BridgeMD
Prevention study for Mesothelioma
Official title MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI
ClinicalTrials.gov ID: NCT05730816
What this study is testing
What is Magnesium sulfate?
Magnesium sulfate is an investigational medicine, given as an infusion into a vein, being studied as a potential treatment for mesothelioma.
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
- In this research study, investigators will test whether prophylactic high-dose IV Mg administration attenuates the risk of AKI in patients with malignant mesothelioma receiving intraoperative chemotherapy (HIOC) with cisplatin compared to placebo .
- Phase 2: a mid-size study of how well it works
- You might receive a placebo (an inactive treatment) instead of the study drug, decided by chance.
A plain-language read of the study's public ClinicalTrials.gov listing. The study team confirms the details.
Who can take part
Ages 18 and older
You may be able to join if
- 1\. Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon
You likely can't join if
- eGFR\<45 ml/min/1.73m2 on either screening labs or preoperative labs, or end-stage kidney disease receiving renal replacement therapy. Screening labs...
- Serum Mg \>3 mg/dl on either screening labs or preoperative labs
- Pregnant/breastfeeding
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis)
- Coronary artery disease, defined as any of the following in the prior year: a positive stress test; coronary angiogram indicating 1 or more vessels...
- Sinus bradycardia, defined as a heart rate (HR) \<55 beats per minute (bpm) detected on any ECG in the preceding 6 months
See the full eligibility criteria
- 1\. Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon
- eGFR\<45 ml/min/1.73m2 on either screening labs or preoperative labs, or end-stage kidney disease receiving renal replacement therapy. Screening labs refer to those obtained at the preoperative visit with the surgeon or...
- Serum Mg \>3 mg/dl on either screening labs or preoperative labs
- Pregnant/breastfeeding
- Neuromuscular disease (e.g., myasthenia gravis, amyotrophic lateral sclerosis, multiple sclerosis, muscular dystrophy, myositis)
- Coronary artery disease, defined as any of the following in the prior year: a positive stress test; coronary angiogram indicating 1 or more vessels with \>70% stenosis; percutaneous coronary intervention with stents; or...
- Sinus bradycardia, defined as a heart rate (HR) \<55 beats per minute (bpm) detected on any ECG in the preceding 6 months
- High grade AV block (2nd degree AV block type II or 3rd degree AV block) without a pacemaker
- Positive COVID test in the 10 days prior to surgery
- Prisoner
- Hypersensitivity to Mg sulfate
- Concurrent participation in a study with an alternative experimental therapy that may interact with IV Mg
- Any condition that, in the view of the PI, might place the patient at increased risk or compromise the integrity of the study
- Conflict with other study
The study team makes the final eligibility decision.
Where it's taking place
- Boston, Massachusetts, United States
Compensation & support
Compensation mentioned.
ClinicalTrials.gov doesn't provide a reliable structured field for payment or travel support - confirm details with the study team.
Questions & answers
Do participants get paid in this trial?
This study's listing includes signals that participants may be compensated or receive a stipend. Amounts vary and are set by the study team - confirm the details with them.
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, 18 years and older. The study team makes the final eligibility decision.
Where is this trial taking place?
Study sites include Boston, Massachusetts, United States. 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.