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

NCT03506854 | Completed Phase 1 FDA Drug

• 1 other identifier: ISIS 681257-CS12
• Study Type: interventional
• Target: 16
• Locations: 2 countries
• Sites: 3

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

Conditions

Renal Impairment

Outcome Measures

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.

  The plasma concentrations of ISIS 681257 will be measured.

  Day 31

Secondary Outcomes (2)

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

  Day 31

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

  Day 1

Study Arms (2)

Normal Renal Function

EXPERIMENTAL

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.

Drug: ISIS 681257

Moderate Renal Impairment

EXPERIMENTAL

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

Drug: ISIS 681257

Interventions

ISIS 681257 DRUG

Xmg dose administered as a subcutaneous injection

Moderate Renal Impairment; Normal Renal Function

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: Yes
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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)

You may not qualify if:

• 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

Sponsors & Collaborators

• Akcea Therapeutics: lead
• Ionis Pharmaceuticals, Inc.: collaborator

Study Sites (3)

Clinical Site

Orlando, Florida, 32809, United States

Location

Clinical Site

Knoxville, Tennessee, 37920, United States

Location

Clinical Site

Québec, H7V4B3, Canada

Location

Related Publications (1)

• Milosavljevic MN, Stefanovic SM, Pejcic AV. Potential Novel RNA-Targeting Agents for Effective Lipoprotein(a) Lowering: A Systematic Assessment of the Evidence From Completed and Ongoing Developmental Clinical Trials. J Cardiovasc Pharmacol. 2023 Jul 1;82(1):1-12. doi: 10.1097/FJC.0000000000001429.

  PMID: 37070852 DERIVED

MeSH Terms

Conditions

Renal Insufficiency

Condition Hierarchy (Ancestors)

Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Design

• Study Type: interventional
• Phase: phase 1
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SEQUENTIAL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: April 3, 2018
• First Posted: April 24, 2018
• Study Start: March 20, 2018
• Primary Completion: October 11, 2018
• Study Completion: October 11, 2018
• Last Updated: May 22, 2019

Record last verified: 2019-05

Data Sharing

• IPD Sharing: Will not share

Locations

US (2); CA (1)