Trial Outcomes & Findings for Multi-center Study to Transplant Hepatitis-C Infected Kidneys (NCT NCT03781726)
NCT ID: NCT03781726
Last Updated: 2022-01-26
Results Overview
HCV RNA \< LLOQ 12 weeks after the last actual dose of G/P
Recruitment status
COMPLETED
Study phase
PHASE4
Target enrollment
30 participants
Primary outcome timeframe
12 weeks post treatment
Results posted on
2022-01-26
Participant Flow
Participant milestones
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Overall Study
STARTED
|
30
|
|
Overall Study
COMPLETED
|
28
|
|
Overall Study
NOT COMPLETED
|
2
|
Reasons for withdrawal
Withdrawal data not reported
Baseline Characteristics
One patient missing BMI data
Baseline characteristics by cohort
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 Participants
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Age, Continuous
|
57 years
n=30 Participants
|
|
Sex: Female, Male
Female
|
9 Participants
n=30 Participants
|
|
Sex: Female, Male
Male
|
21 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Hispanic or Latino
|
1 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Not Hispanic or Latino
|
29 Participants
n=30 Participants
|
|
Ethnicity (NIH/OMB)
Unknown or Not Reported
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
American Indian or Alaska Native
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Asian
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Native Hawaiian or Other Pacific Islander
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Black or African American
|
9 Participants
n=30 Participants
|
|
Race (NIH/OMB)
White
|
20 Participants
n=30 Participants
|
|
Race (NIH/OMB)
More than one race
|
0 Participants
n=30 Participants
|
|
Race (NIH/OMB)
Unknown or Not Reported
|
1 Participants
n=30 Participants
|
|
Kidney disease etiology
Diabetic nephropathy
|
11 Participants
n=30 Participants
|
|
Kidney disease etiology
Hypertension
|
9 Participants
n=30 Participants
|
|
Kidney disease etiology
Polycystic kidney disease
|
3 Participants
n=30 Participants
|
|
Kidney disease etiology
Congenital/genetic
|
2 Participants
n=30 Participants
|
|
Kidney disease etiology
IgA nephropathy
|
3 Participants
n=30 Participants
|
|
Kidney disease etiology
Other
|
2 Participants
n=30 Participants
|
|
On dialysis at baseline
Yes
|
27 Participants
n=30 Participants
|
|
On dialysis at baseline
No
|
3 Participants
n=30 Participants
|
|
Time from consent to transplant
|
6.29 Weeks
n=30 Participants
|
|
Time spent on waitlist at time of consent
|
137 Weeks
n=30 Participants
|
|
BMI
|
29.5 kg/m^2
n=29 Participants • One patient missing BMI data
|
PRIMARY outcome
Timeframe: 12 weeks post treatmentHCV RNA \< LLOQ 12 weeks after the last actual dose of G/P
Outcome measures
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 Participants
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Number of Participants With Undetectable HCV
|
30 Participants
|
SECONDARY outcome
Timeframe: During 8 week treatment courseHCV RNA \> LLOQ during G/P treatment
Outcome measures
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 Participants
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Percentage of Subjects With On-treatment Virologic Failure
|
12 Participants
|
SECONDARY outcome
Timeframe: During 12 week post treatment follow-upHCV RNA \> LLOQ after completion of G/P treatment and prior HCV RNA \< LLOQ while on treatment
Outcome measures
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 Participants
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Percentage of Subjects With Post-treatment Virologic Relapse
|
0 Participants
|
Adverse Events
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
Serious events: 20 serious events
Other events: 27 other events
Deaths: 2 deaths
Serious adverse events
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 participants at risk
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
febrile neutropenia
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Injury, poisoning and procedural complications
postoperative hemorrhage
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Immune system disorders
acute cellular rejection
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
acute kidney injury
|
3.3%
1/30 • Number of events 4 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Injury, poisoning and procedural complications
drug toxicity due to accidental overdosage
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Cardiac disorders
heart failure
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Nervous system disorders
stroke
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
vomiting
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Respiratory, thoracic and mediastinal disorders
hypotension
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
gastritis
|
6.7%
2/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
hemorrhoidal hemorrhage
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
small intestinal obstruction
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
ileus
|
3.3%
1/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
renal calculi
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
abdominal infection
|
3.3%
1/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Infections and infestations
coronavirus infection
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
post procedural urine leak
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Infections and infestations
fever
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
renal graft function delayed
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
dysuria
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Infections and infestations
cytomegalovirus infection reactivation
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Infections and infestations
sepsis
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
constipation
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Respiratory, thoracic and mediastinal disorders
syncope
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Cardiac disorders
chest pain
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
urinary tract obstruction
|
3.3%
1/30 • Number of events 1 • Baseline (day of transplant) to one year post transplant (1 year total)
|
Other adverse events
| Measure |
NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1)
n=30 participants at risk
8 weeks of HCV treatment with combination tablet of glecaprevir and pibrentasvir
glecaprevir/pibrentasvir treatment: combination treatment with glecaprevir and pibrentasvir fixed dose tablet.
|
|---|---|
|
Gastrointestinal disorders
abdominal pain
|
20.0%
6/30 • Number of events 6 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Immune system disorders
acute cellular rejection
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
acute kidney injury
|
6.7%
2/30 • Number of events 5 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
anemia
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Psychiatric disorders
anxiety
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
bladder spasm
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
General disorders
chills
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
constipation
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
creatinine increased
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Infections and infestations
cytomegalovirus infection reactivation
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Nervous system disorders
dizziness
|
23.3%
7/30 • Number of events 8 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Respiratory, thoracic and mediastinal disorders
dyspnea
|
10.0%
3/30 • Number of events 4 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Vascular disorders
edema limbs
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
General disorders
fatigue
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
gastritis
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
gastroesophageal reflux disease
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Nervous system disorders
headache
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Endocrine disorders
hyperglycemia
|
20.0%
6/30 • Number of events 6 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
hyperkalemia
|
13.3%
4/30 • Number of events 5 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Vascular disorders
hypertension
|
16.7%
5/30 • Number of events 5 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Vascular disorders
hypotension
|
16.7%
5/30 • Number of events 6 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Respiratory, thoracic and mediastinal disorders
nasal congestion
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
General disorders
nausea
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
neutrophil count decreased
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Musculoskeletal and connective tissue disorders
pain in extremity
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
platelet count decreased
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
renal graft function delayed
|
6.7%
2/30 • Number of events 2 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Nervous system disorders
tremor
|
16.7%
5/30 • Number of events 5 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
urinary retention
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Renal and urinary disorders
urinary tract infection
|
10.0%
3/30 • Number of events 7 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Gastrointestinal disorders
vomiting
|
10.0%
3/30 • Number of events 3 • Baseline (day of transplant) to one year post transplant (1 year total)
|
|
Blood and lymphatic system disorders
white blood cell count decreased
|
13.3%
4/30 • Number of events 5 • Baseline (day of transplant) to one year post transplant (1 year total)
|
Additional Information
Results disclosure agreements
- Principal investigator is a sponsor employee
- Publication restrictions are in place