A Phase 2 Extension Study of Study GCS-… | Clinical Trial

Key information

Conditions

Chronic Kidney Disease Chronic Disease Disease Attributes Female Urogenital Diseases Female Urogenital Diseases and Pregnancy Complications Kidney Diseases Male Urogenital Diseases Pathologic Processes Pathological Conditions, Signs and Symptoms Renal Insufficiency Renal Insufficiency, Chronic Urogenital Diseases Urologic Diseases

Age range

18 year–80 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Phase 2

Primary location

Southwest Clinical Research Institute, LLC, Tempe, Arizona, United States

About this study

Galectin-3 contributes to fibrosis, is elevated in patients with ESRD, and correlates with adverse outcomes. Animal models with genetic knockout of galectin-3 demonstrate a reduction in structural and functional deficits in the kidney. 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.

Study GCS-100-CS-4002 is an ongoing randomized, placebo controlled study of GCS-100 in Stage 3b and 4 CKD. The objective of the study is to determine the safety and efficacy of 8 weekly injections of GCS-100 on eGFR. Patients who have completed that study without adverse safety events, may be asked to participate in this study to test the safety of prolonged administration of study drug.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent
Subject was enrolled in and completed the End of Study (Day 85) of GCS-100-CS-4002

Exclusion criteria

Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4002
Systolic blood pressure ≤90 mmHg and ≥160 mmHg and diastolic blood pressure ≤40 mmHg and ≤100 mmHg at screening
Subject has clinical laboratory results of:

Hemoglobin: ≤9g/dL
Total bilirubin: >1.5X the upper limit of normal (ULN)
ALT and/or AST: >2.5X ULN
Subject has a concomitant disease or condition, including laboratory abnormalities, which, in the opinion of the investigator, could interfere with the conduct of the study or put the subject at unacceptable risk
Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator

Treatment and study plan

GCS-100

Drug

1.5 mg/m2 or 30 mg/m2 GCS-100. GCS-100 will be administered as IV infusions once weekly for 8 weeks with a 1 week and 4 week follow-up period and then at least every 30 days for up to a total of 1 year.

Primary outcomes

Evaluation of Safety

Time frame: Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.

Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values

Sponsors and collaborators

Lead sponsor

La Jolla Pharmaceutical Company

Industry

Registry information

Important dates

Study start: 2014
Primary completion: 2016
Study completion: 2016
First posted: Jun 4, 2014
Registry last updated: Dec 26, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

Published trials that share one or more normalized conditions with this study.

Completed