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MesotheliomaPhase 2MAGIC-AKINCT05730816

MAGIC AKI: Magnesium for the Prevention of HIOC-Associated AKI

A Phase 2 study testing Magnesium sulfate and Normal Saline in people with Mesothelioma, run by Brigham and Women's Hospital at 1 site in United States.

Recruiting

Looking for participants now. Contact the study team or a site below to ask about taking part.

Sites and contacts
Official record
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Trial summary

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 . Read more about this study

Who is it for?
Ages 18 years and older
Conditions the study is for
Mesothelioma
What is being tested?
Magnesium sulfate and Normal Saline
Type of treatment
Injection or infusion
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
130 participants
Where
1 siteUnited States
Study dates
4 Apr 2023to 1 Jan 2028
Phase
Phase 2
Are there results?
Not yet: the study is under way

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 years and older
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 1. • Adult patients (≥18 years old) with malignant mesothelioma undergoing surgery with HIOC with Dr. Raphael Bueno or another BWH thoracic surgeon

Who cannot join

  • 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 within 90 days prior, whereas preoperative labs are obtained on the day of admission (typically one to three days priors to surgery).
  • 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 coronary artery bypass graft surgery
  • Sinus bradycardia, defined as a heart rate (HR) <55 beats per minute (bpm) detected on any ECG in the preceding 6 months
Show all 13Show fewer
  • 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

Trial locations and contacts

1 site in 1 country. Contact the study team or a site near you to ask about taking part.

Shruti Gupta, MD, MPH contact

617-732-6383

Sgupta21@bwh.harvard.edu

United States1 site, 1 recruiting

  • Brigham and Women's Hospital

    Boston, Massachusetts, 02130

    Shruti Gupta, sgupta21@bwh.harvard.edu

    David E. Leaf, deleaf@bwh.harvard.edu

    Recruiting

Other trials in United States

About this study

Official title: MAGIC-AKI: Magnesium for the Prevention of Hyperthermic Intraoperative Cisplatin-Associated AKI

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

.

Read the detailed description

In this phase 2, open-label randomized, placebo-controlled trial, investigators will test whether prophylactic high-dose IV Mg administration attenuates the risk of HIOC-associated AKI in patients with malignant mesothelioma undergoing surgery with HIOCC. Investigators will randomly assign 130 patients to receive IV Mg versus an equal volume of normal saline (0.9% NS) placebo, of whom it is anticipated 80 will complete the study. Investigators will also collect blood and urine pre- and postoperatively for exploration of secondary outcomes.

Investigators will screen for eligibility at participant's preoperative visit with their thoracic surgeon. Intravenous magnesium will be administered as a continuous infusion, soon after induction and stabilization by anesthesia in the operating room. The magnesium drip will start at 1 g/hour and will be titrated to achieve target levels of 3-5 mg/dl. The total duration of the infusion will be 24 hours.

Conditions
Mesothelioma
Being tested
Magnesium sulfate, Normal Saline
Keywords
Mesothelioma, Magnesium Sulfate, intraoperative cisplatin
Medical subject headings
Mesothelioma

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • Magnesium sulfateDrug

    Intravenous infusion of magnesium sulfate prior to intraoperative chemotherapy with cisplatin.

  • Normal SalineDrug

    Intravenous infusion of normal saline.

Study groups in NCT05730816
Study groupRoleWhat they receive
Magnesium SulfateExperimentalThe IV Mg will start at 1 g/hour (25 ml/hour) within one hour following induction of anesthesia and stabilization of the patient. The infusion will continue for 24 hours and serum Mg levels will be monitored every 4 hours (+/-1 hour) for 28 hours following initiation of the Mg. Dose adjustments to the Mg infusion will be made as necessary to reach target serum Mg levels (3-5 mg/dl).
Receives: Drug: Magnesium sulfate
Normal SalinePlacebo comparatorPatients randomized to placebo will receive an equal volume of normal saline (0.9% NS) placebo which will be administered as a continuous infusion at 25 ml/hour. The infusion will continue for 24 hours.
Receives: Drug: Normal Saline

What is being measured

The primary outcome is the main question the study is designed to answer.

