Pilot Trial of Pravastatin as a Novel Prophylactic Medicine to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

  • End date
    Sep 22, 2025
  • participants needed
  • sponsor
    Children's Hospital Medical Center, Cincinnati
Updated on 22 October 2022


Chemotherapy and radiation used in patients undergoing bone marrow transplant (BMT) disrupts the endothelial lining (a thin layer of cells inside the blood vessels) which is found all throughout the body including the kidney, heart, lungs, and intestines. Disruption of this endothelial lining can lead to complications such as graft-vs-host disease (GVHD), thrombotic microangiopathy (TMA) and veno-occlusive disease (VOD). The purpose of this research study is to help investigators see if pravastatin is safe and well tolerated in patients undergoing BMT to see if it will reduce endothelial injury after BMT.

The investigator hypothesizes that prophylactic pravastatin in pediatric allogeneic hematopoietic stem cell transplant recipients with elevated BMI is safe and feasible.

Condition Hematopoietic Stem Cell Transplant (HSCT), Endothelial Injury
Treatment Pravastatin
Clinical Study IdentifierNCT05524246
SponsorChildren's Hospital Medical Center, Cincinnati
Last Modified on22 October 2022


Yes No Not Sure

Inclusion Criteria

Scheduled for allogeneic stem cell transplant
Ages ≥ 2 - ≤ 25 years old
Elevated BMI defined by the Center for Disease Control and Prevention definitions. Both overweight (BMI between 85th-94th percentile) and obese (BMI >95th percentile) patients are eligible
All diagnoses are eligible

Exclusion Criteria

Patients with documented anaphylaxis to pravastatin
Patients will be ineligible if they are unable to take medication orally or enterally (i.e. intestinal failure)
Patients with elevations in ALT/AST levels 3x ULN at time of enrollment
Patients with renal impairment as clinically measured (GFR <50 ml/min/1.73m2) at time of enrollment
Patients with known neuromuscular and metabolic disorders associated with an increased risk of rhabdomyolysis (ie metabolic muscle disorders, mitochondrial disorders, and muscular dystrophies)
Patients taking any drugs that are known substrates for OATP1B1 and OATP1B3 transporters
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