Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant

NCT01759862 | Completed Results DMC

• 1 other identifier: 24280
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Function of Renal Transplant

Keywords

kidney transplant; Aminophylline; pediatric

Outcome Measures

Primary Outcomes (1)

• Calculated Estimated Glomerular Filtration Rate (eGFR)

  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.

  5 days

Secondary Outcomes (1)

• Urinary NGAL (Neutrophil Gelatinase-associated Lipocalin)/ Creatinine Ratio

  12 hours post transplant

Other Outcomes (1)

• Presence of Fibrosis Measured on Protocol Biopsy

  6 months

Study Arms (2)

Aminophylline

EXPERIMENTAL

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; Other: Theophylline drug levels

Control

PLACEBO COMPARATOR

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; Drug: Placebo

Interventions

Aminophylline DRUG

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

Also known as: Theophylline

Aminophylline

Theophylline drug levels OTHER

Theophylline drug levels will be monitored every morning from all patients for the first 4 days post- transplant.

Aminophylline; Control

Placebo DRUG

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.

Also known as: Normal saline

Control

Eligibility Criteria

• Age: 1 Year - 21 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Child (0-17), Adult (18-64)

You may qualify if:

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

You may not qualify if:

• Known history of non-sinus tachycardia
• Multiple organ transplants recipients
• Severe liver dysfunction
• graft was placed on pump after harvesting

Sponsors & Collaborators

• Stanford University: lead

Study Sites (1)

Lucile Packard Children's Hospital at Stanford

Stanford, California, 94305-5208, United States

Location

Related Publications (4)

• Grenz A, Baier D, Petroktistis F, Wehrmann M, Kohle C, Schenk M, Sessler M, Gleiter CH, Fandrich F, Osswald H. Theophylline improves early allograft function in rat kidney transplantation. J Pharmacol Exp Ther. 2006 May;317(2):473-9. doi: 10.1124/jpet.105.096917. Epub 2006 Jan 12.

  PMID: 16410406 BACKGROUND

• 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: 16887430 BACKGROUND

• 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: 10742366 BACKGROUND

• McLaughlin GE, Abitbol CL. Reversal of oliguric tacrolimus nephrotoxicity in children. Nephrol Dial Transplant. 2005 Jul;20(7):1471-5. doi: 10.1093/ndt/gfh785. Epub 2005 Apr 19.

  PMID: 15840666 BACKGROUND

MeSH Terms

Interventions

Aminophylline; Theophylline; Saline Solution

Intervention Hierarchy (Ancestors)

Ethylenediamines; Diamines; Polyamines; Amines; Organic Chemicals; Xanthines; Purinones; Purines; Heterocyclic Compounds, 2-Ring; Heterocyclic Compounds, Fused-Ring; Heterocyclic Compounds; Drug Combinations; Pharmaceutical Preparations; Alkaloids; Crystalloid Solutions; Isotonic Solutions; Solutions

Limitations and Caveats

Small sample size

Results Point of Contact

• Title: Paul Grimm
• Organization: Stanford University

6507237903

Study Officials

• Paul C Grimm, MD

  Medical director, Pediatric Kidney Transplant Program Department of Pediatric Nephrology , Lucile Packard Children's hospital

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: Yes

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Pediatric Nephrology

Study Record Dates

• First Submitted: December 30, 2012
• First Posted: January 3, 2013
• Study Start: November 1, 2012
• Primary Completion: January 5, 2017
• Study Completion: July 25, 2017
• Last Updated: March 5, 2019
• Results First Posted: March 5, 2019

Record last verified: 2019-02

Locations

US (1)