Comparison of Markers of Kidney Function

Completed

Conditions studied: Chronic Kidney Disease, Renal Insufficiency

In brief

Glomerular filtration rate (GFR) is the best known measurement of kidney function. Serum creatinine (blood test) is the most commonly used marker to predict GFR. It is a convenient, inexpensive test that involves a single blood draw with rapid results. However, creatinine has several limitations because its blood level is dependent on age, body mass, and sex. One of the gold standards for measuring GFR is plasma clearance of an IV injected agent, iohexol. It has been found to be safe and nontoxic in prior studies, but is not practical in the clinical setting due to the need for several timed blood draws. Recent studies have investigated the use of cystatin C as an alternative marker to predict GFR. Cystatin C also involves only a single blood draw, and has less confounding factors than creatinine since it is independent of age, body mass, and sex. Currently, it remains controversial whether cystatin C is a significantly better biomarker of estimated GFR than creatinine. To date, there has not been a large prospective cohort study to compare cystatin C and creatinine in pediatric kidney transplant patients who are on maintenance immunosuppression (anti-rejection drugs). Accurate measurement and early detection of deterioration of GFR is critical in the care of this patient population. The purpose of this study is to assess the accuracy of estimating GFR by using cystatin C versus creatinine clearance equations when compared to the surrogate gold standard of iohexol GFR in pediatric renal transplant patients.

Key facts

Study ID

NCT01403766

Run by

University of California, Los Angeles

People needed

17

Starts

2011-08-01

Expected to finish

2012-12-01

Last updated by the study team

2020-11-17

Who can join

Age: 1 and older, up to 18. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• Renal transplant patient aged 1 to <19 years old
• Stable allograft function (no history of biopsy proven acute rejection or increase of creatinine of > 10% from baseline in the past 6 months)
• No changes in maintenance immunosuppression in the month before the protocol biopsy
• Subject and/or parent must be able to understand and provide informed consent

You may not qualify if…

• Biopsy proven acute rejection in the past 6 months
• Change in maintenance immunosuppression in the month before the protocol biopsy
• Known diabetes mellitus
• Known thyroid dysfunction
• Allergy to Iohexol or other contrast media
• Inability or unwillingness of a participant or their legal guardian to give written informed consent or comply with the study protocol

Where it is running

• University of California, Los Angeles — Los Angeles, California, United States

Full record on ClinicalTrials.gov

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