FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)
A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)
1 other identifier
interventional
33
1 country
24
Brief Summary
This is a multicenter, open label, randomized study investigating two dose titration regimens of CXA-10 in subjects at least 18 years of age with primary FSGS. The study will be performed at approximately 25 study centers across the United States of America (USA). The recruitment period is anticipated to be up to approximately 16 months. Approximately 30 subjects will be randomized to ensure 26 subjects complete the study. An optional 9 month open label is available
Trial Health
Trial Health Score
Automated assessment based on enrollment pace, timeline, and geographic reach
participants targeted
Target at P25-P50 for phase_2
Started Apr 2018
24 active sites
Health score is calculated from publicly available data and should be used for screening purposes only.
Trial Relationships
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Study Timeline
Key milestones and dates
First Submitted
Initial submission to the registry
January 30, 2018
CompletedFirst Posted
Study publicly available on registry
February 5, 2018
CompletedStudy Start
First participant enrolled
April 15, 2018
CompletedPrimary Completion
Last participant's last visit for primary outcome
July 31, 2020
CompletedStudy Completion
Last participant's last visit for all outcomes
July 31, 2020
CompletedAugust 3, 2020
July 1, 2020
2.3 years
January 30, 2018
July 31, 2020
Conditions
Keywords
Outcome Measures
Primary Outcomes (1)
Reduction in proteinuria
overall reduction as measured by percent change from baseline
3 months
Secondary Outcomes (1)
The percent of subjects with of partial remission, modified partial remission, and complete remission
months 1, 2, 3
Study Arms (4)
Regimen 1 - CXA-10 75 mg
EXPERIMENTALSubjects in regimen 1 will start at 75 mg and may stay at 75 mg or increase to 150 mg. This treatment arm stays at 75 mg.
Regimen 1 - CXA-10 150 mg
EXPERIMENTALSubjects in regimen 1 will start at 75 mg and may stay at 75 mg or increase to 150 mg. This treatment arm increases to 150 mg.
Regimen 2 - CXA-10 150 mg
EXPERIMENTALSubjects in regimen 2 will start at 150 mg and may stay at 150 mg or increase to 300 mg. This treatment arm stays at 150 mg.
Regimen 2 - CXA-10 300 mg
EXPERIMENTALSubjects in regimen 2 will start at 150 mg and may stay at 150 mg or increase to 300 mg. This treatment arm increases to 300 mg.
Interventions
CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)
Eligibility Criteria
You may qualify if:
- have a diagnosis of primary FSGS confirmed with biopsy.
- eGFR or 24-hour creatinine clearance ≥ 40 mL/min/1.73 m2 at Screening.
- The subject has a Up/c ratio ≥ 2 g protein/g creatinine based on a 24 hour urine sample collected during Screening (one 24-hour collection between Day -30 and Day -8).
- Unless there is an allergy or intolerance, subject must be on an ACEi and/or ARB regimen for a minimum of 4 weeks prior to their screening Up/c assessment. The ACEi and/or ARB regimen must be stable for a minimum of 2 weeks prior to screening Up/c assessment (and there are no plans to change the ACEi/ARB regimen over the course of the study).
- If receiving simvastatin containing products: simvastatin (Zocor), Vytorin, or any other combination therapy containing simvastatin, the simvastatin dose should not exceed 20 mg/day.
- Non-pregnant, non-lactating, female of childbearing potential who agrees to use a reliable method of contraception or female is of non-childbearing potential defined as surgically sterile (hysterectomy or bilateral tubal ligation) or post-menopausal.
You may not qualify if:
- The subject has collapsing variant of FSGS on renal biopsy.
- The subject has secondary FSGS.
- The subject has diabetic nephropathy.
- The subject has any other form of acquired (including biopsy proven obesity-induced FSGS) or hereditary glomerular nephropathy.
- The subject has a prolonged QTcF interval.
- The subject is hypertensive.
