CompletedPhase 1

Pravastatin as a Prophylactic to Reduce Endothelial Injury in Pediatric Patients With Elevated Body Mass Index

United States25 participantsStarted 2023-01-27

Plain-language summary

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.

Who can participate

Age range2 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

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

What they're measuring

Percentage of participants who developed clinically significant transaminitis, renal dysfunction and rhabdomyolysis

Timeframe: Until day 35 after bone marrow transplant when pravastatin is discontinued

Percentage of participants who adhered to the medication plan

Timeframe: Until day 35 after bone marrow transplant when pravastatin is discontinued

Trial details

NCT IDNCT05524246

SponsorChildren's Hospital Medical Center, Cincinnati

Sponsor typeOTHER

Study typeINTERVENTIONAL

Primary completion2024-12-31

View on ClinicalTrials.gov More Hematopoietic Stem Cell Transplant (HSCT) trials

Plain-language summary

Who can participate

Age range2 Years – 25 Years

SexALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

What they're measuring

Percentage of participants who developed clinically significant transaminitis, renal dysfunction and rhabdomyolysis

Timeframe: Until day 35 after bone marrow transplant when pravastatin is discontinued

Percentage of participants who adhered to the medication plan

Timeframe: Until day 35 after bone marrow transplant when pravastatin is discontinued