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Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

Information source: Stanford University
ClinicalTrials.gov processed this data on August 23, 2015
Link to the current ClinicalTrials.gov record.

Condition(s) targeted: Acute Kidney Injury

Phase: N/A

Status: Enrolling by invitation

Sponsored by: Stanford University

Official(s) and/or principal investigator(s):
Adam Frymoyer, MD, Principal Investigator, Affiliation: Stanford University


Acute kidney injury (AKI) in critically ill neonates is common and associated with significant morbidity and mortality. No targeted therapeutic treatment strategies have been established for AKI in neonates. Within a clinical pharmacokinetic and pharmacodynamic conceptual framework, this project will examine the medication aminophylline as a potential treatment approach for AKI.

Clinical Details

Study design: Observational Model: Cohort, Time Perspective: Prospective

Primary outcome: Drug concentrations of theophylline

Secondary outcome:

Change in renal Near-infrared spectroscopy (NIRS)

Change in urine output

Number of participants with adverse events

Change in urine biomarker levels

Change in serum creatinine level


Minimum age: N/A. Maximum age: 3 Months. Gender(s): Both.


Inclusion Criteria:

- Neonate < 3 months post natal age

- Diagnosed with acute kidney injury (AKI)

- Receiving aminophylline for AKI treatment as per local standard of care.

Exclusion Criteria:

- Presence of anatomical renal anomaly based on postnatal evaluation of the patient

(hydronephrosis, multicystic kidney, renal agenesis, renal dysplasia, polycystic kidney, or obstructive uropathy)

- Patient on renal replacement therapy

- Major genetic abnormalities (trisomy 13, 18 or 21).

Locations and Contacts

Lucile Packard Children's Hospital Stanford, Palo Alto, California 94305-5208, United States
Additional Information

Related publications:

Stapleton FB, Jones DP, Green RS. Acute renal failure in neonates: incidence, etiology and outcome. Pediatr Nephrol. 1987 Jul;1(3):314-20. Review.

Agras PI, Tarcan A, Baskin E, Cengiz N, G├╝rakan B, Saatci U. Acute renal failure in the neonatal period. Ren Fail. 2004 May;26(3):305-9.

Koralkar R, Ambalavanan N, Levitan EB, McGwin G, Goldstein S, Askenazi D. Acute kidney injury reduces survival in very low birth weight infants. Pediatr Res. 2011 Apr;69(4):354-8. doi: 10.1203/PDR.0b013e31820b95ca.

Askenazi DJ, Ambalavanan N, Goldstein SL. Acute kidney injury in critically ill newborns: what do we know? What do we need to learn? Pediatr Nephrol. 2009 Feb;24(2):265-74. doi: 10.1007/s00467-008-1060-2. Epub 2008 Dec 10. Review.

Andreoli SP. Acute kidney injury in children. Pediatr Nephrol. 2009 Feb;24(2):253-63. doi: 10.1007/s00467-008-1074-9. Epub 2008 Dec 13. Review.

Mishra J, Dent C, Tarabishi R, Mitsnefes MM, Ma Q, Kelly C, Ruff SM, Zahedi K, Shao M, Bean J, Mori K, Barasch J, Devarajan P. Neutrophil gelatinase-associated lipocalin (NGAL) as a biomarker for acute renal injury after cardiac surgery. Lancet. 2005 Apr 2-8;365(9466):1231-8.

Bennett M, Dent CL, Ma Q, Dastrala S, Grenier F, Workman R, Syed H, Ali S, Barasch J, Devarajan P. Urine NGAL predicts severity of acute kidney injury after cardiac surgery: a prospective study. Clin J Am Soc Nephrol. 2008 May;3(3):665-73. doi: 10.2215/CJN.04010907. Epub 2008 Mar 12.

Askenazi DJ, Griffin R, McGwin G, Carlo W, Ambalavanan N. Acute kidney injury is independently associated with mortality in very low birthweight infants: a matched case-control analysis. Pediatr Nephrol. 2009 May;24(5):991-7. doi: 10.1007/s00467-009-1133-x. Epub 2009 Feb 24.

Mangione F, Calcaterra V, Esposito C, Dal Canton A. Renal blood flow redistribution during acute kidney injury. Am J Kidney Dis. 2010 Oct;56(4):785-7. doi: 10.1053/j.ajkd.2010.03.035. Epub 2010 Jun 26.

Voors AA, Dittrich HC, Massie BM, DeLucca P, Mansoor GA, Metra M, Cotter G, Weatherley BD, Ponikowski P, Teerlink JR, Cleland JG, O'Connor CM, Givertz MM. Effects of the adenosine A1 receptor antagonist rolofylline on renal function in patients with acute heart failure and renal dysfunction: results from PROTECT (Placebo-Controlled Randomized Study of the Selective Adenosine A1 Receptor Antagonist Rolofylline for Patients Hospitalized with Acute Decompensated Heart Failure and Volume Overload to Assess Treatment Effect on Congestion and Renal Function). J Am Coll Cardiol. 2011 May 10;57(19):1899-907. doi: 10.1016/j.jacc.2010.11.057.

Lee HT, Xu H, Nasr SH, Schnermann J, Emala CW. A1 adenosine receptor knockout mice exhibit increased renal injury following ischemia and reperfusion. Am J Physiol Renal Physiol. 2004 Feb;286(2):F298-306. Epub 2003 Nov 4.

Jenik AG, Ceriani Cernadas JM, Gorenstein A, Ramirez JA, Vain N, Armadans M, Ferraris JR. A randomized, double-blind, placebo-controlled trial of the effects of prophylactic theophylline on renal function in term neonates with perinatal asphyxia. Pediatrics. 2000 Apr;105(4):E45.

Bakr AF. Prophylactic theophylline to prevent renal dysfunction in newborns exposed to perinatal asphyxia--a study in a developing country. Pediatr Nephrol. 2005 Sep;20(9):1249-52. Epub 2005 Jun 10.

Bhat MA, Shah ZA, Makhdoomi MS, Mufti MH. Theophylline for renal function in term neonates with perinatal asphyxia: a randomized, placebo-controlled trial. J Pediatr. 2006 Aug;149(2):180-4.

Starting date: October 2014
Last updated: October 23, 2014

Page last updated: August 23, 2015

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