A Phase 4 interventional study of 300mg glecaprevir/pibrentasivir 120mg in End Stage Renal Disease and Hepatitis C, sponsored by Johns Hopkins University. Completed at 1 site in United States. Open to participants aged 40 Years and older. Per ClinicalTrials.gov, last updated 2021-10-19.
Sponsored by Johns Hopkins University · Phase 4, Interventional, and Treatment
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant.
In this study, individuals without hepatitis C infection who are on the kidney transplant waitlist will receive a kidney from a deceased donor with hepatitis C infection and will be treated for hepatitis C at the same time. Treatment will include glecaprevir 300 mg / pibrentasvir 120 mg (G-P) administered on-call to the operating room for the renal transplant procedure and continued for 4 weeks post-renal transplant. The participant will continue to be tested for Hepatitis C for 12 weeks post-treatment.
The primary hypothesis is that prophylactic treatment with glecaprevir/pibrentasvir before and after transplant will prevent the establishment of HCV infection in the recipients of kidneys from HCV-infected deceased donors. Based on the success of preliminary studies, the objective of the study is to evaluate the safety and efficacy of 4 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.
2,709 studies on the registry are indexed under Hepatitis A; 142 are open to participants now.
This study's enrollment of 11 is below the median of 100 across 1,886 interventional studies indexed under Hepatitis A.
Browse Hepatitis A studies →Johns Hopkins University is the lead sponsor of 1,783 studies on the registry; 313 are open to participants now.
Of its 203 completed or terminated interventional studies of FDA-regulated products, 140 (69%) have results posted.
Counted across the registry records on this site, refreshed daily.
Recipient Inclusion Criteria
Recipient Exclusion Criteria
Participants who receive a kidney from HCV RNA PCR + deceased donor will receive 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks
Drug: 300mg glecaprevir/pibrentasivir 120mg
300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Also known as: Mavyret
Viral Response at Week 12
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 12
Time frame: 12 weeks after completing therapy
Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P
Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.
Time frame: 4 weeks after transplant
Viral Response at 1 Week
This is the number of participants with undetectable hepatitis C RNA in the blood at 1 week after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 1
Time frame: 1 week after completing therapy
Viral Response at 2 Weeks
This is the number of participants with undetectable hepatitis C RNA in the blood at 2 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 2
Time frame: 2 weeks after completing therapy
Viral Response at 4 Weeks
This is the number of participants with undetectable hepatitis C RNA in the blood at 4 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 4
Time frame: 4 weeks after completing therapy
Viral Response at 8 Weeks
This is the number of participants with undetectable hepatitis C RNA in the blood at 8 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 8
Time frame: 8 weeks after completing therapy
Antibody Development
Number of kidney transplant recipients that become reactive for HCV antibody
Time frame: week 12 after discontinuation of therapy
T-cell Response at Baseline
Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides.
Time frame: Baseline prior to induction therapy
T-cell Response at 12 Weeks
Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides.
Time frame: Week12 after discontinuation of therapy
Kidney Function at 6 Months
Serum creatinine mg/dL at 6 months following transplantation
Time frame: 6 months following transplant
Kidney Function at 12 Months
Serum creatinine mg/dL at 12 months following transplantation
Time frame: 12 months following transplant
| Milestone | Deceased Donor HCV RNA PCR+ |
|---|---|
| Started | 10 |
| Completed | 10 |
| Not completed | 0 |
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 12
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Viral Response at Week 12 | 10 |
Proportion of participants with grade 3 or higher treatment-related adverse events (AE) as assessed by US Department of Health and Human Services Common Terminology of AEs version 4. An AE is an unfavorable and unintended sign (including an abnormal laboratory finding), symptom, or disease temporally associated with the use of a medical treatment or procedure that may or may not be considered related to the medical treatment or procedure. Grade refers to the severity of the AE. The CTCAE displays Grades 1 through 5. Grade 3 Severe or medically significant but not life-threatening; hospitalization or prolongation of hospitalization indicated; disabling; Grade 4 Life-threatening consequences; urgent intervention indicated. Grade 5 Death related to AE. The investigator will determine if the AE is related to the treatment.
