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A Phase 2a Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease

NCT01843790 · Status: COMPLETED · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 120

Last updated 2015-09-01

No results posted yet for this study

Summary

The primary objective of this study is to compare the change in estimated glomerular filtration rate (eGFR) from baseline to Week 8 between placebo and GCS-100 treatment. The secondary objective is to determine the safety and tolerability of GCS-100 administered for 8 weeks relative to placebo. In addition, the study will measure the effect of GCS-100 on circulating galectin-3 and other markers of disease activity.

Conditions

Interventions

DRUG

GCS-100

The amount (in mg) of GCS-100 to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The study drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.

DRUG

Placebo, Saline

The amount (in mg) of drug to be administered will be determined based on body surface area, which will be calculated based on body weight and height. The drug dose should be calculated on Day 1. Drug should be added to an infusion bag or syringe containing 0.9% Sodium Chloride Injection, USP. Drug be infused into a large vein via a large bore catheter to avoid local irritation and administered at no more than 2 mg/mL in no less than 60 mL.

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
2013-06-30
Primary Completion
2014-02-28
Completion
2014-09-30

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 NCT01843790 on ClinicalTrials.gov