End Stage Renal Disease, Hepatitis C
Conditions
Brief summary
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 2 weeks post-renal transplant.
Detailed description
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 2 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 2 weeks of G-P as prophylaxis for HCV D+/R- kidney transplant.
Interventions
Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant.
Sponsors
Johns Hopkins University
Study design
Allocation
NA
Intervention model
SINGLE_GROUP
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
Recipient Inclusion Criteria: * Participants ≥ 18 years old * On the deceased donor kidney waitlist at Johns Hopkins Hospital * Awaiting a first or second kidney transplant * No available living kidney donors * On hemodialysis or peritoneal dialysis or stage 5 chronic kidney disease (CKD) defined as a glomerular filtration rate \<15 ml/min for ≥ past 90 days * HCV-uninfected (by both antibody and RNA PCR) and without any behavioral risk factors for contracting HCV other than being on hemodialysis * Calculated panel reactive anti-human leukocyte antigens (anti-HLA) antibody (flow cPRA) below 80% Recipient
Exclusion criteria
* Plan to receive a multi-organ transplant * Plan to receive a dual kidney transplant (including en bloc) * History of prior solid organ transplant other than first kidney transplant * Participating in another study that involves an intervention or investigational product * Plan to receive a blood type incompatible kidney * History of human immunodeficiency (HIV), hepatitis C (HCV), or active hepatitis B (HBV) infection, defined as being on active antiviral treatment for HBV, detectable hepatitis B surface Ag or detectable hepatitis B DNA * Unable to safely substitute or discontinue a medication that is contraindicated with the study medication * Psychiatric or physical illness that in the opinion of the investigator would make it unsafe to proceed with transplantation or interfere with the ability of the subject to participate in the study
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA | 12 weeks after completing therapy | This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment (Number of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ)). |
Countries
United States
Participant flow
Participants by arm
| Arm | Count |
|---|---|
| Deceased Donor HCV RNA PCR+ Participants who receive a kidney from HCV RNA PCR + deceased donor will receive glecaprevir/pibrentasvir 300 mg/120 mg once daily by mouth for 2 weeks
Glecaprevir/pibrentasvir: Glecaprevir/pibrentasvir 300mg/120mg once daily by mouth for 2 weeks post-transplant. | 10 |
| Total | 10 |
Baseline characteristics
| Characteristic | Deceased Donor HCV RNA PCR+ |
|---|---|
| Age, Categorical <=18 years | 0 Participants |
| Age, Categorical >=65 years | 4 Participants |
| Age, Categorical Between 18 and 65 years | 6 Participants |
| Age, Continuous | 60 years |
| Race/Ethnicity, Customized Race Asian | 2 Participants |
| Race/Ethnicity, Customized Race Black | 5 Participants |
| Race/Ethnicity, Customized Race White | 3 Participants |
| Region of Enrollment United States | 10 Participants |
| Sex: Female, Male Female | 4 Participants |
| Sex: Female, Male Male | 6 Participants |
Adverse events
| Event type | EG000 affected / at risk |
|---|---|
| deaths Total, all-cause mortality | 0 / 10 |
| other Total, other adverse events | 8 / 10 |
| serious Total, serious adverse events | 4 / 10 |
Outcome results
Primary
Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA
This is the number of participants with undetectable hepatitis C RNA in the blood at 12 weeks after stopping treatment (Number of kidney transplant recipients with HCV RNA \< Lower Limit Of Quantification (LLOQ)).
Time frame: 12 weeks after completing therapy
| Arm | Measure | Value (COUNT_OF_PARTICIPANTS) |
|---|---|---|
| Deceased Donor HCV RNA PCR+ | Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA | 10 Participants |