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Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients

Primary Purpose

Renal Impairment

Status
Completed
Phase
Phase 1
Locations
International
Study Type
Interventional
Intervention
ISIS 681257
Sponsored by
Akcea Therapeutics
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Renal Impairment

Eligibility Criteria

18 Years - undefined (Adult, Older Adult)All SexesAccepts Healthy Volunteers

Inclusion Criteria:

  • At least 18 years old
  • BMI 18.5 to 42.0 kg/m2
  • No known diseases or significant findings on physical exam (normal renal only)
  • eGFR >/= 90 mL/min/1.73m2 (normal renal only)
  • Clinically stable (renal impaired only)
  • eGFR 30-59 mL/min/1.73m2 (renal impaired only)

Exclusion Criteria:

  • Females of childbearing potential
  • Conditions or disease that may interfere with study drug
  • Any significant diseases
  • Hypersensitivity to any drugs or similar drugs to those used in the study
  • Drug dependency or abuse
  • Previous exposure to other investigational drug within 28 days
  • Blood donations within 28 days

Sites / Locations

  • Clinical Site
  • Clinical Site
  • Clinical Site

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Normal Renal Function

Moderate Renal Impairment

Arm Description

Subjects with normal renal function will be matched by age (±10 years), weight (± 20%), and gender to the pooled mean values of subjects with the moderate renal impairment. Subjects will receive 1 dose of ISIS 681257.

Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.

Outcomes

Primary Outcome Measures

Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.
The plasma concentrations of ISIS 681257 will be measured.

Secondary Outcome Measures

The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.
The safety of ISIS 681257 will be assessed by determining adverse effects by dose. Safety results in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.
The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.
Percent of ISIS 681257 bound to proteins in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.

Full Information

First Posted
April 3, 2018
Last Updated
May 20, 2019
Sponsor
Akcea Therapeutics
Collaborators
Ionis Pharmaceuticals, Inc.
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1. Study Identification

Unique Protocol Identification Number
NCT03506854
Brief Title
Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients
Official Title
Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study Of ISIS 681257 Subcutaneous Injections In Male And Female Subjects With Normal And Impaired Renal Function
Study Type
Interventional

2. Study Status

Record Verification Date
May 2019
Overall Recruitment Status
Completed
Study Start Date
March 20, 2018 (Actual)
Primary Completion Date
October 11, 2018 (Actual)
Study Completion Date
October 11, 2018 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Akcea Therapeutics
Collaborators
Ionis Pharmaceuticals, Inc.

4. Oversight

Studies a U.S. FDA-regulated Drug Product
Yes
Studies a U.S. FDA-regulated Device Product
No

5. Study Description

Brief Summary
This is a Phase 1, Multicenter, Open-Label, Parallel Group Adaptive Pharmacokinetic Single Dose Study of ISIS 681257 Subcutaneous Injections in Male And Female Subjects with Normal and Impaired Renal Function

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Renal Impairment

7. Study Design

Primary Purpose
Treatment
Study Phase
Phase 1
Interventional Study Model
Sequential Assignment
Masking
None (Open Label)
Allocation
Non-Randomized
Enrollment
16 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Normal Renal Function
Arm Type
Experimental
Arm Description
Subjects with normal renal function will be matched by age (±10 years), weight (± 20%), and gender to the pooled mean values of subjects with the moderate renal impairment. Subjects will receive 1 dose of ISIS 681257.
Arm Title
Moderate Renal Impairment
Arm Type
Experimental
Arm Description
Presence of moderate renal impairment (eGFR 30-59 mL/min/1.73m2). Subjects will receive 1 dose of ISIS 681257.
Intervention Type
Drug
Intervention Name(s)
ISIS 681257
Intervention Description
Xmg dose administered as a subcutaneous injection
Primary Outcome Measure Information:
Title
Evaluate the effect of ISIS 681257 following a single subcutaneous dose in subjects with impaired renal function relative to matched, healthy controls with normal renal function.
Description
The plasma concentrations of ISIS 681257 will be measured.
Time Frame
Day 31
Secondary Outcome Measure Information:
Title
The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.
Description
The safety of ISIS 681257 will be assessed by determining adverse effects by dose. Safety results in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.
Time Frame
Day 31
Title
The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.
Description
Percent of ISIS 681257 bound to proteins in subjects with renal impairment dosed with ISIS 681257 will be compared with those from healthy subjects dosed with ISIS 681257.
Time Frame
Day 1

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
Eligibility Criteria
Inclusion Criteria: At least 18 years old BMI 18.5 to 42.0 kg/m2 No known diseases or significant findings on physical exam (normal renal only) eGFR >/= 90 mL/min/1.73m2 (normal renal only) Clinically stable (renal impaired only) eGFR 30-59 mL/min/1.73m2 (renal impaired only) Exclusion Criteria: Females of childbearing potential Conditions or disease that may interfere with study drug Any significant diseases Hypersensitivity to any drugs or similar drugs to those used in the study Drug dependency or abuse Previous exposure to other investigational drug within 28 days Blood donations within 28 days
Facility Information:
Facility Name
Clinical Site
City
Orlando
State/Province
Florida
ZIP/Postal Code
32809
Country
United States
Facility Name
Clinical Site
City
Knoxville
State/Province
Tennessee
ZIP/Postal Code
37920
Country
United States
Facility Name
Clinical Site
City
Québec
ZIP/Postal Code
H7V4B3
Country
Canada

12. IPD Sharing Statement

Plan to Share IPD
No

Learn more about this trial

Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients

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