NCT02276170

Brief Summary

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.

Trial Health

57
Monitor

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
9

participants targeted

Target at below P25 for all trials

Timeline
Completed

Started Oct 2014

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
terminated

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

October 1, 2014

Completed
20 days until next milestone

First Submitted

Initial submission to the registry

October 21, 2014

Completed
7 days until next milestone

First Posted

Study publicly available on registry

October 28, 2014

Completed
3.8 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 1, 2018

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 1, 2018

Completed
Last Updated

September 19, 2019

Status Verified

September 1, 2019

Enrollment Period

3.8 years

First QC Date

October 21, 2014

Last Update Submit

September 17, 2019

Conditions

Acute Kidney Injury

Outcome Measures

Primary Outcomes (1)

  • Drug concentrations of theophylline

    Day 1 or 2 and Day 3,4, or 5

Secondary Outcomes (5)

  • Change in renal Near-infrared spectroscopy (NIRS)

    Day 1,2,3,4

  • Change in urine output

    Day 1,2,3,4

  • Number of participants with adverse events

    5 days

  • Change in urine biomarker levels

    Day 1,2,3,4,5

  • Change in serum creatinine level

    Day 1,2,3,4,5

Study Arms (1)

Aminophylline per standard of care

Eligibility Criteria

AgeUp to 3 Months
Sexall
Healthy VolunteersNo
Age GroupsChild (0-17)
Sampling MethodNon-Probability Sample
Study Population

Neonates with AKI admitted in the NICU who receive aminophylline.

You may qualify if:

  • Neonate \< 3 months post natal age
  • Diagnosed with acute kidney injury (AKI)
  • Receiving aminophylline for AKI treatment as per local standard of care.

You may not qualify if:

  • 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).

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Lucile Packard Children's Hospital Stanford

Palo Alto, California, 94305-5208, United States

Location

Related Publications (14)

  • Stapleton FB, Jones DP, Green RS. Acute renal failure in neonates: incidence, etiology and outcome. Pediatr Nephrol. 1987 Jul;1(3):314-20. doi: 10.1007/BF00849230.

    PMID: 3153295BACKGROUND

  • Agras PI, Tarcan A, Baskin E, Cengiz N, Gurakan B, Saatci U. Acute renal failure in the neonatal period. Ren Fail. 2004 May;26(3):305-9. doi: 10.1081/jdi-200026749.

    PMID: 15354981BACKGROUND

  • 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.

    PMID: 21178824BACKGROUND

  • 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.

    PMID: 19082634BACKGROUND

  • 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.

    PMID: 19083019BACKGROUND

  • 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. doi: 10.1016/S0140-6736(05)74811-X.

    PMID: 15811456BACKGROUND

  • 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.

    PMID: 18337554BACKGROUND

  • 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.

    PMID: 19238451BACKGROUND

  • 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.

    PMID: 20580475BACKGROUND

  • 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.

    PMID: 21545947BACKGROUND

  • 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. doi: 10.1152/ajprenal.00185.2003. Epub 2003 Nov 4.

    PMID: 14600029BACKGROUND

  • 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. doi: 10.1542/peds.105.4.e45.

    PMID: 10742366BACKGROUND

  • 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. doi: 10.1007/s00467-005-1980-z. Epub 2005 Jun 10.

    PMID: 15947981BACKGROUND

  • 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. doi: 10.1016/j.jpeds.2006.03.053.

    PMID: 16887430BACKGROUND

MeSH Terms

Conditions

Acute Kidney Injury

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital Diseases

Study Officials

  • Adam Frymoyer, MD

    Stanford University

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Clinical Assistant Professor

Study Record Dates

First Submitted

October 21, 2014

First Posted

October 28, 2014

Study Start

October 1, 2014

Primary Completion

August 1, 2018

Study Completion

August 1, 2018

Last Updated

September 19, 2019

Record last verified: 2019-09

Locations

US(1)