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

CNS Lymphoma Clinical Trial

Official title:

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

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01319591
• Other study ID #: 11-043
• Status: Completed
• Start date: March 2011
• Est. completion date: September 1, 2017

Study information

• Verified date: January 2019
• Source: Dana-Farber Cancer Institute
• Contact: n/a
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 40
• Est. completion date: September 1, 2017
• Est. primary completion date: August 2014
• Accepts healthy volunteers: No
• Gender: All
• Age group: 18 Years and older

Eligibility

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

Related Conditions & MeSH terms

• CNS Involvement of Systemic Lymphoma
• CNS Lymphoma
• Lymphoma

Locations

Country	Name	City	State
United States	Dana-Farber Cancer Institute	Boston	Massachusetts

Sponsors (1)

Lead Sponsor	Collaborator
Dana-Farber Cancer Institute

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	To identify a serum creatinine-based equation that gives the best estimate of CrCl as compared to a measured creatinine clearance formula.	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.	1 year
Secondary	To further compare each formula in a different subset of patients.	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.	1 year