Trial Outcomes & Findings for Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors (NCT NCT04575896)
NCT ID: NCT04575896
Last Updated: 2024-01-10
Results Overview
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)).
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
10 participants
Primary outcome timeframe
12 weeks after completing therapy
Results posted on
2024-01-10
Participant Flow
Participant milestones
| Measure |
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.
|
|---|---|
|
Overall Study
STARTED
|
10
|
|
Overall Study
COMPLETED
|
10
|
|
Overall Study
NOT COMPLETED
|
0
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
Kidney Transplants in Hepatitis C Negative Recipients With Hepatitis C Viremic Donors
Baseline characteristics by cohort
| Measure |
Deceased Donor HCV RNA PCR+
n=10 Participants
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.
|
|---|---|
|
Age, Categorical
<=18 years
|
0 Participants
n=5 Participants
|
|
Age, Categorical
Between 18 and 65 years
|
6 Participants
n=5 Participants
|
|
Age, Categorical
>=65 years
|
4 Participants
n=5 Participants
|
|
Age, Continuous
|
60 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
4 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
6 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Asian
|
2 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · Black
|
5 Participants
n=5 Participants
|
|
Race/Ethnicity, Customized
Race · White
|
3 Participants
n=5 Participants
|
|
Region of Enrollment
United States
|
10 Participants
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeks after completing therapyThis 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)).
Outcome measures
| Measure |
Deceased Donor HCV RNA PCR+
n=10 Participants
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.
|
|---|---|
|
Viral Response as Assessed by Number of Participants With Undetectable Hepatitis C RNA
|
10 Participants
|
Adverse Events
Deceased Donor HCV RNA PCR+
Serious events: 4 serious events
Other events: 8 other events
Deaths: 0 deaths
Serious adverse events
| Measure |
Deceased Donor HCV RNA PCR+
n=10 participants at risk
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.
|
|---|---|
|
Renal and urinary disorders
urinary tract infection
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Infections and infestations
sepsis
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
right iliac hematoma
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
General disorders
hypotension (orthostatic)
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
creatinine increased
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
hyperkalemia
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
acute kidney injury
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
Other adverse events
| Measure |
Deceased Donor HCV RNA PCR+
n=10 participants at risk
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.
|
|---|---|
|
General disorders
fever
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Cardiac disorders
atrial fibrillation
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
hyperkalemia
|
20.0%
2/10 • Number of events 2 • 12 weeks
|
|
Renal and urinary disorders
urinary tract infection
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Blood and lymphatic system disorders
anemia
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Renal and urinary disorders
dialysis access malfunction
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
|
Respiratory, thoracic and mediastinal disorders
flash pulmonary edema
|
10.0%
1/10 • Number of events 1 • 12 weeks
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place