Pharmacology of Aminophylline for Acute Kidney Injury in... | NCT02276170

Studies
Pharmacology of Aminophylline for Acute Kidney Injury in Neonates

NCT02276170

Sponsor

Stanford University

Status

Terminated

Last Update Posted

Sep 19, 2019Actual

Enrollment

9Actual

Phase

Not provided

Conditions

Acute Kidney Injury

Interventions

Not provided

Countries

United States

Protocol Section

Identification Module Status Module Sponsor/Collaborators Module Oversight Module Description Module Conditions Module Design Module Arms/Interventions Module Outcomes Module Eligibility Module Contacts/Locations Module References Module IPD Sharing Statement Module

Results Section

Participant Flow Module Baseline Characteristics Module Outcome Measures Module Adverse Events Module More Info Module

Annotation Section

Annotation Module

Document Section

Large Document Module

Derived Section

Miscellaneous Info Module Condition Browse Module Intervention Browse Module

Protocol Section

Identification Module

NCT ID

Results Section

No data available

No data is available for this block.

Annotation Section

No data available

No data is available for this block.

Document Section

No data available

No data is available for this block.

Derived Section

Miscellaneous Info Module

Version Holder

Status Module

Record Verification Date

Sep 2019

Overall Recruitment Status or Expanded Access Status

Terminated

Last Known Status

Not provided

Delayed Posting

Not provided

Why Stopped

insufficient rate of accrual

Expanded Access Info

Start Date

Oct 2014Actual

Primary Completion Date

Aug 2018Actual

Completion Date

Aug 2018Actual

First Submitted Date

Oct 21, 2014

First Submission Date that Met QC Criteria

Oct 23, 2014

First Posted Date

Oct 28, 2014Estimated

Results Waived

Not provided

Results First Submitted Date

Not provided

Results First Submitted that Met QC Criteria

Not provided

Results First Posted Date

Not provided

Certification/Extension (aka Delayed Results) First Submitted Date

Not provided

Certification/Extension First Submitted that Passed QC Review

Not provided

Certification/Extension First Posted Date

Not provided

Last Update Submitted Date

Sep 17, 2019

Last Update Posted Date

Sep 19, 2019Actual

Sponsor/Collaborators Module

Responsible Party, by Official Title

Adam R Frymoyer, Clinical Assistant Professor, Stanford UniversityPrincipal Investigator

Lead Sponsor

Stanford UniversityOTHER

Collaborators

Name	Class
Eunice Kennedy Shriver National Institute of Child Health and Human Development (NICHD)	NIH

Oversight Module

Has Data Monitoring Committee (DMC)

Is FDA Regulated Drug

Not provided

Is FDA Regulated Device

Not provided

Is Unapproved Device

Not provided

Pediatric Postmarket Surveillance of a Device Product

Not provided

Product Exported from US

Not provided

FDAAA801 Violation

Not provided

Description Module

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.

Detailed Description

Not provided

Design Module

Study Type

Observational

Number of References to an Expanded Access Study

Not provided

Expanded Access Types

Not provided

Patient Registry

Target Follow-Up Duration

Not provided

Phases

Not provided

Interventional Study Design

Allocation

Not provided

Intervention Model

Biospecimen

No data available

No data is available for this block.

Enrollment

9Actual

Label	Type	Description	Intervention Names
Aminophylline per standard of care

Outcomes Module

Primary Outcomes

Measure	Description	Time Frame
Drug concentrations of theophylline		Day 1 or 2 and Day 3,4, or 5

Secondary Outcomes

Measure	Description	Time Frame
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

Other Outcomes

Not provided

Eligibility Module

Eligibility Criteria

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).

Accepts Healthy Volunteers

Sex

All

Sex/Gender Based

Not provided

Sex/Gender Description

Not provided

Minimum Age

Not provided

Maximum Age

3 Months

Standard Ages

Child

Study Population

Neonates with AKI admitted in the NICU who receive aminophylline.

Sampling Method

Non-Probability Sample

Contacts/Locations Module

Central Contacts

Not provided

Overall Officials

Name	Affiliation	Role
Adam Frymoyer, MD	Stanford University	Principal Investigator

Locations

Facility	Status	City	State	ZIP	Country	Contacts
Lucile Packard Children's Hospital Stanford		Palo Alto	California	94305-5208	United States

References Module

Citations

PubMed Identifier	Type	Citation	Retractions
3153295	Background	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.
15354981	Background	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.

ID	Term
D051437	Renal Insufficiency
D007674	Kidney Diseases
D014570	Urologic Diseases
D052776	Female Urogenital Diseases