- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT04762810
A Prospective Study of Cyclophosphamide Treatment for Idiopathic Retroperitoneal Fibrosis (IRPF)
A Prospective Study to Evaluate the Efficacy and Safety of Cyclophosphamide in the Treatment of Idiopathic Retroperitoneal Fibrosis
Study Overview
Status
Conditions
Intervention / Treatment
Detailed Description
Idiopathic retroperitoneal fibrosis is a chronic disease that requires treatment for a few years. Patients with this disease respond well to glucocorticoid therapy, so you need to take glucocorticoid medication once the diagnosis is established. In addition, most patients need to use immunosuppressants when taking glucocorticoids. At present, the most commonly used immunosuppressants in the world are cyclophosphamide, azathioprine, methotrexate and mycophoranate, etc. The function of the above drugs is to improve the disorder of the immune system function, in order to restore the normal immune state, so that the inflammation and swelling of the affected organs disappear, restore the normal function. It should be emphasized that if the use of hormones and immunosuppressant is not standard or stopped too early, it can lead to disease recurrence. Therefore, after the disease is under control, long-term adherence to medication is needed to maintain a stable state of the disease.
At present, there is no clear treatment guideline for idiopathic retroperitoneal fibrosis in the world, and the addition of immunosuppressant is also out of debate. Therefore, a comprehensive evaluation of its pathogenesis, clinical characteristics and treatment response is needed.
Study Type
Enrollment (Anticipated)
Phase
- Phase 4
Contacts and Locations
Study Locations
-
-
Beijing
-
Beijing, Beijing, China, 100032
- Recruiting
- Peking Union Medical College Hospital
-
Contact:
- Yunyun Fei
- Phone Number: +8613681125226
- Email: feiyunyun2013@sina.com
-
-
Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- age 18-75 diagnosed as IRPF. The diagnosis of idiopathic retroperitoneal fibrosis is based on the following aspects :(1) the swelling of retroperitoneal tissue , which seems neoplastic; (2) A large number of lymphocytes proliferated and infiltrated in the affected tissues and organs, and tissues showed inflammation, fibrosis and sclerosis, in which IgG4-positive cells accounted for less than 50% of plasma cells; (3) Increased inflammatory markers, such as ESR and CRP; (4) Good response to glucocorticoid therapy.
Exclusion Criteria:
- malignancy retroperitoneal fibrosis secondary to other diseases or drugs or abdominal surgeries.
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: Cyclophosphamide and Glucocorticoids
Through the selective depletion of proliferating lymphocytes, cyclophosphamide has an inhibitory effect on both humoral and cellular immunity.
Cyclophosphamide 50mg per day for 6 months and decrease to 50mg Qod for 6 months.
|
Prednisone/prednisolone: started at 0.6-0.
8mg/kg.d
for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months.
Cyclophosphamide 50mg per day for 6 months and decrease to 50mg Qod for 6 months.
|
Active Comparator: Glucocorticoids monotherapy
Prednisone/prednisolone: started at 0.6-0.
8mg/kg.d
for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months.
|
Steroids have fast onset of action and multiple anti-inflammatory effects.
Prednisone/prednisolone: started at 0.6-0.
8mg/kg.d
for 2 to 4 weeks, tapered at 5mg per 1-2 weeks before 15mg per day, and tapered at 2.5-5mg per 2 weeks to equal to or less than 5mg per day in 6 months.
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
remission
Time Frame: 5 years
|
Patients achieve remission in symptoms and laboratory tets or radiologic images and have a low diseae activity after treatment.
|
5 years
|
Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
relapse
Time Frame: 5 years
|
Patients have a recurrence of symptoms or laboratory abnormalities and have a considerable diseae activity after achieving remission.
|
5 years
|
Other Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
adverse events
Time Frame: 5 years
|
Patients have adverse events due to the drug treatment.
|
5 years
|
Collaborators and Investigators
Publications and helpful links
General Publications
- Vaglio A, Salvarani C, Buzio C. Retroperitoneal fibrosis. Lancet. 2006 Jan 21;367(9506):241-51. doi: 10.1016/S0140-6736(06)68035-5.
