Trials / Completed
CompletedNCT02553889
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
A Phase 2, Randomized, Double Blind, Placebo Controlled Study of the Safety, PK, and PD of Multiple Doses of ISIS 416858 (ISIS-FXI RX), Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
- Status
- Completed
- Phase
- Phase 2
- Study type
- Interventional
- Enrollment
- 49 (actual)
- Sponsor
- Ionis Pharmaceuticals, Inc. · Industry
- Sex
- All
- Age
- 18 Years – 80 Years
- Healthy volunteers
- Not accepted
Summary
Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.
Detailed description
Evaluation of Safety, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis. The overall objectives are to evaluate the safety, tolerability, pharmacokinetics, and pharmacodynamics of ISIS 416858 in ESRD patients on hemodialysis.
Conditions
Interventions
| Type | Name | Description |
|---|---|---|
| DRUG | ISIS 416858 | subcutaneous injection |
| DRUG | Placebo | subcutaneous injection |
Timeline
- Start date
- 2015-10-01
- Primary completion
- 2016-11-01
- Completion
- 2016-11-01
- First posted
- 2015-09-18
- Last updated
- 2016-12-13
Locations
8 sites across 1 country: Canada
Source: ClinicalTrials.gov record NCT02553889. Inclusion in this directory is not an endorsement.