Is NCT06476132 recruiting in Los Angeles, CA?

Yes, NCT06476132 is currently recruiting participants at its Los Angeles, CA location. This lung transplant clinical trial is actively enrolling qualified participants.

How do I join the lung transplant clinical trial in Los Angeles?

To join this clinical trial in Los Angeles, 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 Los Angeles 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.

Lung Transplant Clinical Trial in Los Angeles, CA

About This Lung Transplant Study in Los Angeles

The purpose of this study is to see if taking the study drug, Belumosudil, for 52 weeks in addition to your usual care and medication, will prevent Chronic Lung Allograft Dysfunction (CLAD) in participants who have a lung biopsy that shows evidence of rejection or inflammation to the transplanted lung(s). For this study, biopsies that show evidence of Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP) or Acute Lung Injury (ALI) are referred to as "Qualifying Biopsies

Sponsor: National Institute of Allergy and Infectious Diseases (NIAID)

Who Can Participate

Inclusion Criteria

Participant and/or parent or guardian must be able to understand the purpose of the study, willing to participate, sign the informed consent, and if applicable assent.

Single or bilateral lung transplant recipient age ≥ 12 years

A qualifying biopsy obtained 60 to 760 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or more of the following features alone or in combination: Acute Rejection (AR), Lymphocytic Bronchiolitis (LB), Organizing Pneumonia (OP), or Acute Lung Injury (ALI). The presence of any grade AR (A1 or greater) or LB (B1 or greater) qualifies for inclusion

Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment with belumosudil or placebo and for at least 3 months after the last dose. Participants must agree to refrain from donating or cryopreserving sperm, eggs (ova or ovocytes) for the purpose of reproduction during treatment with belumosudil or placebo and for at least 3 months after the last dose.

Meeting hematologic laboratory criteria: absolute neutrophil count (ANC) \>= 0.5 x 10(9)/L and platelet count \>= 50 x 10(9)/L within 30 days of enrollment

Meeting all blood chemistry laboratory criteria: aspartate aminotransferase (AST) or alanine transaminase (ALT) \< 2x upper limit of normal (ULN), bilirubin \< 1.5x ULN unless due to Gilbert's syndrome, estimated glomerular filtration rate (eGFR) ≥ 30 mL/min/1.73m2 within 30 days of enrollment

Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative or, if detected, \<200 IU/ml in the absence of any signs of active infection, within 30 days of enrollment

In the absence of contraindications, must have received adult vaccinations or documented immunity as outlined in current National Institute of Allergy and Infectious Diseases (NIAID) Division of Allergy, Immunology, and Transplantation (DAIT) Guidance for Patients in Transplant Trials

Intent to receive calcineurin inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen

Exclusion Criteria

Multi-organ transplants involving more than one organ type (e.g., heart-lung)

Prior organ transplant or prior bone marrow transplant/hematopoietic stem cell transplantation

Greater than 160 days after a qualifying biopsy

Active AMR unless resolved and no treatments with prohibited medications for \> 90 days prior to enrollment

Diagnosed with probable or definite CLAD according to International Society for Heart and Lung Transplantation (ISHLT) guidelines prior to enrollment.

Posttransplant treatment with anti-thymocyte globulin within 30 days or alemtuzumab or any other prohibited medication within 90 days prior to enrollment.

Epstein-Barr virus (EBV) seronegative recipient who received EBV positive donor lung(s).

Treatment with any other investigational pharmacologic agent within 30 days prior to enrollment.

Significant active uncontrolled infection which, in the opinion of the investigator, would place the participant at increased risk.

Current use of sirolimus or everolimus.

Recipient human immunodeficiency virus (HIV) positive.

Recipient Hepatitis B surface antigen positive or Hepatitis B core antibody positive.

Received lung(s) from a donor with known Hepatitis B virus (HBV) including Hepatitis B core antibody positive donors.

Incompletely treated Hepatitis C (absence of ongoing treatment and post-transplant negative HCV PCR)

History of clinically significant surgical factors (such as phrenic nerve damage, transplant lung resection, chest wall surgery), or mechanical factors (such as posttransplant airways disease including bronchial dehiscence, stenosis, dilation, or stent placement, pleural disease) that impedes lung function.

Past or current medical problems, psychosocial concerns, or findings from physical examination or laboratory testing that are not listed above, which, in the opinion of the investigator, may pose undue risk from participation in the study, may interfere with the participant's ability to comply with study requirements, or that may impact the quality or interpretation of the data obtained from the study.

Pregnant or breastfeeding

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 Los Angeles?

Yes, this clinical trial (NCT06476132) has an active research site in Los Angeles, 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.

Lung Transplant Treatment Options in Los Angeles, CA

If you're searching for lung transplant treatment options in Los Angeles, CA, this clinical trial (NCT06476132) 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 Los Angeles research site is actively enrolling participants for this phase 2 clinical trial. You'll receive care from experienced lung transplant 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 lung transplant clinical trials near you to find additional studies recruiting in your area.

Lung Transplant Clinical Trial in Los Angeles, CA

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