Clinical Trials Logo

Clinical Trial Details — Status: Withdrawn

Administrative data

NCT number NCT02333955
Other study ID # GCS-100-CS-4004
Secondary ID
Status Withdrawn
Phase Phase 2
First received December 15, 2014
Last updated January 13, 2015
Start date January 2015
Est. completion date July 2016

Study information

Verified date January 2015
Source La Jolla Pharmaceutical Company
Contact n/a
Is FDA regulated No
Health authority United States: Food and Drug Administration
Study type Interventional

Clinical Trial Summary

The primary objective of this study is to determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with Chronic Kidney Disease (CKD).


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.

This study will consist of a fixed dose of GCS-100 3mg IV push at least every 30 days for a total of 1 year with a follow-up 4 weeks after the last dose is administered.


Recruitment information / eligibility

Status Withdrawn
Enrollment 0
Est. completion date July 2016
Est. primary completion date July 2016
Accepts healthy volunteers No
Gender Both
Age group 18 Years to 80 Years
Eligibility Inclusion Criteria:

1. Subject is capable of understanding the purpose and risks of the study and is able to provide written informed consent

2. Subject was enrolled in GCS-100-CS-4003.

Exclusion Criteria:

1. Subject experienced a Grade 3 or worse adverse event related to GCS-100 in clinical study GCS-100-CS-4003.

2. Systolic blood pressure =90 mmHg and =160 mmHg and diastolic blood pressure =40 mmHg and =100 mmHg at screening

3. Subject has clinical laboratory values of:

- Hemoglobin: =9 g/dL

- Total bilirubin: >1.5X the upper limit of normal (ULN)

- ALT and/or AST: >2.5X ULN

4. 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.

5. Subject who may require renal replacement therapy within the next 2 months, at the discretion of the investigator.

Study Design

Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment


Intervention

Drug:
GCS-100
3 mg GCS-100 IV push. All doses of study drug will be administered least once monthly for a total of 1 year with a follow-up 4 weeks after the last dose is administered.

Locations

Country Name City State
United States Mountain Kidney and Hypertension Associates, PA Asheville North Carolina
United States Denver Nephrology Denver Colorado
United States California Institute of Renal Research La Mesa California
United States Clinical Advancement Center, PLLC San Antonio Texas
United States Southwest Clinical Research Institute, LLC Tempe Arizona

Sponsors (1)

Lead Sponsor Collaborator
La Jolla Pharmaceutical Company

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Primary Determine the safety and tolerability of extended dosing with a fixed dose of GCS-100 3 mg IV push in patients with CKD (side effects) Evaluate side effects of this therapy when administered for an extended period of time. Determine response to therapy (by measuring kidney function monthly) as compared to subjects' response in study GCS-100-CS-4003. To determine if there are changes in markers (chemicals in the blood) in the blood shown to be related to disease state. Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period Yes
See also
  Status Clinical Trial Phase
Completed NCT05491642 - A Study in Male and Female Participants (After Menopause) With Mild to Moderate High Blood Pressure to Learn How Safe the Study Treatment BAY3283142 is, How it Affects the Body and How it Moves Into, Through and Out of the Body After Taking Single and Multiple Doses Phase 1
Recruiting NCT06363097 - Urinary Uromodulin, Dietary Sodium Intake and Ambulatory Blood Pressure in Patients With Chronic Kidney Disease
Terminated NCT04043026 - The Effects of Renal Function and Atrial Fibrillation on Lipoproteins and Clot Structure/Function
Completed NCT05318014 - Low-protein Formula Supplements in Chronic Kidney Disease N/A
Active, not recruiting NCT06071065 - Clinical Pharmacist Intervention on Medication Adherence and Clinical Outcomes in Chronic Kidney Disease Patients N/A
Completed NCT02878317 - Skin Autofluorescence as a Risk Marker in People Receiving Dialysis.
Not yet recruiting NCT06039254 - Safety and Pharmacokinetics of HRS-1780 in Healthy Subjects and Subjects With Impaired Renal Function Phase 1
Recruiting NCT03160326 - The QUALITY Vets Project: Muscle Quality and Kidney Disease
Completed NCT02888171 - Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency N/A
Completed NCT02756520 - Observational Study on CKD Treatment With a Ketosteril Supplemented Protein-restricted Diet (Keto-024-CNI)
Completed NCT02875886 - DD-study: Diet or Diuretics for Salt-sensitivity in Chronic Kidney Disease Phase 4
Withdrawn NCT02885545 - The Strategy to Prevent Hemorrhage Associated With Anticoagulation in Renal Disease Management (STOP HARM) Trial Phase 4
Completed NCT02836574 - A Study of Renal Autologous Cell Therapy (REACT) in Type 2 Diabetics With Chronic Kidney Disease Phase 2
Completed NCT02896309 - The Effect of Correction of Metabolic Acidosis in CKD on Intrarenal RAS Activity N/A
Active, not recruiting NCT02483039 - Nephrologist Follow-up Versus Usual Care After an Acute Kidney Injury Hospitalization N/A
Terminated NCT02543177 - Optimised Procedure in Patients With NSTEMI and CKD N/A
Completed NCT02992548 - Effect of Pravastatin on Erythrocyte Membrane Fatty Acid Contents in Patients With Chronic Kidney Disease Phase 4
Completed NCT02369549 - Micro-Particle Curcumin for the Treatment of Chronic Kidney Disease Phase 3
Recruiting NCT02205944 - Impact of Presurgical Exercise on Hemodialysis Fistula Outcomes N/A
Active, not recruiting NCT02231138 - Efficacy and Safety of Abelmoschus Manihot for Chronic Kidney Disease Phase 4