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New treatment option for Lung Transplant
Official title Belumosudil to Block Chronic Lung Allograft Dysfunction (CLAD) in High Risk Lung Transplant Recipients
ClinicalTrials.gov ID: NCT06476132
What this study is testing
What is Belumosudil?
Belumosudil is an investigational medicine, given as an once-daily, being studied as a potential treatment for lung transplant.
Plain-language explanation of the investigational treatment - it is being studied and is not an approved or proven therapy. The study team can confirm the details.
- What it's testing
- 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"; patients who had evidence of one or more of these conditions on a recent biopsy are eligible for enrollment in this study.
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 12 and older
You may be able to join if
- 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...
- Single or bilateral lung transplant recipient age ≥ 12 years
- A qualifying biopsy obtained 60 to 550 days after lung transplant with evidence of allograft injury histology; a qualifying biopsy must have one or...
- Females of reproductive potential and males with female partners of reproductive potential must agree to use effective contraception during treatment...
- 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...
You likely can't join if
- 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 120 days after a qualifying biopsy
- Clinical AMR prior to enrollment. Subclinical AMR is permitted if 90 days or greater 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...
See the full eligibility 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 550 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...
- 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...
- 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...
- Cytomegalovirus (CMV) polymerase chain reaction (PCR) negative 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...
- Receiving Calcineurin Inhibitor (CNI)-based maintenance Immunosuppression (IS) regimen
- 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 120 days after a qualifying biopsy
- Clinical AMR prior to enrollment. Subclinical AMR is permitted if 90 days or greater 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.
- Recipient history of Hepatitis C, Hepatitis C seropositive, or received lung(s) from a donor with known Hepatitis C (participants who have 3 months of documented consecutive undetected Hepatitis C virus PCR after...
- 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...
- 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...
- Pregnant or breastfeeding
The study team makes the final eligibility decision.
Where it's taking place
- Los Angeles, California, United States
- Palo Alto, California, United States
- Baltimore, Maryland, United States
- Minneapolis, Minnesota, United States
- St Louis, Missouri, United States
- New York, New York, United States
- Durham, North Carolina, United States
- Cincinnati, Ohio, United States
- Cleveland, Ohio, United States
- Philadelphia, Pennsylvania, United States
- Nashville, Tennessee, United States
- Toronto, Ontario, Canada
Questions & answers
Do participants get paid in this trial?
This listing doesn't specify compensation. Many trials still reimburse travel or offer a stipend, so it's worth asking the study team when you connect.
Is it free to join, and do I need insurance?
Searching and applying through BridgeMD is free. In clinical trials the study-related treatment and visits are generally provided at no cost to you. You usually don't need insurance to take part - confirm specifics with the study team.
How long does this study last?
The listing doesn't state an exact length. The study team walks you through the schedule and number of visits before you decide to enroll.
Who can join this trial?
This study is enrolling all sexes, 12 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Los Angeles, California, United States; Palo Alto, California, United States; Baltimore, Maryland, United States; Minneapolis, Minnesota, United States; St Louis, Missouri, United States; New York, New York, United States and 6 more location(s). Enter your location above to see the nearest site and check your eligibility.
Explore other conditions
BridgeMD is an information and trial-matching tool - not medical advice, and not the study sponsor. Details come from ClinicalTrials.gov; the study team decides eligibility.