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


N/A
18 Years
N/A
Open (Enrolling)
Both
CNS Lymphoma, CNS Involvement of Systemic Lymphoma

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Trial Information

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


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.


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

Type of Study:

Observational

Study Design:

Observational Model: Cohort, Time Perspective: Retrospective

Outcome Measure:

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

Outcome Description:

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.

Outcome Time Frame:

1 year

Safety Issue:

No

Principal Investigator

Audrea H Szabatura, PharmD, BCOP

Investigator Role:

Principal Investigator

Investigator Affiliation:

Dana-Farber Cancer Institute

Authority:

United States: Institutional Review Board

Study ID:

11-043

NCT ID:

NCT01319591

Start Date:

March 2011

Completion Date:

December 2013

Related Keywords:

  • CNS Lymphoma
  • CNS Involvement of Systemic Lymphoma
  • Lymphoma

Name

Location
Dana-Farber Cancer Institute Boston, Massachusetts  02115