Chronic Kidney DiseasePhase 1NCT01717248
Safety Study of GCS-100 to Treat Chronic Kidney Disease
A Phase 1 study testing GCS-100 in people with Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 4 sites in United States.
Trial summary
The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Chronic Kidney Disease
- What is being tested?
- GCS-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 29 participants
- Where
- 4 sitesUnited States
- Study dates
- Jan 2013to Jun 2013
- Phase
- Phase 1
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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:
- Hemoglobin ≥9 g/dL
- Total bilirubin ≤ 1.5 X Institutional Upper Limit of Normal (IULN)
- AST and/or ALT ≤ 2.5 X the upper limit of normal 10. Female subjects of childbearing potential (i.e., women who have not been surgically sterilized or have not been post-menopausal for at least 1 year) and male subjects with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period.
Who cannot join
- Subjects who have had treatment with an experimental (unlicensed) drug within 4 weeks or ≤ 5 half-lives prior to treatment with GCS 100.
- Subjects with kidney disease due to systemic lupus erythematosus (regardless of whether active or in remission), any form of vasculitis (regardless of whether active or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease, untreated obstructed nephropathy or any other causes that in the opinion of the investigator may put the subject at an increased risk
- Subject is expected to start renal replacement therapy of any kind within 6 months after enrollment
- Subjects with previous solid organ transplant
- Subject is undergoing treatment with immunosuppression agents except for topical agents or inhaled steroids when conditions are chronic and stable.
- Subject with know history of cancer within the past 5 years prior to enrollment excluding non-melanoma skin cancer that is not being actively treated
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- Subject has a known history of human immunodeficiency virus infection, active hepatitis C, active hepatitis B, or prior history of infection with hepatitis B (HBcAb positive). Medical Monitor may approve if adequate hepatic function has been documented for patients without evidence of cirrhosis for subjects with HCV or prior history of hepatitis B, including, but not limited to liver biopsy.
- Subject has a clinically relevant active infection and/or a serious co-morbid medical condition such as recent myocardial infarction (within the last 6 months), unstable angina, difficult-to-control congestive heart failure, uncontrolled hypertension, difficult-to-control cardiac arrhythmias, chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
- Subject had major surgery within 4 weeks prior to Study Day 1.
- If female, subject is pregnant or breastfeeding.
- 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 could put the subject at unacceptable risk.
Trial locations and contacts
4 sites in 1 country.
United States4 sites
Denver Nephrologists, PC
Denver, Colorado, 80230
California Institue of Renal Research
La Mesa, California, 91942
Renal Associates PA / Research Division
San Antonio, Texas, 78215
Southwest Clinical Research Institute
Tempe, Arizona, 85284
About this study
Official title: A Phase 1 Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease
The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease.
- Conditions
- Chronic Kidney Disease
- Being tested
- GCS-100
- Medical subject headings
- Renal Insufficiency, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCS-100Drug
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).
| Study group | Role | What they receive |
|---|---|---|
| GCS-100 | Experimental | GCS-100 will be administered once weekly by a ten minutes injection. Receives: Drug: GCS-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Assess overall safety of rising dose of GCS-100 in CKD patients
Measured: Ongoing
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Oct 2012 (estimated)
- Study startJan 2013
- Primary completionJun 2013
- Study completionJun 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Chronic Kidney DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 1
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 29 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Pablo Pergola, MD, Principal investigator, Renal Associaties PA, Research DivisionGeoffrey Block, MD, Principal investigator, Denver Nephrologists, PCBhupinder Singh, MD, Principal investigator, Southwest Clinical Research Institute, LLCGeorge Fadda, MD, Principal investigator, California Institute of Renal Research
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01717248
- Sponsor's protocol ID
- GCS-100-CS-4001
- Status last verified
- Jun 2013
- First submitted
- 26 Oct 2012
- Last updated
- 20 Jun 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 20 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 1 Study of Weekly Doses of GCS-100 in Patients With Chronic Kidney Disease
- ClinicalTrials.gov ID
- NCT01717248
- Acronym / sponsor ID
- GCS-100-CS-4001
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 1
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 29 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2013
- Primary completion
- Jun 2013 (actual)
- Study completion
- Jun 2013 (actual)
- First posted
- 30 Oct 2012 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The purpose of this study is to evaluate the safety of GCS-100 as a treatment for chronic kidney disease.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| GCS-100 | Experimental | Drug: GCS-100GCS-100 will be administered once weekly by a ten minutes injection. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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:
Key exclusion criteria (11 listed)
- Subjects who have had treatment with an experimental (unlicensed) drug within 4 weeks or ≤ 5 half-lives prior to treatment with GCS 100.
- Subjects with kidney disease due to systemic lupus erythematosus (regardless of whether active or in remission), any form of vasculitis (regardless of whether active or in remission), IgA nephropathy, multiple myeloma, polycystic kidney disease, untreated obstructed nephropathy or any other causes that in the opinion of the investigator may put the subject at an increased risk
- Subject is expected to start renal replacement therapy of any kind within 6 months after enrollment
- Subjects with previous solid organ transplant
- Subject is undergoing treatment with immunosuppression agents except for topical agents or inhaled steroids when conditions are chronic and stable.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| GCS-100GCS-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). | Drug | GCS-100 |
Primary outcome
Evaluation of Safety
Time frame: Ongoing
Assess overall safety of rising dose of GCS-100 in CKD patients
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 20 Jun 2013.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Pablo Pergola, MD principal investigator
Renal Associaties PA, Research Division
Geoffrey Block, MD principal investigator
Denver Nephrologists, PC
Bhupinder Singh, MD principal investigator
Southwest Clinical Research Institute, LLC
4 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 1 study testing GCS-100 in people with Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 4 sites in United States.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 11 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 20 Jun 2013. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 4 sites in United States. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 1 studies test a treatment in a small group of people for the first time or in a new way, mainly to check safety and find the right dose.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Evaluation of Safety (time frame: Ongoing). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 20 Jun 2013.