Phase 4
Completed N=21
HCV Treatment Immune Response With Grazoprevir/Elbasvir Before or After Renal Transplant
Hepatitis C · Renal Insufficiency, Chronic · Disorder of Transplanted Kidney
Source: ClinicalTrials.gov NCT02902120 ↗
Enrolled (actual)
21
Serious AEs
28.6%
Results posted
Nov 2022
Primary outcomePrimary: SVR 12 — 19; 1; 1 Participants
◆ Published Evidence
No publication linked
No peer-reviewed publication reporting this trial's results has been linked yet. This can indicate results are unpublished — a known publication-bias signal. We re-check periodically.
Summary
The purpose of this study is to determine whether patients treated for chronic hepatitis C (HCV) with zepatier (grazoprevir/elbasvir) prior to kidney transplant will have a stronger immune response compared to patients treated after kidney transplant. 25 patients with chronic kidney disease (CKD) and HCV will be treated with zepatier and 25 kidney transplant recipients with chronic kidney disease will be treated with zepatier. Blood markers of immune function will be monitored in both groups to determine their response to therapy.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY SVR 12 |
19; 1; 1 | — |
| SECONDARY Change in T Cell Response |
29.15; 21.83; 20.5; 12.73; 6.14; 5.03 | — |
| SECONDARY Change in T Cell Immunophenotypes |
70.64; 65.4; 65.1 | — |
| SECONDARY Quantification of Antiviral Cytokines |
9.67; 7.26; 7.26; 4.45 | — |
| SECONDARY Safety as Assessed by Adverse Event Monitoring, Including Routine Lab Work |
21; 0; 6; 15; 4; 17 | — |
| SECONDARY Kidney Function |
5; 16; 4; 17 | — |
| SECONDARY Kidney Allograft Rejection |
1; 1; 19 | — |
Eligibility Criteria
Inclusion Criteria
- At least 18 years of age at the time of screening
- Have stable renal function for one month (30 days) prior to enrollment
- Have Chronic HCV infection prior to transplantation with documented HCV viremia ≥ 1,000 IU/ml at screening and either documented HCV Ab positivity or HCV viremia ≥ 1,000 IU/ml at least 6 months prior to enrollment.
- Documented genotype 1 HCV infection prior to enrollment and after their transplant in the post-transplantation cohort
- HCV disease staging within 12 months prior to enrollment by liver biopsy, transient elastography, or biochemical testing
- Be able to give informed consent and comply with study guidelines
- Women of childbearing age will be required to have a negative pregnancy test at enrollment and use birth control throughout the duration of treatment.
Inclusion Criteria Specific to the Pre-transplant Arm
Patients will either be:
- On the transplant waiting list followed by the University of Maryland's nephrology clinic or the Baltimore VA's nephrology clinic
- On chronic hemodialysis not yet on the transplant list and followed in the University's hemodialysis center or in the University's nephrology clinic
- Have chronic kidney disease with GFR 350 within 6 months prior to enrollment
- Albumin < 3g/dL at the time of enrollment
- Platelet count < 75 at the time of enrollment
- History of clinically significant allergy or adverse event with protease inhibitors
- Evidence of the acquisition of HCV at the time of or after transplantation
- Pregnant or breastfeeding women
- Cyclosporine; St. John's Wort; Efavirenz; Phenytoin; Carbamazepine; Bosentan; HIV protease inhibitors; modafinil; ketoconazole; or rifampin use within 7 days of enrollment
- Coadministration of more than 20 mg atorvastatin; 10 mg rosuvastatin; 20 mg of fluvastatin, lovastatin or simvastatin
Data sourced from ClinicalTrials.gov (NCT02902120). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication. Informational only — not medical advice.