  1. AUC of SCr measured daily over 7 days in Mg- versus placebo-treated patients

    The primary endpoint is the area under the curve (AUC) of SCr measured daily over 7 days in Mg- versus placebo-treated patients

    Measured: 7 days

  2. Composite Global Rank

    As a secondary endpoint, investigators will construct a composite global rank endpoint in which the highest rank is assigned to those who die within 7 days, the second highest rank is assigned to those who survive but require RRT within 7 days, and all others ranked according to their SCr AUC, since RRT and death are important competing risks.

    Measured: 7 days

Secondary outcomes (9)

  1. Incident AKI

    Urine output <0.5 ml/kg/h x consecutive 6 hours in the first 48 hours following surgery with HIOC (this will only be assessed for the first 48 hours, as patients are transferred out of the ICU and/or their foley is removed, which prevents accurate hourly assessment of UOP); An absolute increase in SCr ≥0.3 mg/dl within 48 hours; C) A relative increase in SCr ≥50% compared to the baseline value in the first 7 days; D) Receipt of RRT in the first 7 days

    Measured: 7 days

  2. Composite outcome of RRT/in-hospital death

    Composite outcome

    Measured: 7 days

  3. Maximum AKI stage

    Based on KDIGO staging

    Measured: 7 days

  4. Renal tubular injury

    AUC of uNGAL, uKIM-1, and pKIM-1 at hours +4, +12, and +36 in relation to HIOC administration

    Measured: 2 days

  5. AUC for platinum concentrations

    Using blood and urine collected at various time points

    Measured: 2 days

  6. Vasoactive-inotropic score (VIS)

    Assessed every 4 hours for the first 24 hours, and then every 8 hours for the next 24 hours, in relation to the start of the Mg infusion. The VIS is a validated method for integrating all vasoactive medications (i.e., vasopressors and inotropes) and their doses on an hourly basis into a single measure, and has been used in multiple settings

    Measured: 2 days

  7. Proportion of patients with serum Mg levels in the 3-5 mg/dl range in the treatment group

    Between hours +8 and +24 in relation to the start of the Mg infusion

    Measured: 1 day

  8. New onset of atrial fibrillation

    Confirmed on an EKG

    Measured: 7 days

  9. Myocardial injury

    Defined as clinical evidence of myocardial injury and a troponin level above the 99th percentile

    Measured: 7 days

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted16 Feb 2023
  2. Study start4 Apr 2023
  3. Primary completion3 Apr 2027 (estimated)
  4. Study completion1 Jan 2028 (estimated)

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Prevention
Allocation
Randomised
Intervention model
Parallel groups
Masking
None (open label)
Enrolment
130 participants (estimated)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05730816
Sponsor's protocol ID
2023p000276
Other IDs
K23DK125672
Acronym
MAGIC-AKI
Status last verified
Nov 2025
First submitted
7 Feb 2023
Last updated
21 Nov 2025
Results posted
No
Data monitoring committee
Yes
FDA-regulated drug
Yes
FDA-regulated device
No
Individual data sharing
Yes: The Dana-Farber / Harvard Cancer Center encourages and supports the responsible and ethical sharing of data from clinical trials. De-identified participant data from the final research dataset used in the published manuscript may only be shared under the terms of a Data Use Agreement. Requests may be directed to: \[contact information for Sponsor Investigator or designee\]. The protocol and statistical analysis plan will be made available on Clinicaltrials.gov only as required by federal regulation or as a condition of awards and agreements supporting the research.

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Magnesium sulfate and Normal Saline in people with Mesothelioma, run by Brigham and Women's Hospital at 1 site in United States.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 1 inclusion and 13 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: looking for participants now, as of the sponsor's last update on 21 Nov 2025. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

This study is still under way. Results are not available in the source record yet.

How can a doctor refer a patient or contact the research team?

Contact Shruti Gupta, MD, MPH (617-732-6383, Sgupta21@bwh.harvard.edu), or a site near the patient. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

AUC of SCr measured daily over 7 days in Mg- versus placebo-treated patients (time frame: 7 days). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05730816.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 21 Nov 2025; AzTrials last refreshed its copy on 8 Nov 2026.

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