Ignite Creation Date:
2024-05-05 @ 4:57 PM
Last Modification Date:
2024-10-26 @ 9:26 AM
Study NCT ID:
NCT00354731
Status:
COMPLETED
Last Update Posted:
2012-11-14
First Post:
2006-07-18
Brief Title:
Efficacy of Pentoxifylline on Primary Nephrotic Syndrome
Sponsor:
National Taiwan University Hospital
Organization:
National Taiwan University Hospital
Study Overview
Official Title:
Clinical Efficacy of Pentoxifylline on Patients With Primary Nephrotic Syndrome
Status:
COMPLETED
Status Verified Date:
2012-10
Last Known Status:
None
Delayed Posting:
No
If Stopped, Why?:
Not Stopped
Has Expanded Access:
False
If Expanded Access, NCT#:
N/A
Has Expanded Access, NCT# Status:
N/A
Acronym:
None
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 Description:
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 1200 mgday for estimated glomerular filtration rate GFR 60 mlmin or 800 mgday estimated GFR 59-30 mlmin x 6 months followed by stepwise reduction 800 mgday x 6 M 400 mgday x 6 M and discontinued at 18 M The dose for prednisolone will be 1 mgkgday for the initial 3 months then the dose will be gradually tapered thus by 6 months the dose will be 05 mgkgday and at 12 months the dose will be reduced to around 5-10 mgday and discontinued at 18 M For patients not considered suitable for eg active chronic hepatitis B virus or hepatitis C virus infection or intolerance of eg concomitant diabetes mellitus active peptic ulcer disease standard corticosteroid therapy PTX 1200 mgday will be administered to them for a total of 1 year Serum and urine specimens will be collected before initiation of therapy day 0 and at month 1 3 6 and 12 after the commencement of therapy GFR will be calculated by Cockcroft-Gault and simplified Modification of Diet in Renal Disease MDRD formula Urinary protein excretion will be quantitated by spot urine proteincreatinine ratio All biochemical and immunological analyses will be performed by the Department of Laboratory Medicine National Taiwan University Hospital Serum and urine samples will be measured for inflammatory mediators and podocyte markers by using commercial ELISA kits
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 1200 mgday for estimated glomerular filtration rate GFR 60 mlmin or 800 mgday estimated GFR 59-30 mlmin x 6 months followed by stepwise reduction 800 mgday x 6 M 400 mgday x 6 M and discontinued at 18 M The dose for prednisolone will be 1 mgkgday for the initial 3 months then the dose will be gradually tapered thus by 6 months the dose will be 05 mgkgday and at 12 months the dose will be reduced to around 5-10 mgday and discontinued at 18 M For patients not considered suitable for eg active chronic hepatitis B virus or hepatitis C virus infection or intolerance of eg concomitant diabetes mellitus active peptic ulcer disease standard corticosteroid therapy PTX 1200 mgday will be administered to them for a total of 1 year Serum and urine specimens will be collected before initiation of therapy day 0 and at month 1 3 6 and 12 after the commencement of therapy GFR will be calculated by Cockcroft-Gault and simplified Modification of Diet in Renal Disease MDRD formula Urinary protein excretion will be quantitated by spot urine proteincreatinine ratio All biochemical and immunological analyses will be performed by the Department of Laboratory Medicine National Taiwan University Hospital Serum and urine samples will be measured for inflammatory mediators and podocyte markers by using commercial ELISA kits
Study Oversight
Has Oversight DMC:
None
Is a FDA Regulated Drug?:
None
Is a FDA Regulated Device?:
None
Is an Unapproved Device?:
None
Is a PPSD?:
None
Is a US Export?:
None
Is an FDA AA801 Violation?:
None