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

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ClinicalTrials.gov Identifier: NCT01319591
Recruitment Status : Completed
First Posted : March 21, 2011
Last Update Posted : January 21, 2019
Sponsor:
Information provided by (Responsible Party):
Audrea Szabatura, 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.

Condition or disease
CNS Lymphoma 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.


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Study Type : Observational
Estimated Enrollment : 40 participants
Observational Model: Cohort
Time Perspective: Retrospective
Official Title: Comparison of Creatinine Clearance Calculation Methods for Estimation of Glomerular Filtration Rate in Patients Receiving High-Dose Methotrexate
Study Start Date : March 2011
Actual Primary Completion Date : August 2014
Actual Study Completion Date : September 1, 2017

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Creatinine Lymphoma

Group/Cohort
CNS lymphoma patients



Primary Outcome Measures :
  1. 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 Outcome Measures :
  1. 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.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Sampling Method:   Non-Probability Sample
Study Population
Patients receiving high-dose methotrexate therapy at Dana-Farber Cancer Institute/Brigham and Women's Hospital
Criteria

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

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01319591


Locations
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United States, Massachusetts
Dana-Farber Cancer Institute
Boston, Massachusetts, United States, 02215
Sponsors and Collaborators
Dana-Farber Cancer Institute
Investigators
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Principal Investigator: Audrea H Szabatura, PharmD, BCOP Dana-Farber Cancer Institute

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Responsible Party: Audrea Szabatura, Medication Safety Officer, Dana-Farber Cancer Institute
ClinicalTrials.gov Identifier: NCT01319591     History of Changes
Other Study ID Numbers: 11-043
First Posted: March 21, 2011    Key Record Dates
Last Update Posted: January 21, 2019
Last Verified: January 2019
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: No

Additional relevant MeSH terms:
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Folic Acid Antagonists
Lymphoma
Neoplasms by Histologic Type
Neoplasms
Lymphoproliferative Disorders
Lymphatic Diseases
Immunoproliferative Disorders
Immune System Diseases
Methotrexate
Abortifacient Agents, Nonsteroidal
Abortifacient Agents
Reproductive Control Agents
Physiological Effects of Drugs
Antimetabolites, Antineoplastic
Antimetabolites
Molecular Mechanisms of Pharmacological Action
Antineoplastic Agents
Dermatologic Agents
Enzyme Inhibitors
Immunosuppressive Agents
Immunologic Factors
Antirheumatic Agents
Nucleic Acid Synthesis Inhibitors