A Pilot Study of Cimetidine-aided Creatinine Clearance to Assess Glomerular Filtration Rate in Child Determination of early or subtle changes in glomerular filtration rate (GFR) is essential in the management of patients with many renal diseases. GFR is used in making decisions about medical regimens, monitoring disease progression, and initiating and monitoring drug therapy. Inulin clearance is the gold standard procedure used to determine GFR. Creatinine clearance measurements are used to estimate GFR since inulin studies are difficult to perform and expensive. However, creatinine clearance overpredicts GFR because creatinine is also secreted in the renal tubules. Therefore, creatinine clearance measurements are not as sensitive at detecting changes in GFR as is desirable. Cimetidine is an antiulcer agent that also blocks the tubular secretion of creatinine; thus creatinine acts like inulin. Cimetidine-aided creatinine clearance studies in adults show an excellent correlation with inulin clearance and GFR. Therefore, we propose to study the hypothesis that a cimetidine-aided creatinine clearance approximates inulin clearance and can be used to assess GFR in children. We hope to enroll patients who are already enrolled in the hypoparathyroid and cystinosis studies at NIH. These patients are already undergoing two 24-hour creatinine clearance studies. Patients will be asked to undergo a pretreatment with cimetidine before the second 24-hour creatinine clearance and then have an inulin clearance study performed. To detect a 20 percent difference between the two creatinine clearance regimens with 80 percent power and a two-tailed significance level of 0.05, eight available patients need to be enrolled. Twenty percent is an estimate of the standard deviation. With the data collected, we will also identify a ratio of cimetidine-aided creatinine clearance to inulin clearance and identify the precision of that estimate. We will also estab-lish the confidence interval around that estimate. We request enrollment of up to 14 patients in anticipation of some patients withdrawing from the study. Five patients were enrolled in the study. The inulin plasma and urine samples are being shipped to the Mayo Clinic next week. We anticipate that the results of the laboratory tests will be reported to us within 2 to 4 weeks. Results will be sent to Linda Young, Pharm.D. at the University of Tennessee for analysis. Dr. Young and Dr. Calis will then write up the results of the study. This study is terminated.
