Trial Outcomes & Findings for Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors (NCT NCT03627299)

NCT ID: NCT03627299

Last Updated: 2021-10-19

Results Overview

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

• Recruitment status: COMPLETED
• Study phase: PHASE4
• Target enrollment: 11 participants
• Primary outcome timeframe: 12 weeks after completing therapy
• Results posted on: 2021-10-19

Participant Flow

Of 11 participants who signed consent, 10 received organ offers from HCV+ deceased donors. The remaining participant did not receive an offer before enrollment in the study closed.

Participant milestones

Measure	Deceased Donor HCV RNA PCR+ 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 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

Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive 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 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Age, Continuous	67 years n=5 Participants
Sex: Female, Male Female	3 Participants n=5 Participants
Sex: Female, Male Male	7 Participants n=5 Participants
Race (NIH/OMB) American Indian or Alaska Native	0 Participants n=5 Participants
Race (NIH/OMB) Asian	1 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	2 Participants n=5 Participants
Race (NIH/OMB) White	7 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 Renal Failure Hypertension	4 Participants n=5 Participants
Primary Cause of Renal Failure Polycystic Kidney Disease	2 Participants n=5 Participants
Primary Cause of Renal Failure Glomerulonephritis	2 Participants n=5 Participants
Primary Cause of Renal Failure Nephrolithiasis	1 Participants n=5 Participants
Primary Cause of Renal Failure Reflux Nephropathy	1 Participants n=5 Participants
Blood Type O	4 Participants n=5 Participants
Blood Type A or AB	5 Participants n=5 Participants
Blood Type B	1 Participants n=5 Participants

PRIMARY outcome

Timeframe: 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. Proportion of kidney transplant recipients with HCV RNA < Lower Limit Of Quantification (LLOQ) at week 12

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Viral Response at Week 12	10 Participants

PRIMARY outcome

Timeframe: 4 weeks after transplant

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.

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P	0 Participants

SECONDARY outcome

Timeframe: 1 week after completing therapy

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

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Viral Response at 1 Week	8 Participants

SECONDARY outcome

Timeframe: 2 weeks after completing therapy

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

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Viral Response at 2 Weeks	10 Participants

SECONDARY outcome

Timeframe: 4 weeks after completing therapy

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

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Viral Response at 4 Weeks	10 Participants

SECONDARY outcome

Timeframe: 8 weeks after completing therapy

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

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Viral Response at 8 Weeks	10 Participants

SECONDARY outcome

Timeframe: week 12 after discontinuation of therapy

Number of kidney transplant recipients that become reactive for HCV antibody

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Antibody Development	9 Participants

SECONDARY outcome

Timeframe: Baseline prior to induction therapy

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.

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
T-cell Response at Baseline No T-cell response at baseline	6 Participants
T-cell Response at Baseline T-cell response to 1 peptide at baseline	1 Participants
T-cell Response at Baseline T-cell response to 2 peptides at baseline	2 Participants
T-cell Response at Baseline T-cell response to 3 peptides at baseline	1 Participants

SECONDARY outcome

Timeframe: Week12 after discontinuation of therapy

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.

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
T-cell Response at 12 Weeks No T-cell response at 12 weeks	5 Participants
T-cell Response at 12 Weeks T-cell response to 1 peptide at 12 weeks	3 Participants
T-cell Response at 12 Weeks T-cell response to 2 peptides at 12 weeks	1 Participants
T-cell Response at 12 Weeks T-cell response to 3 peptides at 12 weeks	1 Participants

SECONDARY outcome

Timeframe: 6 months following transplant

Serum creatinine mg/dL at 6 months following transplantation

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=10 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Kidney Function at 6 Months	1.32 mg/dL Interval 0.8 to 2.0

SECONDARY outcome

Timeframe: 12 months following transplant

Population: One participant did not have serum creatinine checked at 12 months post-transplantation.

Serum creatinine mg/dL at 12 months following transplantation

Outcome measures

Measure	Deceased Donor HCV RNA PCR+ n=9 Participants 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 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Kidney Function at 12 Months	1.33 mg/dL Interval 0.79 to 4.12

Adverse Events

Deceased Donor HCV RNA PCR+

Serious events: 3 serious events

Other events: 0 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 300 mg glecaprevir/pibrentasivir 120 mg once daily by mouth for 4 weeks 300mg glecaprevir/pibrentasivir 120mg: 300mg glecaprevir/pibrentasivir 120mg 4 weeks post-transplant
Renal and urinary disorders Renal Vein Thrombosis	10.0% 1/10 • Number of events 1 • Adverse events were collected for 12 months from initiation of treatment
Renal and urinary disorders Acute Kidney Injury	10.0% 1/10 • Number of events 1 • Adverse events were collected for 12 months from initiation of treatment
Renal and urinary disorders Hematuria	10.0% 1/10 • Number of events 1 • Adverse events were collected for 12 months from initiation of treatment
Infections and infestations Urosepsis	10.0% 1/10 • Number of events 1 • Adverse events were collected for 12 months from initiation of treatment
Renal and urinary disorders Perinephric Fluid Collection	10.0% 1/10 • Number of events 1 • Adverse events were collected for 12 months from initiation of treatment
Infections and infestations Urinary Tract Infection	10.0% 1/10 • Number of events 2 • Adverse events were collected for 12 months from initiation of treatment

Other adverse events

Adverse event data not reported

Additional Information

Christine Durand, MD

Johns Hopkins University

Phone: 410-955-5684

Email: ChristineDurand@jhmi.edu

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place