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Study of ISIS 681257 in Patients With Renal Impairment Compared to Healthy Patients | Clinical Trials | Clareo Health

COMPLETEDPHASE1

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

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

NCT03506854•Akcea Therapeutics

View on ClinicalTrials.gov

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

Eligibility

Age

18 - No limit years

Sex

ALL

Healthy Volunteers

Yes

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

Locations (3)

Clinical Site

Orlando, Florida, United States

Clinical Site

Knoxville, Tennessee, United States

Clinical Site

Québec, Canada

Key Dates

Start Date

March 20, 2018

Primary Completion Date

October 11, 2018

Completion Date

October 11, 2018

Last Updated

May 22, 2019

Enrollment

ACTUAL participants

Conditions

Renal Impairment

Interventions

ISIS 681257

DRUG

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ACTIVE_NOT_RECRUITINGPHASE1

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Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 22, 2019Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

Neither the United States Government nor Clareo Health make any warranties regarding the data. Check ClinicalTrials.gov frequently for updates.

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

Inclusion Criteria

Exclusion Criteria

Investigation of the Effects of Renal Impairment on the Pharmacokinetics, Safety, and Tolerability of Opemalirsen (AZD2373)

A Study of Pharmacokinetics and Safety of LY3537031 in Participants With Normal Renal Function and Participants With Renal Impairment

A Study to Test How BI 456906 is Taken up in the Blood of People With and Without Kidney Problems

A Study of RG002C0106 Injection in Adult Participants With Normal Renal Function and Mild-to-Moderate Renal Impairment

A Study to Investigate the Pharmacokinetics, Safety and Tolerability of AZD5462 in Participants With Renal Impairment

DESIR. Evaluation of the Pre-therapeutic Activity of Dihydropyrimidine dEShydrogenase (DPD) in Patients With Cancer and/or Renal Failure