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Multi-center Study to Transplant Hepatitis-C Infected Kidneys
Phase 4 trial testing glecaprevir/pibrentasvir treatment in Renal Failure Chronic in 30 participants. Completed in 31 December 2021.
| Lead sponsor | Raymond Chung |
|---|---|
| Phase | Phase 4 |
| Status | Completed |
| Study type | INTERVENTIONAL |
| Allocation | na |
| Design | single group |
| Masking | none |
| Primary purpose | prevention |
| Enrollment | 30 |
| Start date | 10 April 2019 |
| Primary completion | 20 March 2020 |
| Estimated completion | 31 December 2021 |
| Sites | 7 locations across United States |
Raymond Chung — full company profile →
Adults 21 to 65, any sex, with Renal Failure Chronic or Hepatitis C. Patients with the condition only — healthy volunteers not accepted.
Per-arm endpoint measurements with 95% confidence intervals where reported. Source: trial results section.
HCV RNA \< LLOQ 12 weeks after the last actual dose of G/P
| Group | Value | 95% CI |
|---|---|---|
| NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1) | 30 |
HCV RNA \> LLOQ during G/P treatment
| Group | Value | 95% CI |
|---|---|---|
| NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1) | 12 |
HCV RNA \> LLOQ after completion of G/P treatment and prior HCV RNA \< LLOQ while on treatment
| Group | Value | 95% CI |
|---|---|---|
| NAT+ Kidney Transplant Treatment With Glecaprevir/Pibrentasvir Fixed Dose Combination (Arm 1) | 0 |
Time frame: Baseline (day of transplant) to one year post transplant (1 year total). Reporting threshold: 5%. Adverse-event reports describe events observed during the trial — not all are caused by the drug.
| Reaction | System | NAT+ Kidney Transplant Tre… |
|---|---|---|
| neutrophil count decreased | Blood and lymphatic system disorders | — |
| acute cellular rejection | Immune system disorders | — |
| hypotension | Respiratory, thoracic and mediastinal disorders | — |
| gastritis | Gastrointestinal disorders | — |
| febrile neutropenia | Blood and lymphatic system disorders | — |
| postoperative hemorrhage | Injury, poisoning and procedural complications | — |
| acute kidney injury | Renal and urinary disorders | — |
| drug toxicity due to accidental overdosage | Injury, poisoning and procedural complications | — |
| heart failure | Cardiac disorders | — |
| stroke | Nervous system disorders | — |
| vomiting | Gastrointestinal disorders | — |
| hemorrhoidal hemorrhage | Blood and lymphatic system disorders | — |
| small intestinal obstruction | Gastrointestinal disorders | — |
| ileus | Gastrointestinal disorders | — |
| renal calculi | Renal and urinary disorders | — |
| abdominal infection | Gastrointestinal disorders | — |
| coronavirus infection | Infections and infestations | — |
| post procedural urine leak | Renal and urinary disorders | — |
| fever | Infections and infestations | — |
| renal graft function delayed | Renal and urinary disorders | — |
| dysuria | Renal and urinary disorders | — |
| cytomegalovirus infection reactivation | Infections and infestations | — |
| sepsis | Infections and infestations | — |
| constipation | Gastrointestinal disorders | — |
| syncope | Respiratory, thoracic and mediastinal disorders | — |
| Reaction | System | NAT+ Kidney Transplant Tre… |
|---|---|---|
| dizziness | Nervous system disorders | — |
| abdominal pain | Gastrointestinal disorders | — |
| hyperglycemia | Endocrine disorders | — |
| hypertension | Vascular disorders | — |
| hypotension | Vascular disorders | — |
| tremor | Nervous system disorders | — |
| hyperkalemia | Renal and urinary disorders | — |
| white blood cell count decreased | Blood and lymphatic system disorders | — |
| creatinine increased | Renal and urinary disorders | — |
| dyspnea | Respiratory, thoracic and mediastinal disorders | — |
| edema limbs | Vascular disorders | — |
| fatigue | General disorders | — |
| gastritis | Gastrointestinal disorders | — |
| headache | Nervous system disorders | — |
| nausea | General disorders | — |
| urinary retention | Renal and urinary disorders | — |
| urinary tract infection | Renal and urinary disorders | — |
| vomiting | Gastrointestinal disorders | — |
| acute cellular rejection | Immune system disorders | — |
| acute kidney injury | Renal and urinary disorders | — |
| anemia | Blood and lymphatic system disorders | — |
| anxiety | Psychiatric disorders | — |
| bladder spasm | Renal and urinary disorders | — |
| chills | General disorders | — |
| constipation | Gastrointestinal disorders | — |
| cytomegalovirus infection reactivation | Infections and infestations | — |
| gastroesophageal reflux disease | Gastrointestinal disorders | — |
| nasal congestion | Respiratory, thoracic and mediastinal disorders | — |
| neutrophil count decreased | Blood and lymphatic system disorders | — |
| pain in extremity | Musculoskeletal and connective tissue disorders | — |
| platelet count decreased | Blood and lymphatic system disorders | — |
| renal graft function delayed | Renal and urinary disorders | — |
Most-reported serious reactions: neutrophil count decreased, acute cellular rejection, hypotension, gastritis, febrile neutropenia, postoperative hemorrhage, acute kidney injury, drug toxicity due to accidental overdosage.
Data from ClinicalTrials.gov NCT03781726 adverse events section.
Open label multi center study for the donation of HCV positive kidneys to HCV negative recipients with interventional treatment to prevent HCV transmission upon transplantation.
4 peer-reviewed publications reference this trial (live from Europe PMC):
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Drug Landscape aggregates and links these public records for informational use only. Always verify against the primary source before clinical or regulatory decisions. Canonical URL: https://druglandscape.com/trial/NCT03781726.
Primary sources · FDA · ClinicalTrials.gov · EMA · SEC EDGAR · ChEMBL · Wikidata · full sourcing