Universität zu Köln

Hoppe, Bernd, Groothoff, Jaap W., Hulton, Sally-Anne, Cochat, Pierre, Niaudet, Patrick, Kemper, Markus J., Deschenes, George, Unwin, Robert and Milliner, Dawn (2011). Efficacy and safety of Oxalobacter formigenes to reduce urinary oxalate in primary hyperoxaluria. Nephrol. Dial. Transplant., 26 (11). S. 3609 - 3617. OXFORD: OXFORD UNIV PRESS. ISSN 0931-0509

Full text not available from this repository.

Abstract

Background. Primary hyperoxaluria (PH) is a rare genetic disease, in which high urinary oxalate (Uox) cause recurrent kidney stones and/or progressive nephrocalcinosis, often followed by early end-stage renal disease, as well as extremely high plasma oxalate, systemic oxalosis and premature death. Oxalobacter formigenes, an anaerobic oxalate degrading bacterium, naturally colonizes the colon of most humans. Orally administered O. formigenes (Oxabact) was found to significantly reduce urine and plasma oxalate. We aimed to evaluate its effect and safety in a randomized, double-blind, placebo-controlled multicenter study. Methods. Oral Oxabact was given to PH patients (> 5 years old, Uox > 1.0 mmol/1.73m(2)/day, glomerular filtration rate (GFR) > 50 mL/min) at nine PH referral sites worldwide. Primary endpoint was the change from baseline in Uox (mmol/1.73m(2)/day) after 24 weeks of treatment (> 20% reduction). Results. Of the 43 subjects randomized, 42 patients received either placebo (23 subjects) or Oxabact (19 subjects). The change in Uox was < 20% and not different between groups (P = 0.616). Ad hoc analysis was performed in 37 patients compliant with medication and urine processing. Change in Uox was -19% in subjects given Oxabact and -10% in placebo, (P = 0.288), but -21 and -7% with Uox expressed as molar creatinine ratio (Ox:Cr, mmol/mol, P = 0.06). Reduction of Ox: Cr was more obvious for patients with higher baseline values (> 160 mmol/mol, Oxabact -28%, placebo -6%; P < 0.082). No serious adverse events were reported. Conclusion. Oxabact was safe and well tolerated. However, as no significant change in Uox was seen, further studies to evaluate the efficacy of Oxabact treatment are needed.

Item Type:	Journal Article
Creators:	Creators Email ORCID ORCID Put Code Hoppe, Bernd UNSPECIFIED UNSPECIFIED UNSPECIFIED Groothoff, Jaap W. UNSPECIFIED UNSPECIFIED UNSPECIFIED Hulton, Sally-Anne UNSPECIFIED UNSPECIFIED UNSPECIFIED Cochat, Pierre UNSPECIFIED UNSPECIFIED UNSPECIFIED Niaudet, Patrick UNSPECIFIED UNSPECIFIED UNSPECIFIED Kemper, Markus J. UNSPECIFIED UNSPECIFIED UNSPECIFIED Deschenes, George UNSPECIFIED UNSPECIFIED UNSPECIFIED Unwin, Robert UNSPECIFIED UNSPECIFIED UNSPECIFIED Milliner, Dawn UNSPECIFIED UNSPECIFIED UNSPECIFIED
URN:	urn:nbn:de:hbz:38-486342
DOI:	10.1093/ndt/gfr107
Journal or Publication Title:	Nephrol. Dial. Transplant.
Volume:	26
Number:	11
Page Range:	S. 3609 - 3617
Date:	2011
Publisher:	OXFORD UNIV PRESS
Place of Publication:	OXFORD
ISSN:	0931-0509
Language:	English
Faculty:	Unspecified
Divisions:	Unspecified
Subjects:	no entry
Uncontrolled Keywords:	Keywords Language GLOMERULAR-FILTRATION-RATE; GASTROINTESTINAL-TRACT; PLASMA OXALATE; CREATININE; PYRIDOXINE; EXCRETION; TYPE-1; ENZYME; COLONIZATION; TRANSPORT Multiple languages Transplantation; Urology & Nephrology Multiple languages
URI:	http://kups.ub.uni-koeln.de/id/eprint/48634