drugset / Trial / NCT03358030
A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis
RandomizedParallel-groupQuadruple-blindPrevention
Summary
Evaluation of safety, tolerability, pharmacokinetics (PK) and pharmacodynamics (PD) of ISIS 416858 for up to 204 participants with ESRD receiving chronic hemodialysis as assessed by FXI activity reduction.
Timeline
- Start
- 2017-12-26
- Primary completion
- 2019-07-10
- Completion
- 2019-07-10
Drugs
| Evaluation | Drug | Modality | Dose | Route |
|---|---|---|---|---|
| Subject | ISIS 416858 | Antisense oligonucleotide | 200 mg | Subcutaneous |
| Subject | ISIS 416858 | Antisense oligonucleotide | 250 mg | Subcutaneous |
| Subject | ISIS 416858 | Antisense oligonucleotide | 300 mg | Subcutaneous |