Trial Outcomes & Findings for Utilization of Hepatitis C Positive Kidneys in Negative Recipients (NCT NCT03801707)
NCT ID: NCT03801707
Last Updated: 2023-09-13
Results Overview
Proportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.
Recruitment status
COMPLETED
Study phase
PHASE2/PHASE3
Target enrollment
54 participants
Primary outcome timeframe
12 weeks
Results posted on
2023-09-13
Participant Flow
54 Kidney transplant candidates were enrolled and listed on the Deceased Donor Kidney Wait-list to receive hepatitis C virus (HCV) viremic kidneys
In total 18 patients were removed from the study: 9 participants received hepatitis C virus nucleic antigen test (HCV NAT) negative kidney transplants, 8 participants were removed from the kidney transplant deceased waiting-list, and 1 participant died prior to receiving kidney transplant
Participant milestones
| Measure |
Intervention Group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Overall Study
STARTED
|
36
|
|
Overall Study
COMPLETED
|
30
|
|
Overall Study
NOT COMPLETED
|
6
|
Reasons for withdrawal
| Measure |
Intervention Group
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Overall Study
Removed from study due to reaching the study target of 30 transplant from hepatitis C viremic donors
|
6
|
Baseline Characteristics
Utilization of Hepatitis C Positive Kidneys in Negative Recipients
Baseline characteristics by cohort
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Age, Continuous
|
59 years
n=5 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=5 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=5 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Black or African American
|
5 Participants
n=5 Participants
|
|
Race (NIH/OMB)
White
|
25 Participants
n=5 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=5 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=5 Participants
|
|
Primary cause of end stage kidney diseaes
Diabetes Mellitus
|
11 Participants
n=5 Participants
|
|
Primary cause of end stage kidney diseaes
Hypertension
|
4 Participants
n=5 Participants
|
|
Primary cause of end stage kidney diseaes
Adult polycystic kidney disease
|
7 Participants
n=5 Participants
|
|
Primary cause of end stage kidney diseaes
Immunoglobin (IgA) nephropathy
|
3 Participants
n=5 Participants
|
|
Primary cause of end stage kidney diseaes
Others
|
5 Participants
n=5 Participants
|
|
Time on dialysis prior to transplant
|
12 months
n=5 Participants
|
|
Donor (D) -Recipient (R) Cytomegalovirus (CMV) status
Cytomegalovirus (CMV) Donor (D)+/ Recipient (R-)
|
10 Participants
n=5 Participants
|
|
Donor (D) -Recipient (R) Cytomegalovirus (CMV) status
CMV D+/R+
|
3 Participants
n=5 Participants
|
|
Donor (D) -Recipient (R) Cytomegalovirus (CMV) status
CMV D-/R+
|
10 Participants
n=5 Participants
|
|
Donor (D) -Recipient (R) Cytomegalovirus (CMV) status
CMV D-/R-
|
7 Participants
n=5 Participants
|
|
Insurance type
Public, Medicaid
|
2 Participants
n=5 Participants
|
|
Insurance type
Public, Medicare
|
18 Participants
n=5 Participants
|
|
Insurance type
Private
|
10 Participants
n=5 Participants
|
|
Pre-Transplant Calculated Panel Reactive Antibody (cPRA) %
|
0 percent
n=5 Participants
|
PRIMARY outcome
Timeframe: 12 weeksProportion of patients with undetectable hepatitis C virus (HCV) polymerase chain reaction (PCR) at 12 weeks after completion of HCV treatment was to test the efficacy of the treatment.
Outcome measures
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Proportion of Patients With Undetectable Hepatitis C Virus (HCV) Polymerase Chain Reaction (PCR) at 12 Weeks After Completion of HCV Treatment
|
28 Participants
|
PRIMARY outcome
Timeframe: 12 weeksElevation in liver enzyme \>5 times the upper limits, development of acute cholestatic hepatitis , or intolerance to Direct acting antiviral therapies was to test the safety of utilizing HepC positive kidneys for transplant.
Outcome measures
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
Liver enzyme elevation > 5 times upper limit
|
2 Participants
|
|
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
Acute cholestatic hepatitis
|
0 Participants
|
|
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
Medication intolerance to Direct Acting Antiviral
|
0 Participants
|
|
Elevation in Liver Enzyme >5 Times the Upper Limits, Development of Acute Cholestatic Hepatitis , or Intolerance to Direct Acting Antiviral Therapies
No significant adverse effect reported
|
28 Participants
|
SECONDARY outcome
Timeframe: 6 and 12 monthsEstimated glomerular filtration rate (eGFR) at 6 and 12 months post-transplant was to test the safety of utilizing of HepC positive kidneys.
Outcome measures
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant
eGFR at 6 months
|
54 ml/min/1.73m^2
Interval 41.0 to 68.0
|
|
Estimated Glomerular Filtration Rate (eGFR) at 6 and 12 Months Post-transplant
eGFR at 12 months
|
46 ml/min/1.73m^2
Interval 40.0 to 63.0
|
SECONDARY outcome
Timeframe: 6 and 12 monthsPatient's survival at 6 and 12 months measuring safety of utilizing of HepC positive kidneys.
Outcome measures
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Patient's Survival at 6 and 12 Months
12 months patient survival
|
30 Participants
|
|
Patient's Survival at 6 and 12 Months
6 months patient survival
|
30 Participants
|
SECONDARY outcome
Timeframe: 12 monthsGraft survival at 6 and 12 months measuring safety of utilizing HepC positive kidneys.
Outcome measures
| Measure |
Intervention Group
n=30 Participants
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Graft Survival at 6 and 12 Months
6 months graft survival
|
30 Participants
|
|
Graft Survival at 6 and 12 Months
12 months graft survival
|
30 Participants
|
Adverse Events
Intervention Group
Serious events: 0 serious events
Other events: 2 other events
Deaths: 0 deaths
Serious adverse events
Adverse event data not reported
Other adverse events
| Measure |
Intervention Group
n=30 participants at risk
kidney transplant recipients who receive kidney allograft from hepatitis C viremic donors followed by treatment with direct acting antiviral therapies.
Sofosbuvir / Velpatasvir Oral Tablet \[Epclusa\]: fixed dose combination medication once a day for 12 weeks for the treatment of hepatitis C
Glecaprevir/Pibrentasvir 100 MG-40 MG Oral Tablet \[MAVYRET\]: Three tablets once a day for 12 weeks for treatment of hepatitis C
|
|---|---|
|
Hepatobiliary disorders
Liver enzyme elevation
|
6.7%
2/30 • Number of events 2 • 25 months
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place