Perioperative Aminophylline to Improve Early Kidney Function After a Kidney Transplant

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.

Timeline

Start

2012-11

Primary completion

2017-01-05

Completion

2017-07-25

Outcome

Missed primary endpoint

registry analysis (superiority test); Aminophylline vs Control; p = 0.32; t-test, 2 sided NCT01759862 ↗

Publications

• Background 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.
• 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.
• 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.
• 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.

Drugs

Indications

No indication recorded.