Diabetic Chronic Kidney DiseasePhase 2NCT02312050
A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
A Phase 2 study testing GCS-100 in people with Diabetic Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 8 sites in United States.
Trial summary
A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Read more about this study
- Who is it for?
- Ages 18 to 90 years
- Conditions the study is for
- Diabetic Chronic Kidney Disease
- What is being tested?
- GCS-100
- Type of treatment
- Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 375 participants
- Where
- 8 sitesUnited States
- Study dates
- Mar 2015to Dec 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patient is capable of understanding the purpose and risks of the study and is able to provide written informed consent.
- Patient is ≥ 18 and ≤ 90 years of age.
- Patient has a baseline eGFR of 15 to < 45 mL/min/1.73m2, defined as the average of 2 measurements collected at Screening Visits 1 and 2, and determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- Patients with diabetic CKD diagnosis > 12 months, and if requiring renin-angiotensin-aldosterone system (RAAS) blockade medications, must be receiving stable doses (i.e., not requiring modification) for the 3 months prior to first study drug dose.
- Stable eGFR as measured by a less than 25% variability of each Screening value from the average of the 2 Screening values taken no less than 5 days and no more than 10 days apart.
- Patient is willing and able to comply with all protocol requirements.
- Female patients of childbearing potential (i.e., women who have not been surgically sterilized or who have not been post-menopausal for at least 1 year) and male patients with partners of childbearing potential must agree to use medically acceptable methods of contraception throughout the study period.
Who cannot join
- Treatment with an experimental (unlicensed) drug within 4 weeks prior to Screening visit 1.
- Patients who are known to be allergic to citrus or have a history of any allergies associated with hypersensitivity to citrus.
- Patients who have begun new treatment with angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor blockers (MRBs), or direct renin inhibitors (DRIs) within the 3 months prior to first dose.
- Kidney disease known to be due to causes other than diabetes.
- Patients diagnosed with acute kidney injury (AKI) within the 3 months prior to first dose.
- Planned renal replacement therapy of any kind within 6 months of first study drug dose.
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- Previous solid organ transplant.
- Evidence of persistent, uncontrolled hypertension, i.e., systolic blood pressure ≥ 160 mmHg and diastolic blood pressure ≥ 100 mmHg; or evidence of persistent, uncontrolled hypotension, i.e., systolic blood pressure ≤ 90 mmHg and diastolic blood pressure ≤ 40 mmHg at repeated measures during Screening.
- Patients who have Screening 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
- HbA1c > 10.5%
- Concomitant treatment with immunosuppressive agents, except for stable use of topical agents or inhaled steroids.
- Patients who have previously received GCS-100 as part of another clinical trial.
- Known history of cancer (excluding non-melanoma skin cancer that is not being actively treated) within 5 years of Screening.
- Known history of human immunodeficiency virus, active hepatitis C virus (HCV), active hepatitis B virus (HBV), or prior history of infection with HBV (HBcAb positive); if adequate hepatic function has been documented for patients with HCV or prior history of hepatitis B without evidence of cirrhosis, the Medical Monitor may approve their enrollment.
- 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, severe or uncontrolled chronic obstructive or chronic restrictive pulmonary disease, and/or cirrhosis.
- Patient had major surgery within 12 weeks of first study drug dose.
- If female, patient is pregnant or breastfeeding.
- Patient 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 patient at unacceptable risk.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
United States8 sites
Mountain Kidney & Hypertension
Asheville, North Carolina, 28801
Southeast Renal Research Institute
Chattanooga, Tennessee, 37408
Balboa Nephrology Medical Group
Chula Vista, California, 91910
Denver Nephrology
Denver, Colorado, 80230
Balboa Nephrology Medical Group
El Centro, California, 92243
Balboa Nephrology Medical Group
La Jolla, California, 92037
California Institute for Renal Research
La Mesa, California, 91942
Clinical Advancement Center
San Antonio, Texas, 78215
About this study
Official title: A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).
Read the detailed 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 caused by diabetes.
