NCT05428826

Brief Summary

Adult patients with a diagnosis of idiopathic retroperitoneal fibrosis Prospective multicentric cohort study Intervention : administration of prednisone during 9 to 21 months at 1mg/kg/day at inclusion.

Trial Health

77
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
41

participants targeted

Target at P25-P50 for phase_4

Timeline
30mo left

Started Nov 2022

Longer than P75 for phase_4

Geographic Reach
1 country

15 active sites

Status
recruiting

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Progress59%
Nov 2022Nov 2028

First Submitted

Initial submission to the registry

June 7, 2022

Completed
16 days until next milestone

First Posted

Study publicly available on registry

June 23, 2022

Completed
5 months until next milestone

Study Start

First participant enrolled

November 25, 2022

Completed
4 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 25, 2026

Expected
2 years until next milestone

Study Completion

Last participant's last visit for all outcomes

November 25, 2028

Last Updated

May 25, 2025

Status Verified

May 1, 2025

Enrollment Period

4 years

First QC Date

June 7, 2022

Last Update Submit

May 21, 2025

Conditions

Idiopathic Retroperitoneal Fibrosis

Keywords

Steroid treatment

Outcome Measures

Primary Outcomes (1)

  • To compare the cumulative IRF relapse rate 12 months after discontinuation of steroids.

    The primary endpoint is the cumulate IRF relapse rate 12 months after discontinuation of steroids. The diagnosis of IRF relapse is based on the association of a clinical or biological criterion with a radiological criterion (i.e. composite criteria): * Clinical or biological criteria * recurrent or new-onset disease related symptoms * increase in C-reactive protein (CRP) \>20mg/L without other cause * And a Radiological criterion o increased of retroperitoneal fibrosis size as compared with the CT scan performed at remission. The primary endpoint will be centrally adjudicated.

    12 months after discontinuation of steroids

Secondary Outcomes (15)

  • To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion

    at inclusion

  • To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion

    at inclusion

  • To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at inclusion

    at inclusion

  • To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)

    9 months after the inclusion

  • To analyze the characteristics of hypermetabolism of IRF in FDG-PET/CT and their evolution at remission (M9)

    9 months after the inclusion

  • +10 more secondary outcomes

Study Arms (1)

Prednisone

EXPERIMENTAL

Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.

Drug: Prednisone

Interventions

PrednisoneDRUG

Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.

Prednisone

Eligibility Criteria

Age18 Years+
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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,
  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (15)

Médecine Interne

Agen, France, 47000, France

RECRUITING

Médecine interne

Brest, France, 29200, France

RECRUITING

Médecine interne et maladies infectieuses - GH Sud Haut Lévêque

Bordeaux, 33604, France

RECRUITING

Médecine interne - Ambroise Paré

Boulogne-Billancourt, 92100, France

RECRUITING

Médecine interne - Henri-Mondor

Créteil, 94000, France

RECRUITING

Médecine interne et immunologie clinique - Dijon

Dijon, 21000, France

RECRUITING

Médecine interne - Lille

Lille, 59000, France

ACTIVE NOT RECRUITING

Médecine Interne - La Timone

Marseille, 13005, France

RECRUITING

Médecine interne - Saint Antoine

Paris, 75012, France

RECRUITING

Médecine Interne, Vascularites et Myosites - La Pitié Salpêtrière

Paris, 75013, France

RECRUITING

Médecine interne - Cochin

Paris, 75014, France

RECRUITING

Médecine vasculaire - HEGP

Paris, 75015, France

RECRUITING

Médecine Interne - Bichat

Paris, 75018, France

RECRUITING

Néphrologie - Bichat

Paris, 75018, France

ACTIVE NOT RECRUITING

Médecine interne - Delafontaine

Saint-Denis, 93200, France

ACTIVE NOT RECRUITING

MeSH Terms

Conditions

Retroperitoneal Fibrosis

Interventions

Prednisone

Condition Hierarchy (Ancestors)

FibrosisPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

PregnadienediolsPregnadienesPregnanesSteroidsFused-Ring CompoundsPolycyclic Compounds

Study Officials

  • Aline DECHANET

    Assistance Publique - Hôpitaux de Paris (AP-HP)

    STUDY CHAIR

Central Study Contacts

Karim SACRE

CONTACT

01.40.25.60.19karim.sacre@aphp.fr

Khadija BENALI

CONTACT

01.40.25.64.15khadija.benali@aphp.fr

Study Design

Study Type
interventional
Phase
phase 4
Allocation
NA
Masking
NONE
Purpose
TREATMENT
Intervention Model
SINGLE GROUP
Model Details: Phase 4 Prednisone Dose : 1mg/kg/day at inclusion Route of administration : oral Duration of treatment: 9 to 21 months.
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

June 7, 2022

First Posted

June 23, 2022

Study Start

November 25, 2022

Primary Completion (Estimated)

November 25, 2026

Study Completion (Estimated)

November 25, 2028

Last Updated

May 25, 2025

Record last verified: 2025-05

Data Sharing

IPD Sharing
Will not share

Locations

FR(15)