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A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

NCT02312050 · Status: UNKNOWN · Phase: PHASE2 · Type: INTERVENTIONAL · Enrollment: 375

Last updated 2015-05-19

No results posted yet for this study

Summary

A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).

Conditions

  • Diabetic Chronic Kidney Disease

Interventions

DRUG

GCS-100

1 mg, 3 mg, or 9 mg IV push injections

DRUG

Placebo

Sponsors & Collaborators

  • La Jolla Pharmaceutical Company

    lead INDUSTRY

Principal Investigators

  • George F Tidmarsh, MD, PhD · La Jolla Pharmaceutical Company

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
TRIPLE
Model
SINGLE_GROUP

Eligibility

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

Timeline & Regulatory

Start
2015-03-31
Primary Completion
2016-09-30
Completion
2016-12-31

Countries

  • United States

Study Locations

More Related Trials

Entities

Drugs

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 NCT02312050 on ClinicalTrials.gov