Is NCT07778667 recruiting in Oakland, CA?

Yes, NCT07778667 is currently enrolling participants at its Oakland, CA location. This fabry disease clinical trial is accepting qualified participants.

How do I join the fabry disease clinical trial in Oakland?

To join this clinical trial in Oakland, complete the eligibility form on this page. A study coordinator will contact you to discuss next steps and determine if you qualify.

Is participation in this Oakland clinical trial free?

Yes, all study-related care is provided at no cost to qualified participants. Many studies also offer compensation for time and travel expenses.

Fabry Disease Clinical Trial in Oakland, CA: Lucerastat (Phase 3)

About This Fabry Disease Study in Oakland

The purpose of this clinical trial is to learn how well lucerastat works and how safe it is in untreated adult male participants with Fabry disease. The main question this clinical trial aims to answer is: • Does treatment with lucerastat affects the amount of globotriaosylceramide (Gb3), a fatty substance that builds up in the kidneys, in untreated adult men with Fabry disease? This is an open-label, single-arm trial, which means that participants will know which trial medication they receive and only one trial medication will be given. Trial participants will: * Take lucerastat every day for 18 months * Have kidney biopsies at the end and start of the trial * Visit the clinic 10 times for check-up and tests * Take part in the trial for up to 21 months in total

Sponsor: Idorsia Pharmaceuticals Ltd.

Who Can Participate

Inclusion Criteria

Confirmed diagnosis of Fabry disease:

Plasma and/or leukocyte α-galactosidase A (α-GalA) \< 1% mean normal levels or

Known "pathogenic" or "likely pathogenic" Gene coding for α-galactosidase A (GLA) variant with a low level (i.e., \< 30% mean normal levels) of plasma and/or leukocyte α-GalA.

History of at least one of the following clinical manifestations of Fabry disease:

Neuropathic pain

Cornea verticillata

Angiokeratoma

Treatment-naïve or pseudo-naïve, i.e., without treatment with an approved therapy or any investigational therapy for Fabry disease for at least 6 months prior to screening. Applicable only to United Kingdom: Potential participants must have been informed of the availability of licensed treatment options for FD and that lucerastat is an unapproved investigational medicinal product that has not yet been assessed by any regulatory authority and determined to have a benefit-risk balance sufficient to support marketing authorization.

Plasma globotriaosylsphingosine ≥ 20 ng/ml (as assessed centrally).

Screening eGFR (central laboratory) ≥ 45 mL/min/1.73 m2.

Exclusion Criteria

Any intercurrent condition or concomitant therapy considered a contraindication for kidney biopsy, as per local standard of care, or in the investigator's opinion may preclude accurate interpretation of trial data.

Urine albumin-to-creatinine ratio \> 300 mg/g at screening (central laboratory) unless treated with background therapy, such as Angiotensin-converting enzyme inhibitors, Angiotensin receptor blocker or Sodium-glucose cotransporter 2 inhibitors, as per local practice.

Inherited or acquired coagulopathy, uncorrected bleeding disorders, international normalized ratio \> 1.5, platelet count \< 50,000/μL or inability to safely hold anticoagulants or antiplatelet therapy as applicable per local practice (usually 1-2 days for anticoagulants and 3-7 days for antiplatelets).

Hemoglobin level \< 9.0 g/dL at screening.

History of acute kidney injury within 12 months prior to screening visit.

Documented poorly controlled diabetes mellitus (i.e., Hemoglobin A1c \> 8.0% at screening as reported by the central laboratory).

History of cerebrovascular event (e.g. stroke, transient ischemic attack), cardiovascular event (e.g., myocardial infarction, unstable angina), cardiac surgery (e.g., coronary artery bypass graft, valvular repair/replacement) or percutaneous coronary intervention within 6 months prior to screening.

Congestive heart failure New York Heart Association class IV or hospitalization for heart failure within 3 months prior to screening.

Implementation of cardiac device (e.g., pacemaker, implantable cardioverter defibrillator, cardiac resynchronization therapy device) or hospitalization for arrhythmia within 6 weeks prior to screening.

Any other known factor or disease that might interfere with treatment compliance, trial conduct, or interpretation of the results, such as drug or alcohol dependence or psychiatric disease including: Applicable only to Canada and United Kingdom: severe depression or suicidal ideation at screening or history of suicide attempt or behavior within 6 months prior to screening visit. Applicable only to Europe and United States: Any of the following:

moderate depression (defined as BDI-II score \> 20 and ≤ 28) if the participant does not agree to a consultation before Visit 2 with an appropriately qualified mental health professional or

severe depression (i.e., Beck Depression Inventory-II \[BDI-II\] score \> 28) or

suicidal ideation at screening or history of suicide attempt or behavior within 12 months prior to screening visit.

Previous exposure to gene or cell therapy.

Use of cationic amphiphilic drugs, such as amiodarone or hydroxychloroquine that may preclude accurate interpretation of kidney biopsy data within 6 months prior to screening.

Not sure if you qualify? Submit your interest and a study coordinator will help determine your eligibility.

Frequently Asked Questions

Q:Is this study available in Oakland?

Yes, this clinical trial (NCT07778667) has an active research site in Oakland, CA that is currently enrolling participants.

Q:Is it safe to participate?

Clinical trials follow strict safety guidelines and ethical standards. This study has been reviewed and approved, and participants are closely monitored by medical professionals. You can withdraw at any time.

Q:Will I be compensated?

Many clinical trials offer compensation for your time and travel expenses. Specific compensation details will be discussed during the screening process. All study-related medical care is provided at no cost.

Q:Can I leave the trial if I change my mind?

Absolutely. Participation is completely voluntary. You have the right to withdraw from the study at any time, for any reason, without penalty.

Still have questions? Our study coordinators are here to help.

Fabry Disease Treatment Options in Oakland, CA

If you're searching for fabry disease treatment options in Oakland, CA, this clinical trial (NCT07778667) may be an excellent opportunity. Clinical trials provide access to cutting-edge treatments that aren't yet available to the general public, often at no cost to participants.

Our Oakland research site is actively enrolling participants for this phase 3 clinical trial. You'll receive care from experienced fabry disease specialists who are at the forefront of medical research. All study-related care, including examinations, treatments, and monitoring, is provided at no cost to qualified participants.

Looking for more options? Browse all fabry disease clinical trials near you to find additional studies recruiting in your area.

Fabry Disease Clinical Trial in Oakland, CA

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