Stopping steroid treatment early in patients with idiopathic retroperitoneal fibrosis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This study investigates the effects of early discontinuation of steroid treatment in adult patients diagnosed with idiopathic retroperitoneal fibrosis. Eligible participants will receive prednisone for a period of 9 to 21 months, with monitoring through clinical examinations and imaging tests. Patients will be screened based on their FDG-PET/CT results, and those with negative results will be excluded from the study. Follow-up visits will assess treatment compliance, adverse events, and disease progression.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Patient over 18 years old
* New onset or untreated relapsing of active idiopathic retroperitoneal fibrosis (IRF) defined by the association of:
* Related-disease symptoms (Appendix 17.2) or elevated CRP level (\>20 mg/l) AND
* Retroperitoneal peri-aortic mass that surrounds the abdominal vessels on CT-scan

Exclusion Criteria:

* Secondary retroperitoneal fibrosis including drug-related retroperitoneal fibrosis, active infections (such as tuberculosis) or malignancies, systemic vasculitis (such as Anti-neutrophil cytoplasmic autoantibody (ANCA)-associated vasculitis), Erdheim-Chester disease (Appendix 17.3),patients with IgG4 disease may be enrolled
* Contraindication to perform FDG-PET/CT,
* Contraindication to perform CT scan with injection of contrast agent,
* Contraindication to treatment by prednisone
* Active infection
* Acute or chronic liver disease that is deemed sufficiently severe to impair their ability to participate in the trial,
* Active or history of malignancy in last 5 years. Individuals with squamous cell or basal cell skin carcinomas and individuals with cervical carcinoma in situ may be enrolled if they have received curative surgical treatment,
* Serum creatinine level greater than 400 µmol/L that cannot be attributed to underlying IRF,
* Live vaccination received from 4 weeks before inclusion,
* Inhaled glucocorticoids (except for patients with documented asthma),
* Any previous treatment with rituximab, methotrexate, alemtuzumab, cyclophosphamide, azathioprine, mycophenolate mofetil, infliximab, adalimumab, etanercept within the past 3 months,
* Pregnancy or breastfeeding,
* Non-affiliation to a social security regime,
* Subject deprived of freedom, subject under a legal protective measure
* Refusal to participate

Where it's running

• Médecine Interne
  Agen, France, France Recruiting
• Médecine interne
  Brest, France, France Recruiting
• Médecine interne et maladies infectieuses - GH Sud Haut Lévêque
  Bordeaux, France Recruiting
• Médecine interne - Ambroise Paré
  Boulogne-Billancourt, France Recruiting
• Médecine interne - Henri-Mondor
  Créteil, France Recruiting
• Médecine interne et immunologie clinique - Dijon
  Dijon, France Recruiting

Study contacts

• Study coordinator: Karim SACRE
• Email: karim.sacre@aphp.fr
• Phone: 01.40.25.60.19

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

• National registry for idiopathic retroperitoneal fibrosis in China

  This study is trying to gather information from patients with idiopathic retroperitoneal fibrosis in China to better understand the condition and its effects on people's health.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT04314323

• Cohort study of idiopathic retroperitoneal fibrosis in China

  This study looks at how idiopathic retroperitoneal fibrosis affects patients in China and how they respond to different treatments.

  Recruiting Peking Union Medical College Hospital · Beijing, Beijing Municipality · NCT04312854

• National Registry for Rare Kidney Diseases

  This study is collecting health information from people with rare kidney diseases to help improve treatments and create better care guidelines.

  Recruiting UK Kidney Association · Bristol, South West · NCT06065852

How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.