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Monoclonal Antibodies

GCS-100 1 mg for Diabetic Kidney Disease

Phase 2
Waitlist Available
Research Sponsored by La Jolla Pharmaceutical Company
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial
Must have
Be older than 18 years old
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 26 weeks
Awards & highlights

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).

Eligible Conditions
  • Diabetic Kidney Disease

Timeline

Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~26 weeks
This trial's timeline: 3 weeks for screening, Varies for treatment, and 26 weeks for reporting.

Treatment Details

Study Objectives

Outcome measures can provide a clearer picture of what you can expect from a treatment.
Primary outcome measures
The change in eGFR from Screening to measurements taken at Week 26
Secondary outcome measures
Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26
Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26
Incidence of major cardiac events
+1 more

Trial Design

4Treatment groups
Experimental Treatment
Placebo Group
Group I: GCS-100 9 mgExperimental Treatment1 Intervention
Dose level 3 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months
Group II: GCS-100 3 mgExperimental Treatment1 Intervention
Dose level 2 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months
Group III: GCS-100 1 mgExperimental Treatment1 Intervention
Dose level 1 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months
Group IV: Normal Saline Solution 0.9%Placebo Group1 Intervention
Placebo - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
GCS-100
2013
Completed Phase 2
~260

Find a Location

Who is running the clinical trial?

La Jolla Pharmaceutical CompanyLead Sponsor
23 Previous Clinical Trials
2,341 Total Patients Enrolled
George F Tidmarsh, MD, PhDStudy DirectorLa Jolla Pharmaceutical Company
1 Previous Clinical Trials
344 Total Patients Enrolled

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
Recent research and studies
clinicaltrials.govStudy
A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
2015. "A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT02312050.
All > Chronic Kidney Disease
~37 spots leftby Apr 2025
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