Ignite Creation Date:
2024-05-05 @ 5:23 PM
Last Modification Date:
2024-10-26 @ 9:31 AM
Study NCT ID:
NCT00440349
Status:
UNKNOWN
Last Update Posted:
2007-02-27
First Post:
2007-02-23
Brief Title:
Prednisone Versus Tamoxifen in Idiopathic Retroperitoneal Fibrosis
Sponsor:
University of Parma
Organization:
University of Parma
Study Overview
Official Title:
A Randomised Trial of Prednisone and Tamoxifen in Patients With Idiopathic Retroperitoneal Fibrosis
Status:
UNKNOWN
Status Verified Date:
2007-02
Last Known Status:
ACTIVE_NOT_RECRUITING
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:
Idiopathic retroperitoneal fibrosis IRF is a rare disease characterised by the presence of a retroperitoneal periaortic fibro-inflammatory tissue which may entrap the ureters and cause renal failure The treatment of IRF is not well established Corticosteroids are frequently used but the anti-estrogen agent tamoxifen has also been reported to be effective in a number of reports However no randomised trials have been published so far The aim of the present study is to compare the efficacy of prednisone and tamoxifen in the treatment of IRF
Detailed Description:
Idiopathic retroperitoneal fibrosis IRF is a rare condition hallmarked by the presence of a retroperitoneal mass consisting of chronic inflammatory infiltrate and abundant fibrous tissue IRF usually presents as a systemic inflammatory disease with constitutional symptoms eg fatigue weight loss and high acute-phase reactants in addition IRF patients often complain of abdominal or lumbar pain and if ureteral involvement is present they may also show oliguria and symptoms related to uremia
Ureteral obstructive disease is usually managed by placement of ureteral indwelling stents nephrostomy tubes or in the more severe cases surgical ureterolysis These approaches are usually followed by medical treatment
The medical treatment of IRF is largely empirical corticosteroids are routinely used but a number of reports have shown that tamoxifen may also be effective However no prospective controlled trials have been conducted in patients with this condition In this study we compare the efficacy of prednisone and tamoxifen in IRF patients
Patients who received a diagnosis of IRF will be enrolled while patients with secondary forms of retroperitoneal fibrosis eg drugs infections radiotherapy will be excluded When present ureteral obstruction will be managed by ureteral stentsnephrostomyureterolysis All patients will then receive oral prednisone 1 mgkgday for one month at the end of which they will be randomized to receive either tamoxifen 05 mgkgday at fixed dose for 8 months or prednisone 05 mgkgday for the first month 025 mgkgday for the second and third months and then tapered off during the ensuing 5 months A CTMRI study will be performed before the start of treatment four months after randomization and at the end of treatment All patients will be followed up for at least 18 months after the end of treatment
Disease remission will be defined on the basis of clinical symptoms related to IRF eg pain constitutional symptoms levels of acute-phase reactants erythrocyte sedimentation rate C-reactive protein and ureteral obstruction as assessed by sonography or CTMRI scan
Ureteral obstructive disease is usually managed by placement of ureteral indwelling stents nephrostomy tubes or in the more severe cases surgical ureterolysis These approaches are usually followed by medical treatment
The medical treatment of IRF is largely empirical corticosteroids are routinely used but a number of reports have shown that tamoxifen may also be effective However no prospective controlled trials have been conducted in patients with this condition In this study we compare the efficacy of prednisone and tamoxifen in IRF patients
Patients who received a diagnosis of IRF will be enrolled while patients with secondary forms of retroperitoneal fibrosis eg drugs infections radiotherapy will be excluded When present ureteral obstruction will be managed by ureteral stentsnephrostomyureterolysis All patients will then receive oral prednisone 1 mgkgday for one month at the end of which they will be randomized to receive either tamoxifen 05 mgkgday at fixed dose for 8 months or prednisone 05 mgkgday for the first month 025 mgkgday for the second and third months and then tapered off during the ensuing 5 months A CTMRI study will be performed before the start of treatment four months after randomization and at the end of treatment All patients will be followed up for at least 18 months after the end of treatment
Disease remission will be defined on the basis of clinical symptoms related to IRF eg pain constitutional symptoms levels of acute-phase reactants erythrocyte sedimentation rate C-reactive protein and ureteral obstruction as assessed by sonography or CTMRI scan
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