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A Study of Safety, PK, & PD of ISIS 416858 Administered Subcutaneously to Patients With End-Stage Renal Disease on Hemodialysis

NCT02553889 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 49

Last updated 2016-12-13

No results posted yet for this study

Summary

Evaluation of safety, tolerability, PK and PD of ISIS 416858 in patients with end-stage renal disease (ESRD) receiving chronic hemodialysis.

Conditions

  • End-stage Renal Disease (ESRD)

Interventions

DRUG

ISIS 416858

subcutaneous injection

DRUG

Placebo

subcutaneous injection

Sponsors & Collaborators

  • Bayer

    collaborator INDUSTRY

  • Ionis Pharmaceuticals, Inc.

    lead INDUSTRY

Principal Investigators

  • Sanjay Bhanot, MD · Ionis Pharmaceuticals

Study Design

Allocation
RANDOMIZED
Purpose
PREVENTION
Masking
QUADRUPLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2015-10-31
Primary Completion
2016-11-30
Completion
2016-11-30

Countries

  • Canada

Study Locations

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Entities

Drugs
Companies

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT02553889 on ClinicalTrials.gov