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

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

Status

Completed

Phases

Unknown

Study type

Observational

Source

ClinicalTrials.gov

Registry ID

NCT01319591

Enrollment

Registered

2011-03-21

Start date

2011-03-31

Completion date

2017-09-01

Last updated

2019-01-22

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

CNS Involvement of Systemic Lymphoma, CNS Lymphoma

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.

Interventions

None listed

Study design

Observational model

COHORT

Time perspective

RETROSPECTIVE

Eligibility

Sex/Gender

ALL

Age

18 Years to No maximum

Healthy volunteers

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

Design outcomes

Primary

Measure	Time frame	Description
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

Measure	Time frame	Description
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.

Countries

United States

Outcome results