Clinical trialNCT02312050UnknownPhase 2Interventional

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

SponsorLa Jolla Pharmaceutical CompanyEnrollment375Diabetic Chronic Kidney Disease

View the registry record on ClinicalTrials.gov

Summary

The lay summary the sponsor registered on ClinicalTrials.gov.

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).

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Investigators

The overall officials registered on this study. Names that resolve to a FindMyKOL profile link to it; the rest are shown as registered.

George F Tidmarsh, MD, PhD
La Jolla Pharmaceutical Company
Study Director
clinicaltrials.gov ↗

A profile link is shown only when the registered name resolves to a person record with a confident, namesake-checked match; ambiguous names stay unlinked.

Sites

8 registered facilities, with the per-site recruitment status where the registry publishes one. ClinicalTrials.gov does not publish per-site enrollment counts.

United States

Balboa Nephrology Medical Group
Chula Vista, California, United States
Balboa Nephrology Medical Group
El Centro, California, United States
Balboa Nephrology Medical Group
La Jolla, California, United States
California Institute for Renal Research
La Mesa, California, United States
Denver Nephrology
Denver, Colorado, United States
Mountain Kidney & Hypertension
Asheville, North Carolina, United States
Southeast Renal Research Institute
Chattanooga, Tennessee, United States
Clinical Advancement Center
San Antonio, Texas, United States

Site investigator names are published by ClinicalTrials.gov only while a study recruits, so completed studies list sites without them.

Drugs studied

The drug and biological interventions registered on this study, normalized to their RxNorm ingredient where possible.

GCS-100Placebo

Linked drugs open the directory filtered to KOLs working with them.clinicaltrials.gov ↗

Registration & key dates

Registry attributes as recorded on the ClinicalTrials.gov study record.

Start: 31 Mar 2015
Primary completion: 30 Sept 2016
Completion: 31 Dec 2016
Last update posted: 19 May 2015
Registered enrollment: 375
Registry id: NCT02312050

clinicaltrials.gov ↗

Source: ClinicalTrials.gov, via the CTTI AACT database, data as of 11 Nov 2026. Registry facts are shown as registered by the study sponsor; FindMyKOL does not interpret them.