| Trial ID: | L0789 |
| Source ID: | NCT02553889
|
| Associated Drug: |
Isis 416858
|
| Title: |
A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis
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| Acronym: |
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| Status: |
COMPLETED
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| Study Results: |
NO
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| Results: |
|
| Conditions: |
End-stage Renal Disease (ESRD)
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| Interventions: |
DRUG: ISIS 416858|DRUG: Placebo
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| Outcome Measures: |
Primary: Safety and Tolerability - evaluated by reviewing frequency and severity of Adverse events (including bleeding events) and use of concomitant medications, changes in vital signs and laboratory evaluations for all patients, The safety and tolerability of ISIS 416858 will be evaluated by reviewing frequency and severity of Adverse events (including bleeding events) and use of concomitant medications, changes in vital signs and laboratory evaluations for all patients, For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days. | Secondary: Pharmacodynamic Outcomes in FXI antigen and activity as measured by absolute change over time., Pharmacodynamic Outcomes as measured by absolute change over time for FXI antigen and activity (units/milliliter), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.|Pharmacodynamic Outcomes in FXI antigen and activity as measured by percent change over time., Pharmacodynamic Outcomes as measured by percent change over time for FXI antigen and activity (units/milliliter), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.|Pharmacodynamic Outcomes in aPTT as measured by absolute change over time., Pharmacodynamic Outcomes as measured by absolute change over time for aPTT (seconds), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.|Pharmacodynamic Outcomes in aPTT as measured by percent change over time., Pharmacodynamic Outcomes as measured by percent change over time for aPTT (seconds), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.|Pharmacodynamic Outcomes for PT and the PT derived INR as measured by absolute change over time., Pharmacodynamic Outcomes as measured by absolute change over time for PT (seconds) and the PT derived INR (International Normalization Ratio), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days.|Pharmacodynamic Outcomes for PT and the PT derived INR as measured by percent change over time., Pharmacodynamic Outcomes as measured by percent change over time for PT (seconds) and the PT derived INR (International Normalization Ratio), For the PK Cohort: Patients will be followed for 72 days. For Cohorts A and B: Patients will be followed for 162 days. | Other: Pharmacokinetic Outcome for PK Cohort of effect of dialysis on peak concentrations, Effect of dialysis on peak concentrations post single dose drug administration., Patients will be followed for 29 days for this outcome measure.|Pharmacokinetic Outcome for PK Cohort of effect of dialysis on partial area under the plasma concentration-time curve, Effect of dialysis on partial area under the plasma concentration-time curve post single dose drug administration (AUC 0-24hr)., Patients will be followed for 29 days for this outcome measure.|Pharmacokinetic Outcome for Cohorts A and B to assess steady state concentrations, Plasma will be collected at each dosing interval to assess steady state concentrations., Patients will be followed for 162 days for this outcome measure
|
| Sponsor/Collaborators: |
Sponsor: Ionis Pharmaceuticals, Inc. | Collaborators: Bayer
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| Gender: |
ALL
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| Age: |
ADULT, OLDER_ADULT
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| Phases: |
PHASE2
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| Enrollment: |
49
|
| Study Type: |
INTERVENTIONAL
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| Study Designs: |
Allocation: RANDOMIZED|Intervention Model: PARALLEL|Masking: QUADRUPLE (PARTICIPANT, CARE_PROVIDER, INVESTIGATOR, OUTCOMES_ASSESSOR)|Primary Purpose: PREVENTION
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| Start Date: |
2015-10
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| Completion Date: |
2016-11
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| Results First Posted: |
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| Last Update Posted: |
2016-12-13
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| Locations: |
Ionis Investigative Site, Edmonton, Alberta, T6G 2P4, Canada|Ionis Investigative Site, Halifax, Nova Scotia, B3H 1V8, Canada|Ionis Investigative Site, Hamilton, Ontario, L8N 4A6, Canada|Ionis Investigative Site, London, Ontario, N6A 5W9, Canada|Ionis Investigative Site, Toronto, Ontario, M5B 1W8, Canada|Ionis Investigative Site, Toronto, Ontario, M9N 1N8, Canada|Ionis Investigative Site, Montreal, Quebec, H2X 0A9, Canada|Ionis Investigative Site, Montreal, Quebec, H4J 1C5, Canada
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| URL: |
https://clinicaltrials.gov/show/NCT02553889
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