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The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| GCS-100 | Experimental | GCS-100 will be administered once weekly by a ten minutes injection. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GCS-100 | Drug | GCS-100 is a modified citrus pectin that binds to and sequesteres circulating galectin-3, a protein that has been shown to promote organ disease (fibrosis). |
|
| Measure | Description | Time Frame |
|---|---|---|
| Evaluation of Safety | Assess overall safety of rising dose of GCS-100 in CKD patients | Ongoing |
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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 is male or female, aged >=18 and <= 75. Patients older than 75 y/o will be included at the request of the investigator and at the discretion of the Medical Monitor .
3. Adult patients with chronic kidney disease for longer than 12 months and stable in the opinion of the investigator for the past 3 months 4. Systolic blood pressure <=160 mm Hg and >= 90 mm Hg on 2 readings. Diastolic blood pressure <= 100 mm Hg and >= 40 mm Hg on 2 readings during at least one of the screening visits.
5. Subject is willing to practice birth control. 6. Subject is willing and able to comply with all protocol requirements. 7. Subject has a measureable level of galectin-3 concentration in plasma at any time prior to entry.
8. Subject has a glomerular filtration rate between 15-45 mL/min/1.73 m2 determined using the CKD-EPI equation (see section 3.6.1) 9. Subject's has clinical laboratory values of:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Pablo Pergola, MD | Renal Associaties PA, Research Division | Principal Investigator |
| Geoffrey Block, MD | Denver Nephrologists, PC | Principal Investigator |
| Bhupinder Singh, MD | Southwest Clinical Research Institute, LLC | Principal Investigator |
| George Fadda, MD | California Institute of Renal Research | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Southwest Clinical Research Institute | Tempe | Arizona | 85284 | United States | ||
| California Institue of Renal Research |
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| ID | Term |
|---|---|
| D051436 | Renal Insufficiency, Chronic |
| ID | Term |
|---|---|
| D051437 | Renal Insufficiency |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
| D052776 | Female Urogenital Diseases |
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| ID | Term |
|---|---|
| C505531 | GCS-100 |
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| La Mesa |
| California |
| 91942 |
| United States |
| Denver Nephrologists, PC | Denver | Colorado | 80230 | United States |
| Renal Associates PA / Research Division | San Antonio | Texas | 78215 | United States |
| D005261 |
| Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D002908 | Chronic Disease |
| D020969 | Disease Attributes |
| D010335 | Pathologic Processes |
| D013568 | Pathological Conditions, Signs and Symptoms |