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P | 0 |
This is the number of participants with undetectable hepatitis C RNA in the blood at 1 week after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 1
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Viral Response at 1 Week | 8 |
This is the number of participants with undetectable hepatitis C RNA in the blood at 2 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 2
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Viral Response at 2 Weeks | 10 |
This is the number of participants with undetectable hepatitis C RNA in the blood at 4 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 4
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Viral Response at 4 Weeks | 10 |
This is the number of participants with undetectable hepatitis C RNA in the blood at 8 weeks after stopping treatment. Proportion of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ) at week 8
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Viral Response at 8 Weeks | 10 |
Number of kidney transplant recipients that become reactive for HCV antibody
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| Antibody Development | 9 |
Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides.
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| No T-cell response at baseline | 6 |
| T-cell response to 1 peptide at baseline | 1 |
| T-cell response to 2 peptides at baseline | 2 |
| T-cell response to 3 peptides at baseline | 1 |
Measurement of t-cell response to HCV peptides, a marker of acute hepatitis C infection. This categorizes participants into no T-cell response, T-cell response to 1 peptide, T-cell response to 2 peptides and T-cell response to 3 peptides.
| Participants | Deceased Donor HCV RNA PCR+ |
|---|---|
| No T-cell response at 12 weeks | 5 |
| T-cell response to 1 peptide at 12 weeks | 3 |
| T-cell response to 2 peptides at 12 weeks | 1 |
| T-cell response to 3 peptides at 12 weeks | 1 |
Serum creatinine mg/dL at 6 months following transplantation
| mg/dL | Deceased Donor HCV RNA PCR+ |
|---|---|
| Kidney Function at 6 Months | 1.32 (0.8 to 2.0) |
Serum creatinine mg/dL at 12 months following transplantation
| mg/dL | Deceased Donor HCV RNA PCR+ |
|---|---|
| Kidney Function at 12 Months | 1.33 (0.79 to 4.12) |
Collected over Adverse events were collected for 12 months from initiation of treatment. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| Deceased Donor HCV RNA PCR+ | 0/10 (0%) | 3/10 (30%) | 0/10 (0%) |
| Event | Deceased Donor HCV RNA PCR+ |
|---|---|
| Renal Vein ThrombosisRenal and urinary disorders | 1/10 |
| Acute Kidney InjuryRenal and urinary disorders | 1/10 |
| HematuriaRenal and urinary disorders | 1/10 |
| UrosepsisInfections and infestations | 1/10 |
| Perinephric Fluid CollectionRenal and urinary disorders | 1/10 |
| Urinary Tract InfectionInfections and infestations | 1/10 |
| Age, Continuous(years) | Deceased Donor HCV RNA PCR+ |
|---|---|
| Median | 67 (40 to 75) |
| Sex: Female, Male(Participants) | Deceased Donor HCV RNA PCR+ |
|---|---|
| Female | 3 |
| Male | 7 |
| Race (NIH/OMB)(Participants) | Deceased Donor HCV RNA PCR+ |
|---|---|
| American Indian or Alaska Native | 0 |
| Asian | 1 |
| Native Hawaiian or Other Pacific Islander | 0 |
| Black or African American | 2 |
| White | 7 |
| More than one race | 0 |
| Unknown or Not Reported | 0 |
| Primary Cause of Renal Failure(Participants) | Deceased Donor HCV RNA PCR+ |
|---|---|
| Hypertension | 4 |
| Polycystic Kidney Disease | 2 |
| Glomerulonephritis | 2 |
| Nephrolithiasis | 1 |
| Reflux Nephropathy | 1 |
| Blood Type(Participants) | Deceased Donor HCV RNA PCR+ |
|---|---|
| O | 4 |
| A or AB | 5 |
| B | 1 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: Undecided — Peer reviewed publications
This study is completed, as verified in Sep 2021. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Johns Hopkins University