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UNKNOWNPHASE2

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

A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

NCT02312050•La Jolla Pharmaceutical Company

View on ClinicalTrials.gov

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).

Detailed Description

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes (de Boer et. al., 2011, Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney (Dang et. al., 2012, Fernandes Bertocchi et. al., 2008, Henderson et. al., 2008). GCS-100 is a galectin- 3 antagonist that has been shown to reduce fibrosis pre-clinically. Based on the role of galectin-3 and fibrosis in kidney disease, the Sponsor believes GCS-100 may be effective at treating patients with CKD caused by diabetes.

Eligibility

Age

18 - 90 years

Sex

ALL

Healthy Volunteers

Inclusion Criteria

•1. Patient is capable of understanding the purpose and risks of the study and is able to provide written informed consent.
•2. Patient is ≥ 18 and ≤ 90 years of age.
•3. Patient has a baseline eGFR of 15 to \< 45 mL/min/1.73m2, defined as the average of 2 measurements collected at Screening Visits 1 and 2, and determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
•4. Patients with diabetic CKD diagnosis \> 12 months, and if requiring renin-angiotensin-aldosterone system (RAAS) blockade medications, must be receiving stable doses (i.e., not requiring modification) for the 3 months prior to first study drug dose.
•5. Stable eGFR as measured by a less than 25% variability of each Screening value from the average of the 2 Screening values taken no less than 5 days and no more than 10 days apart.
•6. Patient is willing and able to comply with all protocol requirements.
•7. Female patients of childbearing potential (i.e., women who have not been surgically sterilized or who have not been post-menopausal for at least 1 year) and male patients with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period.

Exclusion Criteria

•1. Treatment with an experimental (unlicensed) drug within 4 weeks prior to Screening visit 1.
•2. Patients who are known to be allergic to citrus or have a history of any allergies associated with hypersensitivity to citrus.
•3. Patients who have begun new treatment with angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor blockers (MRBs), or direct renin inhibitors (DRIs) within the 3 months prior to first dose.
•4. Kidney disease known to be due to causes other than diabetes.
•5. Patients diagnosed with acute kidney injury (AKI) within the 3 months prior to first dose.
•6. Planned renal replacement therapy of any kind within 6 months of first study drug dose.
•7. Previous solid organ transplant.
•8. Evidence of persistent, uncontrolled hypertension, i.e., systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg; or evidence of persistent, uncontrolled hypotension, i.e., systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 40 mmHg at repeated measures during Screening.
•9. Patients who have Screening clinical laboratory values of:
•1. Hemoglobin: ≤ 9 g/dL
+11 more criteria

Locations (8)

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

Key Dates

Start Date

March 1, 2015

Primary Completion Date

September 1, 2016

Completion Date

December 1, 2016

Last Updated

May 19, 2015

Enrollment

375

ESTIMATED participants

Conditions

Diabetic Chronic Kidney Disease

Interventions

GCS-100

DRUG

Placebo

DRUG

Impact of Diabetes-Related Metabolic Derangements on Clinical Outcomes in Hospitalized Patients With Chronic Kidney Disease

NCT07354958

Diabetic Chronic Kidney Disease Patients

View study

Data Source & Attribution

This clinical trial information is sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

ClinicalTrials.gov last update: May 19, 2015Data synced to Clareo: March 29, 2026

Modifications: This data has been reformatted for display purposes. Eligibility criteria have been parsed into inclusion/exclusion sections. Location data has been geocoded to enable distance-based search. For the authoritative and most current information, please visit ClinicalTrials.gov.

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