- The subject has a history of clinically significant cardiovascular events, arrhythmias, recurrent fainting, palpitations, or family history of congenital prolonged QT syndromes or sudden unexpected death due to a cardiac reason.
- The subject has any known bleeding disorders or significant active peptic ulceration in the opinion of the investigator that precludes enrollment into this study.
- The subject has clinically significant anemia in the opinion of the investigator that precludes enrollment into this study.
- The subject has a history of any primary malignancy, including a history of melanoma or suspicious undiagnosed skin lesions, with the exception of the following:
- Basal cell or squamous cell carcinomas of the skin,
- Cervical carcinoma in situ,
- Other malignancies curatively treated and with no evidence of disease for at least 5 years, or
- Prostate cancer which is not currently or expected, during the study, to undergo radiation therapy, chemotherapy, and/or surgical intervention, or to initiate hormonal treatment.
- The subject has a history of organ transplantation.
- +19 more criteria
Contact the study team to confirm eligibility.
Sponsors & Collaborators
- Complexa, Inc.lead
- Kidney Research Network, formerly NephCure Accelerating Cures Institutecollaborator
- Medpace, Inc.collaborator
- MicroConstantscollaborator
- Arkana Labscollaborator
- NephCure Kidney Internationalcollaborator
Study Sites (24)
Alabama Neurology Consultants
Huntsville, Alabama, 35805, United States
Cedars Sinai Medical Center
Los Angeles, California, 90048-9978, United States
Stanford University
Palo Alto, California, 94304, United States
A.I. duPont Hospital for Children
Wilmington, Delaware, 19803, United States
University of Miami
Miami, Florida, 33136, United States
Nephrology Associates of Northern Illinois and Indiana (NANI)
Chicago, Illinois, 60521, United States
Northwest Louisiana Nephrology
Shreveport, Louisiana, 71101, United States
Kidney Care and Transplant Services of New England
Springfield, Massachusetts, 01107, United States
University of Michigan
Ann Arbor, Michigan, 48109, United States
St. Clair Nephrology Research
Roseville, Michigan, 48066, United States
Clinical Research Consultants-KCMO
Kansas City, Missouri, 64111, United States
Albert Einstein College of Medicine, Montefiore
The Bronx, New York, 10461, United States
Metrolina Nephrology Associates
Charlotte, North Carolina, 28204, United States
Levine Children's Hospital
Charlotte, North Carolina, 28207, United States
Cleveland Clinic
Cleveland, Ohio, 44195, United States
Northeast Clinical Research Center (NCRC)
Bethlehem, Pennsylvania, 18017, United States
University of Pennsylvania
Philadelphia, Pennsylvania, 19104, United States
Nephrology Associates
Franklin, Tennessee, 37205, United States
Texas Tech
Amarillo, Texas, 79106, United States
Renal Disease Research Institute
DeSoto, Texas, 75115, United States
El Paso Medical Research
El Paso, Texas, 79935, United States
Virginia Commonwealth University
Richmond, Virginia, 23298, United States
The Polyclinic
Seattle, Washington, 98104, United States
Providence Sacred Heart Medical Center and Children's Hospital
Spokane, Washington, 99204, United States
MeSH Terms
Conditions
Interventions
Condition Hierarchy (Ancestors)
Study Officials
- STUDY DIRECTOR
Theodore Danoff, MD
Complexa, Inc.
Study Design
- Study Type
- interventional
- Phase
- phase 2
- Allocation
- RANDOMIZED
- Masking
- NONE
- Purpose
- TREATMENT
- Intervention Model
- PARALLEL
- Sponsor Type
- INDUSTRY
- Responsible Party
- SPONSOR
Study Record Dates
First Submitted
January 30, 2018
First Posted
February 5, 2018
Study Start
April 15, 2018
Primary Completion
July 31, 2020
Study Completion
July 31, 2020
Last Updated
August 3, 2020
Record last verified: 2020-07