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Primary Focal Segmental GlomerulosclerosisPhase 2NCT03422510

FIRSTx - A Study of Oral CXA-10 in Primary Focal Segmental Glomerulosclerosis (FSGS)

A Phase 2 study testing CXA-10 in people with Primary Focal Segmental Glomerulosclerosis, run by Complexa, Inc. at 24 sites in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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). Read more about this study

Who is it for?
Ages 13 years and older
What is being tested?
CXA-10
Could I receive a placebo?
No, everyone receives an active treatment
How many people
33 participants
Where
24 sitesUnited States
Study dates
15 Apr 2018to 31 Jul 2020
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 13 years and older
  • All sexes
  • No healthy volunteers
  • Child, Adult, Older adult

Who may be able to join

  • 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.

Who cannot join

  • 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.
Show all 34Show fewer
  • 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.
  • The subject has a history of HIV.
  • At the time of Screening (Visit 1), the subject has any co-existing disease or condition.
  • Since the time of presentation of symptoms/diagnosis of FSGS: the subject has received systemic (oral or parenteral) high-dose, long-term corticosteroid therapy (prednisone or alternative glucocorticoid) to treat kidney disease
  • Subject has a history of immunosuppressant therapy (calcineurin inhibitors, rituximab, or other non-steroid immunosuppressants).
  • The subject has a history of herbal or natural medication use (including fish oil) within 2 weeks or 5 half-lives, whichever is longer, prior to Baseline
  • The subject is currently taking a drug that may affect the measurement of serum creatinine (e.g. cimetidine, Bactrim, Pyridium).
  • The subject is currently taking a newly prescribed drug or new prescription for an increased dose of an existing drug that is known to prolong the QTc interval and has been associated with Torsades de pointes (a list is provided in Appendix H). Note: Stable doses of these drugs are permitted (i.e., subject has received the same dose and regimen for at least 30 days prior to Screening [Visit 1] with no anticipated changes to the dose or regimen during the study).
  • The subject is currently taking endothelin receptor antagonists, dimethyl fumarate (Tecfidera™), orlistat, fibrates (fenofibrate, bezafibrate, gemfibrozil and ciprofibrate), niacin or lomatapide.
  • The subject has any of the following abnormal laboratories at Screening:
  • Serologic evidence of HIV, hepatitis B, or hepatitis C based on HIV antibody, HBsAg, and HCV Ab,
  • Absolute lymphocyte counts below the lower limit of normal of the reference range
  • Aspartate aminotransferase (AST) and/or alanine aminotransferase (ALT) > 3.0X upper limit of normal (ULN), alkaline phosphatase > 2X ULN of liver origin, and total bilirubin >2X ULN. If all LFTs are within normal limits (WNL) and total bilirubin is elevated, examination of direct and indirect bilirubin may be conducted to evaluate for Rotor's/Gilbert's Syndrome. Subjects with Rotor's/Gilbert's Syndrome may be enrolled.
  • Female subject with a positive urine beta-human chorionic gonadotropin (β-hCG) test at Screening (Visit 1) (all females) or Baseline (Visit 2) (females of childbearing potential or with a history of bilateral tubal ligation in the absence of documented menopause).
  • The subject has received a live attenuated vaccine within 6 weeks prior to Baseline (Visit 2) or plans to receive a live attenuated vaccine during the study period.
  • The subject has a recent history (within one year prior to Screening [Visit 1]) of abusing alcohol or illicit drugs (including marijuana) or history of extensive illicit intravenous drug use.
  • Any other condition and/or situation that causes the Investigator to deem a subject unsuitable for the study (e.g., due to expected study medication non-compliance, inability to medically tolerate the study procedures, or a subject's unwillingness to comply with study-related procedures).
  • The subject has known hypersensitivity to CXA-10, its metabolites, or formulation excipients.
  • The subject has had treatment with any investigational drug or device within 30 days or 5 half-lives (whichever is longer) prior to Screening (Visit 1) (this includes investigational formulations of marketed products, inhaled and topical drugs), or plans to participate in another investigational drug or device study at any time during this study.
  • The subject weighs < 40 kg

Trial locations and contacts

24 sites in 1 country.