- Conditions
- Diabetic Chronic Kidney Disease
- Being tested
- GCS-100, Placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
GCS-100Drug
1 mg, 3 mg, or 9 mg IV push injections
PlaceboDrug
| Study group | Role | What they receive |
|---|---|---|
| GCS-100 1 mg | Experimental | Dose level 1 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months Receives: Drug: GCS-100 |
| GCS-100 3 mg | Experimental | Dose level 2 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months Receives: Drug: GCS-100 |
| GCS-100 9 mg | Experimental | Dose level 3 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months Receives: Drug: GCS-100 |
| Normal Saline Solution 0.9% | Placebo comparator | Placebo - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
The change in eGFR from Screening to measurements taken at Week 26
Measured: 26 weeks
Secondary outcomes (4)
Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26
Measured: 26 weeks
Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26
Measured: 26 weeks
Incidence of renal replacement therapy (RRT)
Measured: 26 weeks
Incidence of major cardiac events
Measured: 26 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Dec 2014 (estimated)
- Study startMar 2015
- Primary completionSep 2016 (estimated)
- Study completionDec 2016 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Diabetic 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
- Single group
- Masking
- Triple blind
- Who is masked
- Participant, Investigator, Outcomes assessor
- Enrolment
- 375 participants (estimated)
Sponsor and investigators
- Lead sponsor
- La Jolla Pharmaceutical Company
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- George F Tidmarsh, MD, PhD, Study director, La Jolla Pharmaceutical Company
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02312050
- Sponsor's protocol ID
- LJ100-CKD04
- Status last verified
- May 2015
- First submitted
- 5 Dec 2014
- Last updated
- 19 May 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 May 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Phase 2b, Placebo-Controlled, Randomized, Double-Blind, Multi-Center Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes
- ClinicalTrials.gov ID
- NCT02312050
- Acronym / sponsor ID
- LJ100-CKD04
- Conditions
- Diabetic Chronic Kidney Disease
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 375 participants (estimated)
- Lead sponsor
- La Jolla Pharmaceutical CompanyIndustry (pharma, biotech, devices)
- Study start
- Mar 2015
- Primary completion
- Sep 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 9 Dec 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.
A phase 2b, placebo-controlled, randomized, double-blind, multi-center study of GCS-100 in patients with chronic kidney disease caused by diabetes. The study will enroll approximately 375 patients at multiple centers located in the United States. Study duration is 6 months. Patients will be randomly assigned 1:1:1:1 to treatment with placebo (0.9% Sodium Chloride Injection, USP), 1 mg, 3 mg, or 9 mg GCS-100. All doses of study drug will be administered via intravenous (IV) push injection once weekly for 2 months (8 weeks), then every other week for an additional 4 months (16 weeks).
Detailed 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 caused by diabetes.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Single group
- Masking
- Triple blind (participant, investigator, outcomes assessor)
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| GCS-100 1 mg | Experimental | Drug: GCS-100Dose level 1 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months |
| GCS-100 3 mg | Experimental | Drug: GCS-100Dose level 2 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months |
| GCS-100 9 mg | Experimental | Drug: GCS-100Dose level 3 - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months |
| Normal Saline Solution 0.9% | Placebo comparator | Drug: PlaceboPlacebo - administered via IV push injection weekly for 2 months, then every other week for an additional 4 months |
Who may qualify
- Ages
- 18 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Patient is capable of understanding the purpose and risks of the study and is able to provide written informed consent.
- Patient is ≥ 18 and ≤ 90 years of age.
- Patient has a baseline eGFR of 15 to < 45 mL/min/1.73m2, defined as the average of 2 measurements collected at Screening Visits 1 and 2, and determined using the 4-variable Modification of Diet in Renal Disease (MDRD) equation.
- Patients with diabetic CKD diagnosis > 12 months, and if requiring renin-angiotensin-aldosterone system (RAAS) blockade medications, must be receiving stable doses (i.e., not requiring modification) for the 3 months prior to first study drug dose.
- Stable eGFR as measured by a less than 25% variability of each Screening value from the average of the 2 Screening values taken no less than 5 days and no more than 10 days apart.
Key exclusion criteria (21 listed)
- Treatment with an experimental (unlicensed) drug within 4 weeks prior to Screening visit 1.
- Patients who are known to be allergic to citrus or have a history of any allergies associated with hypersensitivity to citrus.
- Patients who have begun new treatment with angiotensin converting enzyme inhibitors (ACEIs), angiotensin receptor blockers (ARBs), mineralocorticoid receptor blockers (MRBs), or direct renin inhibitors (DRIs) within the 3 months prior to first dose.
- Kidney disease known to be due to causes other than diabetes.
- Patients diagnosed with acute kidney injury (AKI) within the 3 months prior to first dose.
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 mg, 3 mg, or 9 mg IV push injections | Drug | GCS-100 1 mg, GCS-100 3 mg, GCS-100 9 mg |
| Placebo | Drug | Normal Saline Solution 0.9% |
Primary outcome
The change in eGFR from Screening to measurements taken at Week 26
Time frame: 26 weeks
4 secondary outcomes
Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26
Time frame: 26 weeks
Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26
Time frame: 26 weeks
Incidence of renal replacement therapy (RRT)
Time frame: 26 weeks
Incidence of major cardiac events
Time frame: 26 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 May 2015.
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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 F Tidmarsh, MD, PhD study director
La Jolla Pharmaceutical Company
8 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 Diabetic Chronic Kidney Disease, run by La Jolla Pharmaceutical Company at 8 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 7 inclusion and 21 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: status not confirmed, as of the sponsor's last update on 19 May 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 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. Some participants in this study may receive a placebo. 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?
Results are not available in the source record.
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?
The change in eGFR from Screening to measurements taken at Week 26 (time frame: 26 weeks). 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 19 May 2015.