Clinical Trial: Efficacy of Pentoxifylline on Primary Nephrotic Syndrome

Study Status: Completed
Recruit Status: Completed
Study Type: Interventional

Official Title: Clinical Efficacy of Pentoxifylline on Patients With Primary Nephrotic Syndrome

Brief Summary: We aim to investigate (1) the effects of combined pentoxifylline and corticosteroids, compared to that of corticosteroids, on patients with primary nephrotic syndrome; and if possible (2) the effects of pentoxifylline monotherapy on patients with primary nephrotic syndrome not suitable for or intolerant of standard corticosteroid therapy.

Detailed Summary:

Pentoxifylline (PTX) is a phosphodiesterase inhibitor that is used clinically to treat patients with peripheral vascular disorders. In addition to its hemorheologic activity, PTX possesses potent anti-inflammatory and immunomodulatory properties. In vivo, PTX has shown its ability to attenuate nephrotic syndrome secondary to membranous glomerulonephritis and lupus nephritis, and to reduce subnephrotic proteinuria of early and advanced diabetic nephropathy. However, the anti-proteinuric effect of PTX has been traditionally attributed to down-regulation of tumor necrosis factor (TNF)-alpha. Whether or not other inflammatory mediators are also affected by PTX has never been studied. Our previous works have shown that PTX can inhibit cytokine or albumin-induced monocyte chemoattractant protein (MCP)-1 production in vitro, and attenuate proteinuria in association with suppression of renal MCP-1 messenger ribonucleic acid expression in experimental glomerulonephritis. More recently, we have found that PTX lowers proteinuria by modulating renal MCP-1 production in a subgroup of human glomerular diseases. In this study, we aim to investigate whether combination of PTX and corticosteroids results in additive reduction in proteinuria, and higher remission rates in patients with primary nephrotic syndrome. The secondary objective is to study whether PTX monotherapy can be effective in patients with primary nephrotic syndrome not suitable for or intolerant of corticosteroid therapy.

This study is a prospective, open-labeled, comparative study including primary nephrotic patients randomized into 2 groups. Group A receives oral PTX plus oral prednisolone, whereas group B receives oral prednisolone alone. The active treatment duration is 1 year for both subgroups. The dose for PTX will be 1,200 mg/day (for estimated glomerular filtration rate (GFR) ≧60 ml/min) or 800 mg/day (estim
Sponsor: National Taiwan University Hospital

Current Primary Outcome: changes from baseline in urinary protein excretion [ Time Frame: 18 months ]

Original Primary Outcome: changes from baseline in urinary protein excretion

Current Secondary Outcome: change from baseline in creatinine and estimated GFR [ Time Frame: 18 months ]

Original Secondary Outcome: change from baseline in serum CRP, creatinine and estimated creatinine clearance, as well as urinary NAG, TNF-alpha and MCP-1

Information By: National Taiwan University Hospital

Dates:
Date Received: July 18, 2006
Date Started: August 2006
Date Completion:
Last Updated: November 12, 2012
Last Verified: October 2012