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A Phase 2 Extension Study of Study GCS-100-CS-4002

NCT02155673 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 92

Last updated 2016-12-26

No results posted yet for this study

Summary

The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.

Conditions

Interventions

DRUG

GCS-100

1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.

Sponsors & Collaborators

  • La Jolla Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • George Tidmarsh, MD, PhD

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

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

Timeline & Regulatory

Start
2014-01-31
Primary Completion
2016-05-31
Completion
2016-06-30

Countries

  • United States

Study Locations

More Related Trials

Entities

Diseases

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 NCT02155673 on ClinicalTrials.gov