Chronic Kidney DiseasePhase 2NCT02155673
A Phase 2 Extension Study of Study GCS-100-CS-4002
A Phase 2 study testing GCS-100 in people with Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 5 sites in United States.
Trial summary
The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD. Read more about this study
- Who is it for?
- Ages 18 to 80 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
- 92 participants
- Where
- 5 sitesUnited States
- Study dates
- Jan 2014to Jun 2016
- Phase
- Phase 2
- 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 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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
Who cannot join
- 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
Trial locations and contacts
5 sites in 1 country.
5 sites in 1 country
United States5 sites
Mountain Kidney and Hypertension Associates, PA
Asheville, North Carolina, 28801
Denver Nephrology
Denver, Colorado, 80230
California Institute of Renal Research
La Mesa, California, 91942
Clinical Advancement Center, PLLC
San Antonio, Texas, 78215
Southwest Clinical Research Institute, LLC
Tempe, Arizona, 85284
About this study
The primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.
Read the detailed description
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.
- 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
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.
| Study group | Role | What they receive |
|---|---|---|
| Low Dose GCS-100 | Experimental | Low dose of GCS-100 Receives: Drug: GCS-100 |
| High Dose GCS-100 | Experimental | GCS-100 High dose Receives: Drug: GCS-100 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Evaluation of Safety
Evaluation of safety measures for long-term dosing including collection of adverse events in clinically significant changes in lab values
Measured: Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Jun 2014 (estimated)
- Study startJan 2014
- Primary completionMay 2016
- Study completionJun 2016
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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind
- Who is masked
- Participant
- Enrolment
- 92 participants (actual)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George Tidmarsh, MD, PhD, Study director
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02155673
- Sponsor's protocol ID
- GCS-100-CS-4003
- Status last verified
- Dec 2016
- First submitted
- 9 Apr 2014
- Last updated
- 26 Dec 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Dec 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2 Extension Study of Study GCS-100-CS-4002
- ClinicalTrials.gov ID
- NCT02155673
- Acronym / sponsor ID
- GCS-100-CS-4003
- Conditions
- Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 92 participants (actual)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Jan 2014
- Primary completion
- May 2016 (actual)
- Study completion
- Jun 2016 (actual)
- First posted
- 4 Jun 2014 (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 primary objective of this study is to determine the safety and tolerability of extended dosing of GCS-100 in patients with CKD.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (participant)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Low Dose GCS-100 | Experimental | Drug: GCS-100Low dose of GCS-100 |
| High Dose GCS-100 | Experimental | Drug: GCS-100GCS-100 High dose |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (2 listed)
- 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
Key exclusion criteria (8 listed)
- 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:
- 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
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-1001.5 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. | Drug | High Dose GCS-100, Low Dose GCS-100 |
Primary outcome
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
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 26 Dec 2016.
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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.
George Tidmarsh, MD, PhD study director
5 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing GCS-100 in people with Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 5 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 2 inclusion and 8 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 26 Dec 2016. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 5 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 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
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: Participants will be followed for the duration of the study, up to 1 year with a four week additional follow-up period.). 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 26 Dec 2016.