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OpenTrials
Completed

NCT Number: NCT03506854

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

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

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Key information

Conditions

Renal Impairment Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Renal Insufficiency Urogenital Diseases Urologic Diseases

Age range

18 year and older

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 1

Primary location

Clinical Site, Québec, Canada

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Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

ISIS 681257

Drug

Xmg dose administered as a subcutaneous injection

Primary outcomes

  1. 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.

    Time frame: Day 31

    The plasma concentrations of ISIS 681257 will be measured.

Secondary outcomes

  1. The incidence of adverse effects of ISIS 681257 in subjects with normal and impaired renal function.

    Time frame: Day 31

    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.

  2. The plasma protein binding of ISIS 681257 in subjects with normal and impaired renal function.

    Time frame: Day 1

    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.

Sponsors and collaborators

Lead sponsor

Akcea Therapeutics

Industry

Collaborators

  • Ionis Pharmaceuticals, Inc.

Registry information

Official study 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

Important dates

Study start
2018
Primary completion
2018
Study completion
2018
First posted
Apr 24, 2018
Registry last updated
May 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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