Chemotherapy Toxicity Reduction Via Urea Cycle Support

ClinicalTrials.gov ID: NCT00223730

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Brief summary

Reproduced verbatim from the official ClinicalTrials.gov record. Not medical advice.

Patients undergoing bone marrow transplantation (BMT) and peripheral blood stem cell transplants (PBSCT) frequently develop organ dysfunctions, much of which may be initiated by damage to the liver and to cells lining blood vessels. We, the researchers at Vanderbilt University, propose to perform a randomized, prospective, double-blind, placebo-controlled study of 144 patients undergoing allogeneic marrow transplantation. The treatment is aimed at supporting hepatic urea cycle function in patients receiving escalated dose chemotherapy/BMT. By so doing we hope to prevent development of hepatic venoocclusive disease (HVOD) and acute lung injury (ALI), two morbid complications of BMT. Patients will be randomized to receive oral citrulline, a urea cycle amino acid intermediate, or placebo beginning before conditioning therapy and continuing until 21 days after BMT. All patients will be followed for 100 days after study enrollment with intensive data collection.

Study identification

NCT ID: NCT00223730
Recruitment status: Completed
Study type: Interventional
Phase: Phase 2
Lead sponsor: Vanderbilt University; Other
Enrollment: 100 participants

Conditions and interventions

Conditions

Cancer

Interventions

Citrulline Drug
Placebo Drug

Drug

Eligibility (public fields only)

Age range: 13 Years to 65 Years
Sex: All
Healthy volunteers: Healthy volunteers not accepted

This page does not interpret eligibility. Detailed inclusion and exclusion criteria are on the official ClinicalTrials.gov record.

Study timeline

Start date: Oct 2001 (Type not available)
Primary completion: Dec 2007 (Actual)
Completion: Dec 2007 (Actual)
Last update posted: Nov 2, 2016

2001 – 2007

United States locations

U.S. sites: 1
U.S. states: 1
U.S. cities: 1

Facility	City	State	ZIP	Site status
Vanderbilt University Medical Center	Nashville	Tennessee	37232	—

Site contact phone numbers, emails, and investigator names are intentionally not displayed here. Open the official ClinicalTrials.gov record for site contact information.

About this trial record page

What this page shows: Public field values for ClinicalTrials.gov record NCT00223730, including study identification, conditions, interventions, eligibility (age, sex, healthy volunteer), timeline, and U.S. site list.
What this page does not do: No medical advice, eligibility judgments, treatment recommendations, study quality scoring, or AI-generated medical summaries. No site contact phone numbers, emails, or investigator names.
Where the data comes from: Sourced from the official ClinicalTrials.gov public API. The official record is the source of truth.
Last refresh: Last update posted Nov 2, 2016 · Synced Nov 13, 2026