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Prednisone Versus Tamoxifen in Idiopathic Retroperitoneal Fibrosis

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details. Identifier: NCT00440349
Recruitment Status : Unknown
Verified February 2007 by University of Parma.
Recruitment status was:  Active, not recruiting
First Posted : February 27, 2007
Last Update Posted : February 27, 2007
Information provided by:
University of Parma

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.

Condition or disease Intervention/treatment Phase
Retroperitoneal Fibrosis Drug: Tamoxifen Drug: Prednisone Phase 2

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 (e.g. 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 (e.g. drugs, infections, radiotherapy) will be excluded. When present, ureteral obstruction will be managed by ureteral stents/nephrostomy/ureterolysis. All patients will then receive oral prednisone (1 mg/kg/day) for one month, at the end of which they will be randomized to receive either tamoxifen (0.5 mg/kg/day at fixed dose for 8 months) or prednisone (0.5 mg/kg/day for the first month, 0.25 mg/kg/day for the second and third months, and then tapered off during the ensuing 5 months). A CT/MRI 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 (e.g. pain, constitutional symptoms), levels of acute-phase reactants (erythrocyte sedimentation rate, C-reactive protein), and ureteral obstruction (as assessed by sonography or CT/MRI scan).

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Study Type : Interventional  (Clinical Trial)
Enrollment : 38 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: A Randomised Trial of Prednisone and Tamoxifen in Patients With Idiopathic Retroperitoneal Fibrosis
Study Start Date : October 2000
Study Completion Date : April 2007

Primary Outcome Measures :
  1. Difference in recurrence rate at the end of treatment

Secondary Outcome Measures :
  1. Difference in reduction in size of IRF (as assessed by CT/MRI)
  2. Difference in renal function

Information from the National Library of Medicine

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Ages Eligible for Study:   Child, Adult, Older Adult
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

Inclusion Criteria:

  • Diagnosis of idiopathic or perianeurismal retroperitoneal fibrosis

Exclusion Criteria:

  • Previously treated patients; retroperitoneal fibrosis secondary to drugs(e.g. methysergide, methyldopa, pergolide, ergot alkaloids), infections (e.g. tuberculosis), cancer (e.g. lymphoma, sarcoma), radiotherapy, trauma, major surgery, systemic connective tissue or vasculitis disease (e.g. SLE, panarteritis nodosa); pregnancy; active infections or tumours; known hypersensitivity to prednisone or tamoxifen; uncontrolled diabetes.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its identifier (NCT number): NCT00440349

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Department of Clinical Medicine Nephrology and Health Science, Parma University Hospital
Parma, Italy, 43100
Sponsors and Collaborators
University of Parma
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Principal Investigator: Carlo Buzio, MD University of Parma

Publications automatically indexed to this study by Identifier (NCT Number):
Layout table for additonal information Identifier: NCT00440349    
Other Study ID Numbers: FR09
First Posted: February 27, 2007    Key Record Dates
Last Update Posted: February 27, 2007
Last Verified: February 2007
Keywords provided by University of Parma:
Retroperitoneal fibrosis
Obstructive uropathy
Periaortic fibrosis
Chronic periaortitis
Additional relevant MeSH terms:
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Retroperitoneal Fibrosis
Pathologic Processes
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Estrogen Antagonists
Hormone Antagonists
Selective Estrogen Receptor Modulators
Estrogen Receptor Modulators
Bone Density Conservation Agents