NCT03627299

Renal Transplants in Hepatitis C Negative Recipients With Nucleic Acid Positive Donors

Completed Phase 4 Results posted Last updated 19 October 2021

What this trial tests

Phase 4 trial testing 300mg glecaprevir/pibrentasivir 120mg in End Stage Renal Disease in 11 participants. Completed in 20 September 2021.

Timeline

25 September 2018

Primary endpoint
19 December 2019

20 September 2021

Quick facts

Lead sponsor	Johns Hopkins University
Phase	Phase 4
Status	Completed
Study type	INTERVENTIONAL
Allocation	na
Design	single group
Masking	none
Primary purpose	treatment
Enrollment	11
Start date	25 September 2018
Primary completion	19 December 2019
Estimated completion	20 September 2021
Sites	1 location across United States

Drugs / interventions tested

• 300mg glecaprevir/pibrentasivir 120mg — full drug profile →

Conditions studied

• End Stage Renal Disease — all drugs for End Stage Renal Disease →
• Hepatitis C — all drugs for Hepatitis C →

Sponsor

Johns Hopkins University

Who can join

40 and older, any sex, with End Stage Renal Disease or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.

Results — posted to ClinicalTrials.gov

Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.

Viral Response at Week 12 Primary · 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

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	10

Number of Participants With Grade 3 or Higher Treatment-related Adverse Events Related to the Use of G-P Primary · 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; hospitalizat

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	0

Viral Response at 1 Week Secondary · 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

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	8

Viral Response at 2 Weeks Secondary · 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

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	10

Viral Response at 4 Weeks Secondary · 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

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	10

Viral Response at 8 Weeks Secondary · 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

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	10

Antibody Development Secondary · week 12 after discontinuation of therapy

Number of kidney transplant recipients that become reactive for HCV antibody

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	9

T-cell Response at Baseline Secondary · 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.

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	6
Deceased Donor HCV RNA PCR+	1
Deceased Donor HCV RNA PCR+	2
Deceased Donor HCV RNA PCR+	1

T-cell Response at 12 Weeks Secondary · 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.

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	5
Deceased Donor HCV RNA PCR+	3
Deceased Donor HCV RNA PCR+	1
Deceased Donor HCV RNA PCR+	1

Kidney Function at 6 Months Secondary · 6 months following transplant

Serum creatinine mg/dL at 6 months following transplantation

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	1.32	0.8 – 2.0

Kidney Function at 12 Months Secondary · 12 months following transplant

Serum creatinine mg/dL at 12 months following transplantation

Group	Value	95% CI
Deceased Donor HCV RNA PCR+	1.33	0.79 – 4.12

Adverse events — posted to ClinicalTrials.gov

Time frame: Adverse events were collected for 12 months from initiation of treatment. Reporting threshold: 0%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.

Deceased Donor HCV RNA PCR+

Serious: 3/10 (30%)

Deaths: 0/10

Serious adverse events (6 terms)

Reaction	System	Deceased Donor HCV RNA PCR+
Renal Vein Thrombosis	Renal and urinary disorders	—
Acute Kidney Injury	Renal and urinary disorders	—
Hematuria	Renal and urinary disorders	—
Urosepsis	Infections and infestations	—
Perinephric Fluid Collection	Renal and urinary disorders	—
Urinary Tract Infection	Infections and infestations	—

Most-reported serious reactions: Renal Vein Thrombosis, Acute Kidney Injury, Hematuria, Urosepsis, Perinephric Fluid Collection, Urinary Tract Infection.

Data from ClinicalTrials.gov NCT03627299 adverse events section.

Sponsor's own 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 4 weeks post-renal transplant.

Publications & conference data

2 peer-reviewed publications reference this trial (live from Europe PMC):

1. Four-Week Direct-Acting Antiviral Prophylaxis for Kidney Transplantation From Hepatitis C-Viremic Donors to Hepatitis C-Negative Recipients: An Open-Label Nonrandomized Study.
   Durand CM, Barnaba B, Yu S, Brown DM, et al · · 2021 · cited 34× · PMID 32894697 · DOI 10.7326/m20-1468
2. HCV-Infected Deceased Donor Kidney Transplantation-Time to Take Up the Offer.
   Reddy YNV, Reddy KP, Sise ME. · · 2020 · PMID 32317120 · DOI 10.1053/j.ajkd.2020.01.010