Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate
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|ClinicalTrials.gov Identifier: NCT01319591|
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : January 21, 2019
|Condition or disease|
|CNS Lymphoma CNS Involvement of Systemic Lymphoma|
We intend to perform a retrospective chart review to identify a serum creatinine-based equation that gives the best estimate of CrCl as compared with an equation derived from a 24-hour urine collection.
Study subjects will be identified using the Brigham and Women's Hospital and Dana-Farber Cancer Institute's Adult Pharmacy systems to identify patients who received high-dose methotrexate. Data will be collected starting with December 31, 2010 and proceeding chronologically backwards until the target enrollment of 40 patients is reached.
|Study Type :||Observational|
|Estimated Enrollment :||40 participants|
|Official Title:||Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate|
|Study Start Date :||March 2011|
|Actual Primary Completion Date :||August 2014|
|Actual Study Completion Date :||September 1, 2017|
|CNS lymphoma patients|
- To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula. [ Time Frame: 1 year ]Serum creatinine-based equations to be included in that analysis are: Cockcroft-Gault with the following weight descriptors; ideal body weight, actual body weight, and adjusted body weight; Modified MDRD; CKD-EPI.
- To further compare each formula in a different subset of patients. [ Time Frame: 1 year ]To further compare each formula in a different subset of patients: Age < 65 years and >/= 65 years; body mass index < 25, 25-30, 30-35, and > 35; serum creatinine <1.5 mg/dL and >/= 1.5 mg/dL.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319591
|United States, Massachusetts|
|Dana-Farber Cancer Institute|
|Boston, Massachusetts, United States, 02215|
|Principal Investigator:||Audrea H Szabatura, PharmD, BCOP||Dana-Farber Cancer Institute|