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mTOR Inhibitor
Sirolimus for Lymphangioleiomyomatosis (MILED Trial)
Phase 3
Recruiting
Research Sponsored by University of Cincinnati
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Diagnosis of LAM as determined by compatible lung CT and one of the following: biopsy (lung, abdominal mass, lymph node or kidney) or cytology from thoracic or abdominal sources revealing LAM, or tuberous sclerosis, angiomyolipomata (diagnosed by CT, MRI by the site radiologist or biopsy) or chylous pleural effusion (verified by tap), or VEGF-D level ≥ 800 pg/ml
Female, age 18 or over
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 2 years
Awards & highlights
MILED Trial Summary
This trial will test if sirolimus can prevent kidney disease from getting worse.
Who is the study for?
This trial is for women aged 18 or older with Lymphangioleiomyomatosis (LAM), who have certain markers indicating the disease may get worse. They must not be pregnant, planning pregnancy soon, or have used sirolimus recently. Other health conditions and recent surgeries also affect eligibility.Check my eligibility
What is being tested?
The study tests whether taking a low dose of Sirolimus early on can prevent LAM from progressing to more advanced stages. It's designed as a long-term intervention to see if this treatment makes a difference over time.See study design
What are the potential side effects?
Sirolimus can cause side effects like mouth sores, increased cholesterol levels, skin rashes, and potentially impact blood counts and kidney function. Each person might experience these differently.
MILED Trial Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I have been diagnosed with LAM based on lung CT and other specific tests or conditions.
Select...
I am a woman aged 18 or older.
MILED Trial Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 2 years
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~2 years
Treatment Details
Study Objectives
Outcome measures can provide a clearer picture of what you can expect from a treatment.Primary outcome measures
Forced Expiratory Volume in 1 Second (FEV1 slope)
Secondary outcome measures
Diffusing Capacity for Carbon Monoxide (DLCO)
Total Lung Capacity (TLC)
MILED Trial Design
2Treatment groups
Active Control
Placebo Group
Group I: TreatmentActive Control1 Intervention
Over-encapsulated 1 mg sirolimus tablet
Group II: PlaceboPlacebo Group1 Intervention
Overencapsulated matrix
Find a Location
Who is running the clinical trial?
National Center for Advancing Translational Sciences (NCATS)NIH
321 Previous Clinical Trials
401,689 Total Patients Enrolled
National Heart, Lung, and Blood Institute (NHLBI)NIH
3,836 Previous Clinical Trials
47,311,052 Total Patients Enrolled
12 Trials studying Lymphangioleiomyomatosis
3,373 Patients Enrolled for Lymphangioleiomyomatosis
The LAM FoundationOTHER
4 Previous Clinical Trials
640 Total Patients Enrolled
4 Trials studying Lymphangioleiomyomatosis
640 Patients Enrolled for Lymphangioleiomyomatosis
Media Library
Eligibility Criteria:
This trial includes the following eligibility criteria:- I have not had a collapsed lung in the last month.Your blood oxygen level is below 90% when measured while resting.Your oxygen level drops below 85% during exercise.My blood, kidney, liver, and metabolic tests are within normal ranges.I have been diagnosed with LAM based on lung CT and other specific tests or conditions.Your lung function, measured after using a bronchodilator, is better than 70%.I have signs that my lung condition, LAM, is getting worse.I had surgery that required opening my body or more than 2 stitches within the last 3 weeks.Your lung function test shows that your ability to transfer oxygen is less than 60% of what is expected.I cannot go to clinic visits or do lung function tests.You are allergic to sirolimus.I have not had cancer in the last 2 years, except for skin cancer.I haven't taken sirolimus, everolimus, or any experimental LAM treatments in the last 30 days.I have not taken estrogen medications in the last 30 days.I have fluid in my chest or abdomen affecting my breathing, as confirmed by a doctor.I have had a heart attack, chest pain, or stroke due to clogged arteries.I am a woman aged 18 or older.You have had a lung transplant in the past or are currently on a waiting list for a lung transplant.I do not have any ongoing infections like TB or hepatitis B/C.My doctor thinks I need mTOR inhibitor treatment soon.
Research Study Groups:
This trial has the following groups:- Group 1: Treatment
- Group 2: Placebo
Awards:
This trial has 1 awards, including:- Pivotal Trial - The final step before approval, pivotal trials feature drugs that have already shown basic safety & efficacy.
Timeline:
This trial has the following timeline:- Screening: It may take up to 3 Weeks to process to see if you qualify in this trial.
- Treatment: The duration you will receive the treatment varies.
- Follow Ups: You may be asked to continue sharing information regarding the trial for 6 Months after you stop receiving the treatment.
Frequently Asked Questions
These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.
What is the primary reason people use this medication?
"This treatment can be used to manage kidney, liver, and disease-related rejections following a transplant."
Answered by AI
Has this medication been federally mandated for use?
"This treatment received a safety score of 3 from our analysts at Power. This is due to the fact that this is a Phase 3 trial, which provides some evidence of efficacy in addition to multiple rounds of data supporting safety."
Answered by AI
How many candidates are being given the opportunity to participate in this clinical trial?
"In order for this trial to be completed, 60 patients who fit the bill in terms of specified inclusion criteria are required. There are a number of sites where patients can participate, such as University of Cincinnati and Swedish Health."
Answered by AI
From how many different locations is this medical trial being administered?
"This trial has 5 recruiting sites, which include the University of Cincinnati, Swedish Health in Seattle, and Columbia University."
Answered by AI
What other research has been published on this therapy?
"There are a total of 130 ongoing studies investigating this potential treatment, 13 of which have reached Phase 3. The highest concentration of these trials is in Cincinnati, Ohio; however, there are 1084 locations worldwide running some form of study related to this topic."
Answered by AI
Is this study looking for more participants?
"Yes, this study is still open and looking for volunteers. The clinicaltrials.gov website shows that the trial was first posted on January 1st, 2018 and last updated on January 11th, 2022."
Answered by AI
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