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

Completed

• Conditions: CNS Lymphoma; CNS Involvement of Systemic Lymphoma

• Registration Number: NCT01319591
• Lead Sponsor: Dana-Farber Cancer Institute

Brief Summary

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.

Detailed Description

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 Timeline

• Study Start: 2011-03
• Study First Submitted: 2011-03-18
• Study First Submitted QC: 2011-03-18
• Study First Posted: 2011-03-21
• Primary Completion: 2014-08
• Study Completion: 2017-09-01
• Status Verified: 2019-01
• Last Update Submitted: 2019-01-18
• Last Update Posted: 2019-01-22

Recruitment & Eligibility

• Status: COMPLETED
• Sex: All
• Target Recruitment: 40

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

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Exclusion Criteria

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

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Study & Design

• Study Type: OBSERVATIONAL
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.	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 Outcome Measures

Name	Time	Method
To further compare each formula in a different subset of patients.	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.

Trial Locations

Locations (1)

Dana-Farber Cancer Institute; 🇺🇸 Boston, Massachusetts, United States