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

NCT05730816 | Recruiting Phase 2 DMC FDA Drug

• 2 other identifiers: 2023p000276K23DK125672
• Study Type: interventional
• Target: 130
• Locations: 1 country
• Sites: 1

Brief 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 .

Conditions

Mesothelioma

Keywords

Mesothelioma; Magnesium Sulfate; intraoperative cisplatin

Outcome Measures

Primary Outcomes (2)

• 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

  7 days

• 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.

  7 days

Secondary Outcomes (9)

• Incident AKI

  7 days

• Composite outcome of RRT/in-hospital death

  7 days

• Maximum AKI stage

  7 days

• Renal tubular injury

  2 days

• AUC for platinum concentrations

  2 days

Study Arms (2)

Magnesium Sulfate

EXPERIMENTAL

The 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).

Drug: Magnesium sulfate

Normal Saline

PLACEBO COMPARATOR

Patients 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.

Drug: Normal Saline

Interventions

Magnesium sulfate DRUG

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

Magnesium Sulfate

Normal Saline DRUG

Intravenous infusion of normal saline.

Normal Saline

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

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

You may not qualify 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 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
• 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

Sponsors & Collaborators

• Brigham and Women's Hospital: lead
• National Institutes of Health (NIH): collaborator
• National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK): collaborator

Study Sites (1)

Brigham and Women's Hospital

Boston, Massachusetts, 02130, United States

RECRUITING

MeSH Terms

Conditions

Mesothelioma

Interventions

Magnesium Sulfate; Saline Solution

Condition Hierarchy (Ancestors)

Adenoma; Neoplasms, Glandular and Epithelial; Neoplasms by Histologic Type; Neoplasms; Neoplasms, Mesothelial

Intervention Hierarchy (Ancestors)

Magnesium Compounds; Inorganic Chemicals; Sulfates; Sulfuric Acids; Sulfur Acids; Sulfur Compounds; Crystalloid Solutions; Isotonic Solutions; Solutions; Pharmaceutical Preparations

Study Officials

• Shruti Gupta, MD, MPH

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

• David E. Leaf, MD, MMSc

  Brigham and Women's Hospital

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Shruti Gupta, MD, MPH

CONTACT

617-732-6383; Sgupta21@bwh.harvard.edu

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: NONE
• Purpose: PREVENTION
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director of Onconephrology

Study Record Dates

• First Submitted: February 7, 2023
• First Posted: February 16, 2023
• Study Start: April 4, 2023
• Primary Completion (Estimated): April 3, 2027
• Study Completion (Estimated): January 1, 2028
• Last Updated: November 21, 2025

Record last verified: 2025-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: Data can be shared no earlier than 1 year following the date of publication
• Access Criteria: BWH - Contact the Partners Innovations team at http://www.partners.org/innovation DFCI - Contact the Belfer Office for Dana-Farber Innovations (BODFI) at innovation@dfci.harvard.edu

Locations

US (1)