvir
Keywords: Kidney Transplant, Kidney Failure, HCV, Hepatitis C
Medical subject headings: Renal Insufficiency, Hepatitis C, Renal Insufficiency, Chronic

What participants receive

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

Glecaprevir and PibrentasvirDrug
Also called Direct Acting Antiviral HCV Treatment, Mavyret
4 weeks of treatment starting within 24 hrs of kidney transplant

Study groups in NCT04515797
Study group	Role	What they receive
Treatment with Direct Acting Antiviral for HCV	Experimental	4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant Receives: Drug: Glecaprevir and Pibrentasvir

What is being measured

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

Number of Participants With Undetectable Blood HCV RNA Level
Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P
Measured: 12 weeks post last dose of treatment with G/P

Secondary outcomes (4)

Adverse Events
Serious and non-serious adverse events attributed to study drug and/or HCV-viremia
Measured: 1 Year Study Period
HCV RNA Viral Load
Assessment of HCV RNA viral load at on-treatment visits, measured at both week 2 and week 4 on treatment. The viral loads measured at Week 2 and 4 are averaged together and reported in copies per mL
Measured: Measured at Week 2 and Week 4 of Treatment;
Allograft Function
Post-transplant allograft function measured by mean eGFR over study period
Measured: 1 Year Study Period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation
The rate of clinical safety outcomes: death, graft failure, acute allograft rejection, delayed graft functions, ALT elevations > 5x ULN related to study treatment with glecaprevir/Pibrentasvir
Measured: 1 Year Study Period

Timeline

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

1 May 202131 Aug 2023

First posted17 Aug 2020
Study start1 May 2021
Primary completion31 Aug 2023
Study completion31 Aug 2023

Why it stopped: Unable to meet enrollment goal prior to drug expiration

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 Kidney FailureStudies 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
Masking: None (open label)
Enrolment: 2 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT04515797
Sponsor's protocol ID: 2020P002523
Acronym: QUICK-CURE
Status last verified: Nov 2024
First submitted: 13 Aug 2020
Last updated: 3 Dec 2024
Results posted: Yes, on ClinicalTrials.gov
Data monitoring committee: No
FDA-regulated drug: Yes
FDA-regulated device: No

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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All Kidney Failure trials

Study at a glance

From the registry record, last updated by the sponsor on 3 Dec 2024. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: QUICKly Eradicate Hepatitis C in Patients Undergoing REnal Transplant With 4 Weeks of Glecaprevir/Pibrentasvir
ClinicalTrials.gov ID: NCT04515797
Acronym / sponsor ID: QUICK-CURE / 2020P002523
Conditions: Kidney Failure, Hepatitis C, Kidney Disease, Chronic
Keywords: Kidney Transplant, Kidney Failure, HCV, Hepatitis C
Phase: Phase 4
Study type: Interventional
Recruitment status: TerminatedReason stopped: Unable to meet enrollment goal prior to drug expiration
Enrolment: 2 participants (actual)
Lead sponsor: Massachusetts General HospitalUniversity, hospital or other
Study start: 1 May 2021 (actual)
Primary completion: 31 Aug 2023 (actual)
Study completion: 31 Aug 2023 (actual)
First posted: 17 Aug 2020 (actual)
Results: Posted 3 Dec 2024

Clinical summary

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

Detailed description

Study design

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

Arm	Type	Receives
Treatment with Direct Acting Antiviral for HCV	Experimental	Drug: Glecaprevir and Pibrentasvir4 week treatment period with glecaprevir and pibrentasvir (G/P) within 24 hours of transplant

Who may qualify

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

Key inclusion criteria (7 listed)

Met MGH Transplant Center criteria and already listed for kidney transplant with stage 5 CKD / ESRD (eGFR <15 ml/min/1.73m2 or on renal replacement therapy)
Must agree to birth control. Women must agree to use birth control in accordance with Mycophenolate Risk Evaluation and Mitigation Strategy and at least one barrier method
No evidence of clinically significant liver disease at the time of transplant readiness as determined by the clinical team
Able to sign informed consent
Detectable HCV NAT test

Key exclusion criteria (8 listed)

Pregnant or nursing (lactating) women
HBV positivity (Ag or DNA)
Any contra-indication to kidney transplantation per MGH transplant center protocol
Any signs or symptoms of clinically significant chronic liver disease per transplant center physician
Inability to discontinue any medication with a known drug-drug interaction as listed in the G/P package insert

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
Glecaprevir and PibrentasvirAlso: Direct Acting Antiviral HCV Treatment, Mavyret4 weeks of treatment starting within 24 hrs of kidney transplant	Drug	Treatment with Direct Acting Antiviral for HCV

Primary outcome

Number of Participants With Undetectable Blood HCV RNA Level
Time frame: 12 weeks post last dose of treatment with G/P
Negative HCV RNA by blood testing at 12 weeks after the last dose of G/P

4 secondary outcomes

Adverse Events
Time frame: 1 Year Study Period
HCV RNA Viral Load
Time frame: Measured at Week 2 and Week 4 of Treatment;
Allograft Function
Time frame: 1 Year Study Period
Rate of Death, Graft Failure, Acute Allograft Rejection, Delayed Graft Function, ALT Elevation
Time frame: 1 Year Study Period

Results and safety

Results posted to the registry on 3 Dec 2024, as reported by the sponsor. Figures are copied from the record, not re-analysed. Full results on ClinicalTrials.gov.

Participant flow

Group	Started	Completed
Treatment With Direct Acting Antiviral for HCV	2	2

Primary outcome: Number of Participants With Undetectable Blood HCV RNA Level

Time frame: 12 weeks post last dose of treatment with G/P. Count of participants. Unit: Participants

Measure	Treatment With Direct Acting Antiviral for HCV n = 2
Value	2

Population analysed: Subjects receiving at least 1 dose of G/P after receipt of donor HCV RNA positive kidney transplant

4 secondary outcomes are reported in the full results.

Adverse events

Time frame: Adverse events were captured beginning at DAA administration (Day 1) until 1-year post kidney transplant with HCV RNA-positive organ.. Other adverse events reported at 0% frequency or more

Group	Serious adverse events	Other adverse events	Deaths
Treatment With Direct Acting Antiviral for HCV	0 of 2 (0%)	0 of 2 (0%)	0 of 2

Limitations and caveats (from the sponsor): The study was closed prior to completion and prior to achieving the target of 40 participants enrolled due to the expiration of the donated investigational product (Glecaprevir / Pibrentasvir). The final study enrollment of 2 participants provides insufficient data to support analysis of all defined secondary outcomes.

Loading the posted results from ClinicalTrials.gov…

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 3 Dec 2024.
Posted resultsParticipant flow, baseline, all outcome measures and adverse events.

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RecruitingPhase 1
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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.

Nahel Elias, 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 Glecaprevir and Pibrentasvir in people with Kidney Failure and 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 7 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: stopped early, as of the sponsor's last update on 3 Dec 2024. 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 3 Dec 2024). 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?

Number of Participants With Undetectable Blood HCV RNA Level (time frame: 12 weeks post last dose of treatment with G/P). 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 NCT04515797.

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 3 Dec 2024.