A Phase 2b Study of GCS-100 in Patients With Chronic Kidney Disease Caused by Diabetes

NCT02312050 | Unknown Phase 2

• 1 other identifier: LJ100-CKD04
• Study Type: interventional
• Target: 375
• Locations: 1 country
• Sites: 8

Brief 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. 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).

Conditions

Diabetic Chronic Kidney Disease

Outcome Measures

Primary Outcomes (1)

• The change in eGFR from Screening to measurements taken at Week 26

  26 weeks

Secondary Outcomes (4)

• Change in eGFR (as a scored value using 20% cut point) from Screening to Week 26

  26 weeks

• Change in eGFR (as a scored value using 30% cut point) from Screening to Week 26

  26 weeks

• Incidence of renal replacement therapy (RRT)

  26 weeks

• Incidence of major cardiac events

  26 weeks

Study Arms (4)

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

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

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

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

Drug: Placebo

Interventions

GCS-100 DRUG

1 mg, 3 mg, or 9 mg IV push injections

GCS-100 1 mg; GCS-100 3 mg; GCS-100 9 mg

Placebo DRUG

Normal Saline Solution 0.9%

Eligibility Criteria

• Age: 18 Years - 90 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• 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.

Sponsors & Collaborators

• La Jolla Pharmaceutical Company: lead

Study Sites (8)

Balboa Nephrology Medical Group

Chula Vista, California, 91910, United States

Location

Balboa Nephrology Medical Group

El Centro, California, 92243, United States

Location

Balboa Nephrology Medical Group

La Jolla, California, 92037, United States

Location

California Institute for Renal Research

La Mesa, California, 91942, United States

Location

Denver Nephrology

Denver, Colorado, 80230, United States

Location

Mountain Kidney & Hypertension

Asheville, North Carolina, 28801, United States

Location

Southeast Renal Research Institute

Chattanooga, Tennessee, 37408, United States

Location

Clinical Advancement Center

San Antonio, Texas, 78215, United States

Location

MeSH Terms

Interventions

GCS-100

Study Officials

• George F Tidmarsh, MD, PhD

  La Jolla Pharmaceutical Company

  STUDY DIRECTOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 5, 2014
• First Posted: December 9, 2014
• Study Start: March 1, 2015
• Primary Completion: September 1, 2016
• Study Completion: December 1, 2016
• Last Updated: May 19, 2015

Record last verified: 2015-05

Locations

US (8)