- Marzano A, Trapani A, Leone N, Actis GC, Rizzetto M. Treatment of idiopathic retroperitoneal fibrosis using cyclosporin. Ann Rheum Dis. 2001 Apr;60(4):427-8. doi: 10.1136/ard.60.4.427.
- Jagadesham VP, Scott DJ, Carding SR. Abdominal aortic aneurysms: an autoimmune disease? Trends Mol Med. 2008 Dec;14(12):522-9. doi: 10.1016/j.molmed.2008.09.008. Epub 2008 Nov 6.
- Qian Q, Kashani KB, Miller DV. Ruptured abdominal aortic aneurysm related to IgG4 periaortitis. N Engl J Med. 2009 Sep 10;361(11):1121-3. doi: 10.1056/NEJMc0905265. No abstract available.
- Scheel PJ Jr, Feeley N, Sozio SM. Combined prednisone and mycophenolate mofetil treatment for retroperitoneal fibrosis: a case series. Ann Intern Med. 2011 Jan 4;154(1):31-6. doi: 10.7326/0003-4819-154-1-201101040-00005.
- Vaglio A, Palmisano A, Alberici F, Maggiore U, Ferretti S, Cobelli R, Ferrozzi F, Corradi D, Salvarani C, Buzio C. Prednisone versus tamoxifen in patients with idiopathic retroperitoneal fibrosis: an open-label randomised controlled trial. Lancet. 2011 Jul 23;378(9788):338-46. doi: 10.1016/S0140-6736(11)60934-3. Epub 2011 Jul 4.
- Binder M, Uhl M, Wiech T, Kollert F, Thiel J, Sass JO, Walker UA, Peter HH, Warnatz K. Cyclophosphamide is a highly effective and safe induction therapy in chronic periaortitis: a long-term follow-up of 35 patients with chronic periaortitis. Ann Rheum Dis. 2012 Feb;71(2):311-2. doi: 10.1136/annrheumdis-2011-200148. Epub 2011 Aug 22. No abstract available.
- Alberici F, Palmisano A, Urban ML, Maritati F, Oliva E, Manenti L, Ferretti S, Cobelli R, Buzio C, Vaglio A. Methotrexate plus prednisone in patients with relapsing idiopathic retroperitoneal fibrosis. Ann Rheum Dis. 2013 Sep 1;72(9):1584-6. doi: 10.1136/annrheumdis-2013-203267. Epub 2013 May 21. No abstract available.
- Fatima J, Gota C, Clair DG, Billings SD, Gornik HL. Inflammatory abdominal aortic aneurysm with retroperitoneal fibrosis. Circulation. 2014 Oct 7;130(15):1300-2. doi: 10.1161/CIRCULATIONAHA.114.010173. No abstract available.
- Fernando A, Pattison J, Horsfield C, D'Cruz D, Cook G, O'Brien T. [18F]-Fluorodeoxyglucose Positron Emission Tomography in the Diagnosis, Treatment Stratification, and Monitoring of Patients with Retroperitoneal Fibrosis: A Prospective Clinical Study. Eur Urol. 2017 Jun;71(6):926-933. doi: 10.1016/j.eururo.2016.10.046. Epub 2016 Nov 18.
Study record dates
Study Major Dates
Study Start (Actual)
Primary Completion (Anticipated)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Actual)
Study Record Updates
Last Update Posted (Actual)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Additional Relevant MeSH Terms
- Pathologic Processes
- Fibrosis
- Retroperitoneal Fibrosis
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Antirheumatic Agents
- Antineoplastic Agents
- Immunosuppressive Agents
- Immunologic Factors
- Hormones
- Hormones, Hormone Substitutes, and Hormone Antagonists
- Antineoplastic Agents, Alkylating
- Alkylating Agents
- Myeloablative Agonists
- Cyclophosphamide
- Glucocorticoids
Other Study ID Numbers
- Cyclophosphamide for IRPF
Plan for Individual participant data (IPD)
Plan to Share Individual Participant Data (IPD)?
Drug and device information, study documents
Studies a U.S. FDA-regulated drug product
Studies a U.S. FDA-regulated device product
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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