24 sites in 1 country

United States24 sites

  • Texas Tech

    Amarillo, Texas, 79106

  • University of Michigan

    Ann Arbor, Michigan, 48109

  • Northeast Clinical Research Center (NCRC)

    Bethlehem, Pennsylvania, 18017

  • Metrolina Nephrology Associates

    Charlotte, North Carolina, 28204

  • Levine Children's Hospital

    Charlotte, North Carolina, 28207

  • Nephrology Associates of Northern Illinois and Indiana (NANI)

    Chicago, Illinois, 60521

  • Cleveland Clinic

    Cleveland, Ohio, 44195

  • Renal Disease Research Institute

    DeSoto, Texas, 75115

  • El Paso Medical Research

    El Paso, Texas, 79935

  • Nephrology Associates

    Franklin, Tennessee, 37205

  • Alabama Neurology Consultants

    Huntsville, Alabama, 35805

  • Clinical Research Consultants-KCMO

    Kansas City, Missouri, 64111

  • Cedars Sinai Medical Center

    Los Angeles, California, 90048-9978

  • University of Miami

    Miami, Florida, 33136

  • Stanford University

    Palo Alto, California, 94304

  • University of Pennsylvania

    Philadelphia, Pennsylvania, 19104

  • Virginia Commonwealth University

    Richmond, Virginia, 23298

  • St. Clair Nephrology Research

    Roseville, Michigan, 48066

  • The Polyclinic

    Seattle, Washington, 98104

  • Northwest Louisiana Nephrology

    Shreveport, Louisiana, 71101

  • Providence Sacred Heart Medical Center and Children's Hospital

    Spokane, Washington, 99204

  • Kidney Care and Transplant Services of New England

    Springfield, Massachusetts, 01107

  • Albert Einstein College of Medicine, Montefiore

    The Bronx, New York, 10461

  • A.I. duPont Hospital for Children

    Wilmington, Delaware, 19803

Other trials in United States

About this study

Official title: A Phase 2 Multicenter, Open Label, Randomized Study of Two Titration Regimens of Oral CXA-10 in Subjects With Primary Focal Segmental Glomerulosclerosis (FSGS)

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

Read the detailed description

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.

Study participation for each subject will last up to 5 months. The study will consist of a screening period not to exceed 30 days (1 month), 90-day (3 month) treatment period, and an approximate 28-day (1 month) follow-up period after the last dose of study medication. An optional 9 month open label is available.

Being tested
CXA-10
Keywords
FSGS, Kidney Disease, Proteinuria, Nephrotic Syndrome, FIRSTx, Nitro fatty acids, OA-NO2, 10-nitro oleic acid, Nitro oleic acid
Medical subject headings
Kidney Diseases, Proteinuria, Nephrotic Syndrome

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • CXA-10Drug

    CXA-10 (10-nitro-9(E)-octadec-9-enoic acid) is a specific isomer of nitro-oleic acid (OA-NO2)

Study groups in NCT03422510
Study groupRoleWhat they receive
Regimen 1 - CXA-10 75 mgExperimentalSubjects 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.
Receives: Drug: CXA-10
Regimen 1 - CXA-10 150 mgExperimentalSubjects 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.
Receives: Drug: CXA-10
Regimen 2 - CXA-10 150 mgExperimentalSubjects 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.
Receives: Drug: CXA-10
Regimen 2 - CXA-10 300 mgExperimentalSubjects 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.
Receives: Drug: CXA-10

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. Reduction in proteinuria

    overall reduction as measured by percent change from baseline

    Measured: 3 months

Secondary outcomes (1)

  1. The percent of subjects with of partial remission, modified partial remission, and complete remission

    percent change from baseline

    Measured: months 1, 2, 3

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted5 Feb 2018
  2. Study start15 Apr 2018
  3. Primary completion31 Jul 2020
  4. Study completion31 Jul 2020

Resources

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
None (open label)
Enrolment
33 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT03422510
Sponsor's protocol ID
CXA-10-204
Status last verified
Jul 2020
First submitted
30 Jan 2018
Last updated
3 Aug 2020
Results posted
No
Data monitoring committee
No
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Undecided

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing CXA-10 in people with Primary Focal Segmental Glomerulosclerosis, run by Complexa, Inc. at 24 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 6 inclusion and 34 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 3 Aug 2020. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 24 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?

Reduction in proteinuria (time frame: 3 months). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT03422510.

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 3 Aug 2020.

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