A Study of ISIS 416858 Administered Subcutaneously to Participants With End-Stage Renal Disease (ESRD) on Hemodialysis

Study Results

Results available

Outcome measurements, participant flow, baseline characteristics, and adverse events have been published for this study.

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Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

PHASE2

Total Enrollment

213 participants

Study Classification

INTERVENTIONAL

Study Start Date

2017-12-26

Study Completion Date

2019-07-10

Brief Summary

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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.

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Detailed Description

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Evaluation of safety, PK, and PD of ISIS 416858 (Dose # 1, Dose #2 and Dose #3 once weekly) as compared to placebo as assessed by FXI activity reduction.

Conditions

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End-stage Renal Disease (ESRD)

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

PREVENTION

Blinding Strategy

QUADRUPLE

Participants Caregivers Investigators Outcome Assessors

Study Groups

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Placebo

Participants received placebo, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period.

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Subcutaneous injection

Cohort A: ISIS 416858, 200 mg

Participants received ISIS 416858, 200 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period.

Group Type EXPERIMENTAL

ISIS 416858

Intervention Type DRUG

Subcutaneous injection

Cohort B: ISIS 416858, 250 mg

Participants received ISIS 416858, 250 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period.

Group Type EXPERIMENTAL

ISIS 416858

Intervention Type DRUG

Subcutaneous injection

Cohort C: ISIS 416858, 300 mg

Participants received ISIS 416858, 300 mg, subcutaneously, within 2 hours post-dialysis, once weekly from Week 1 (Day 1) through Week 26 of treatment period.

Group Type EXPERIMENTAL

ISIS 416858

Intervention Type DRUG

Subcutaneous injection

Interventions

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ISIS 416858

Subcutaneous injection

Intervention Type DRUG

Placebo

Subcutaneous injection

Intervention Type DRUG

Other Intervention Names

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IONIS-FXIRx 0.9% sterile saline Riboflavin

Eligibility Criteria

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Inclusion Criteria

• End stage renal disease maintained on outpatient hemodialysis at a healthcare center for \> 3 months from screening with hemodialysis at least 3 times per week for a minimum of 9 hours per week of prescribed treatment time and plan to continue this throughout the study.

Exclusion Criteria

* Participants with a history of major medical event (previous acute coronary syndrome, stroke or transient ischemic attack or systemic thromboembolic event) within 3 months of screening, major surgery within 3 months of screening, or new major physical examination finding except for documented atrial fibrillation
* Active bleeding within the past 3 months from screening or documented bleeding diathesis (excluding uremia), coagulopathy, or recent prolonged compression time at arteriovenous fistula
* Screening values of:

* Platelet count \< 150,000 cells per millimeter cube (cells/mm\^3)
* \< 180,000 cells/mm\^3 for platelet function/activation subgroup
* International normalized ratio (INR) \> 1.4
* Activated partial thromboplastin time (aPTT) \> upper limit of normal (ULN)
* Alanine aminotransferase (ALT) or aspartate aminotransferase (AST) \> 2 x ULN
* Total bilirubin \> ULN
* Factor XI (FXI) activity \< 0.3 units per milliliter (U/mL)
* Malignancy within 5 years, except basal or squamous cell carcinoma of the skin or carcinoma in situ of the cervix that has been successfully treated. Participants with malignancies that have been treated with curative intent and which have no reoccurrence within 5 years may also be eligible if approved by Sponsor Medical Monitor.
* Within 6 months prior to screening, have any of the following:

* More than 3 episodes of severe hypoglycemia requiring the assistance of another person to actively administer carbohydrate, glucagon or other resuscitative actions
* One event of hypoglycemia in which the participant required hospitalization
* Recurrent syncope and recurrent hypotension in the inter-dialytic period requiring intervention
* Planned major surgery in the next 6 months, including participants receiving kidney transplant or participants that anticipate changing dialysis modality (i.e. hemodialysis to peritoneal dialysis)
* Concomitant use of anticoagulant/antiplatelet agents (e.g., warfarin, dabigatran, rivaroxaban, clopidogrel) that may affect coagulation (except low dose aspirin (≤ 100 mg/day) during Treatment and Post-treatment Evaluation Periods is not allowed. Stable does of heparins during dialysis are permitted
* Uncontrolled hypertension as judged by the Investigator. Participants with a pre- or post-dialysis blood pressure (BP) that is \> 180 millimeters of mercury (mmHg) on at least 3 of last 5 dialysis treatments.

Minimum Eligible Age

18 Years

Maximum Eligible Age

85 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No