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Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant (RTphylline)

This study is currently recruiting participants.
Verified March 2013 by Stanford University
Sponsor:
Information provided by (Responsible Party):
Stanford University
ClinicalTrials.gov Identifier:
NCT01759862
First received: December 30, 2012
Last updated: March 19, 2013
Last verified: March 2013
History of Changes
  Purpose

The aim of this study is to evaluate whether peri-transplant administration of a drug named aminophylline to children undergoing a kidney transplant from deceased donors improves early graft function and also projects on long term graft function.


Condition Intervention
Function of Renal Transplant
 Drug: Aminophylline
Other: Theophylline drug levels
Drug: Placebo

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Safety/Efficacy Study
Intervention Model: Parallel Assignment
Masking: Double Blind (Subject, Caregiver, Investigator)
Primary Purpose: Treatment
Official Title: Perioperative Aminophylline to Improve High Risk Renal Graft Outcome- a Double Blinded, Placebo Controlled, Randomized Clinical Trial

Resource links provided by NLM:

U.S. FDA Resources

Further study details as provided by Stanford University:

Primary Outcome Measures:
  • Calculated estimated Glomerular Filtration rate (eGFR) [ Time Frame: 5 days ] [ Designated as safety issue: No ]
    The investigators will measure blood creatinine on post-operative day 5 and using the Schwartz equation will calculate estimated glomerular filtration rate (GFR) to determine kidney function.


Secondary Outcome Measures:
  • Urinary NGAL (Neutrophil gelatinase-associated lipocalin) levels [ Time Frame: 12 hours post transplant ] [ Designated as safety issue: No ]
    urinary NGAL(Neutrophil gelatinase-associated lipocalin) is a biomarker for kidney injury. NGAL levels 12h post-transplant were found to be a marker for development of delayed graft function and need for dialysis post-transplant.


Other Outcome Measures:
  • Degree of fibrosis measured on protocol biopsy [ Time Frame: 6 months ] [ Designated as safety issue: No ]
    The investigators will use the same cores that are obtained during routine 6 months protocol biopsies to quantify the amount of fibrosis using computerized image analysis of Sirius Red-stained biopsies. The degree of fibrosis at 6 months was found to correlate with graft survival.


Estimated Enrollment: 50
Study Start Date: November 2012
Estimated Study Completion Date: December 2014
Estimated Primary Completion Date: June 2014 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Aminophylline

Patients will receive aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.

Theophylline drug levels will be monitored daily for 4 days.

 Drug: Aminophylline
Aminophylline loading dose 5mg/kg prior to transplant and will continue to receive aminophylline 1.8mg/kg Q6h for a total of 20 doses.
Other Name: Theophylline
Other: Theophylline drug levels
Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant.
Placebo Comparator: Control

Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.

Drug levels will be monitored daily for 4 days.

 Other: Theophylline drug levels
Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant.
Drug: Placebo
Patients will receive placebo infusion of normal saline, pre-transplant, followed by normal saline infusions matched by volume and frequency to treatment arm for a total of 20 doses.
Other Name: Normal saline

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  Eligibility

Ages Eligible for Study:   1 Year to 21 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  1. Pediatric kidney transplant recipients less than 21 years of age
  2. Patients undergoing deceased donor (DD) kidney transplants

Exclusion Criteria:

  1. Known history of non-sinus tachycardia
  2. Multiple organ transplants recipients
  3. Severe liver dysfunction
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01759862

Locations
United States, California
Lucile Packard Children's Hospital at Stanford Recruiting
Stanford, California, United States, 94305-5208
Contact: Orly Haskin, MD     650-723-7903     orlyh@stanford.edu    
Contact: Paul C Grimm, MD     6507237903     pgrimm@stanford.edu    
Principal Investigator: Orly Haskin, MD            
Sub-Investigator: Paul Grimm, MD            
Sponsors and Collaborators
Stanford University
Investigators
Study Director: Paul C Grimm, MD Medical director, Pediatric Kidney Transplant Program Department of Pediatric Nephrology , Lucile Packard Children's hospital
  More Information

Publications:

Responsible Party: Stanford University
ClinicalTrials.gov Identifier: NCT01759862     History of Changes
Other Study ID Numbers: 24280
Study First Received: December 30, 2012
Last Updated: March 19, 2013
Health Authority: United States: Institutional Review Board

Keywords provided by Stanford University:
kidney transplant
Aminophylline
pediatric

Additional relevant MeSH terms:
Aminophylline
Theophylline
Cardiotonic Agents
Cardiovascular Agents
Therapeutic Uses
Pharmacologic Actions
Phosphodiesterase Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action
Bronchodilator Agents
Autonomic Agents
 Peripheral Nervous System Agents
Physiological Effects of Drugs
Anti-Asthmatic Agents
Respiratory System Agents
Purinergic P1 Receptor Antagonists
Purinergic Antagonists
Purinergic Agents
Neurotransmitter Agents
Protective Agents
Vasodilator Agents

ClinicalTrials.gov processed this record on May 21, 2013