Comparison of inulin clearance with 2-h creatinine clearance in Japanese pediatric patients with renal disease: open-label phase 3 study of inulin
| Autor: | Takafumi Sano, Naoya Fujita, Masaki Yamamoto, Kazumoto Iijima, Koichi Kamei, Masahiko Fushimi, Riku Hamada, Kenji Ishikura, Tomoyuki Sakai, Yoshimitsu Gotoh, Osamu Uemura |
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| Jazyk: | angličtina |
| Rok vydání: | 2021 |
| Předmět: |
Nephrology
medicine.medical_specialty Adolescent Physiology Inulin Urology Phases of clinical research Renal function Urine urologic and male genital diseases Kidney Function Tests chemistry.chemical_compound Japan Physiology (medical) Internal medicine Chronic kidney disease medicine Clinical endpoint Humans Adverse effect Child Children Inulin Clearance business.industry Inulin clearance Creatinine clearance chemistry Creatinine Original Article business Glomerular Filtration Rate |
| Zdroj: | Clinical and Experimental Nephrology |
| ISSN: | 1437-7799 1342-1751 |
| Popis: | Background There is no approved dosage and administration of inulin for children. Therefore, we measured inulin clearance (Cin) in pediatric patients with renal disease using the pediatric dosage and administration formulated by the Japanese Society for Pediatric Nephrology, and compared Cin with creatinine clearance (Ccr) measured at the same time. We examined to what degree Ccr overestimates Cin, using the clearance ratio (Ccr/Cin), and confirmed the safety of inulin in pediatric patients. Methods Pediatric renal disease patients aged 18 years or younger were enrolled. Inulin (1.0 g/dL) was administered intravenously at a priming rate of 8 mL/kg/hr (max 300 mL/hr) for 30 min. Next, patients received inulin at a maintenance rate of 0.7 × eGFR mL/min/1.73 m2 × body surface area (max 100 mL/hr) for 120 min. With the time the maintenance rate was initiated as a starting point, blood was collected at 30 and 90 min, while urine was collected twice at 60-min intervals. The primary endpoint was the ratio of Ccr to Cin (Ccr/Cin). Results Inulin was administered to 60 pediatric patients with renal disease; 1 patient was discontinued and 59 completed. The primary endpoint, Ccr/Cin, was 1.78 ± 0.52 (mean ± standard deviation). Regarding safety, five adverse events were observed in four patients (6.7%); all were non-serious. No adverse reactions were observed in this study. Conclusions The results in this study on the dosage and administration of inulin showed that inulin can safely and accurately determine GFR in pediatric patients with renal disease. ClinicalTrials.gov identifier NCT03345316. |
| Databáze: | OpenAIRE |
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