Phase 4
Completed N=10
Viekira Pak or Mavyret Treatment for Patient With Chronic Kidney Disease and Hepatitis C
Chronic Kidney Disease · Chronic Hepatitis C
Source: ClinicalTrials.gov NCT02946034 ↗
Enrolled (actual)
10
Serious AEs
50.0%
Results posted
Nov 2021
Primary outcomePrimary: Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment — -0.05 ng/g
◆ 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 This can indicate results are unpublished — a known publication-bias signal.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
Open-label experimental trial of 12 weeks of Viekira Pak treatment ± ribavirin or Mavyret for adults with chronic kidney disease and hepatitis C.
Outcome Measures
| Outcome | Result | p-value |
|---|---|---|
| PRIMARY Average Change in Urine Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment |
-0.05 | — |
| PRIMARY Average Change in Urine Interleukin (IL)-6 From Baseline to Post-treatment |
5.73 | — |
| PRIMARY Average Change in Plasma Tumor Necrosis Factor (TNF)-Alpha From Baseline to Post-treatment |
6.67 | — |
| PRIMARY Average Change in Plasma Interferon Gamma-induced Protein 10 (IP-10) From Baseline to Post-treatment |
-394.57 | — |
| PRIMARY Average Change in Plasma Interferon (IFN)-Gamma From Baseline to Post-treatment |
2.01 | — |
| PRIMARY Average Change in Plasma Interleukin (IL)-6 From Baseline to Post-treatment |
-3.94 | — |
| SECONDARY Number of Patients Who Suffered Adverse Events Related to Study Drug (Safety and Tolerability) |
4 | — |
| SECONDARY Number of Patients Who Had Sustained Virologic Response at 12-weeks (SVR12) Post-treatment (Efficacy of Treatment) |
8 | — |
Eligibility Criteria
Inclusion Criteria
- Male or female ≥ 18 year of age
- HCV genotype 1 ≥ 1000 IU/mL
- 6. Estimated glomerular filtration rate 15-45mL/min/1.73m2 as estimated by CKD-Epi equation
Exclusion Criteria
- Pregnant or lactating females
- Uncontrolled depression or psychiatric disease
- History or presence of any form of cancer within 3 years of enrollment
- Experiencing life-threatening cryoglobulinemic vasculitis requiring initiation of rituximab, steroids or plasmapheresis.
- Uncontrolled cardiovascular or pulmonary disease
- Experiencing symptoms attributed to uremia
- Anticipated need to begin renal replacement therapy in the next 6 months
- History of kidney transplant
Data sourced from ClinicalTrials.gov (NCT02946034). 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.