Comparison of Creatinine Clearance Calculation for Estimation of GFR in Patients Receiving HD Methotrexate

The purpose of this study is to compare different estimates of calculating creatinine clearance by mathematical formula and compare them to creatinine clearance based on a timed urine collection in patients who received high-dose methotrexate for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma.

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Key information

Conditions

CNS Lymphoma CNS Involvement of Systemic Lymphoma

Age range

18 year and older

Sex eligibility

All sexes

Study type

Observational

Primary location

Dana-Farber Cancer Institute

Boston, Massachusetts, 02215, United States

About this study

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.

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

Inclusion criteria

Age >/= 18 years
Received high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital for the treatment of primary CNS lymphoma or CNS involvement of systemic lymphoma
Available timed urine collection within 1 week of HDMTX

Exclusion criteria

Receiving high-dose methotrexate for indications other than primary CNS lymphoma or CNS involvement of systemic lymphoma
Documented viral hepatitis

Treatment and study plan

Primary outcomes

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.

Secondary outcomes

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.

Sponsors and collaborators

Lead sponsor

Dana-Farber Cancer Institute

Other

Registry information

Official study title

Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate

Important dates

Study start: 2011
Primary completion: 2014
Study completion: 2017
First posted: Mar 21, 2011
Registry last updated: Jan 22, 2019

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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Completed