Status:
RECRUITING
Study of Sirolimus in Idiopathic Retroperitoneal Fibrosis
Lead Sponsor:
Peking University International Hospital
Conditions:
Retroperitoneal Fibrosis
Eligibility:
All Genders
18+ years
Phase:
PHASE2
PHASE3
Brief Summary
Retroperitoneal fibrosis refers to a group of diseases characterized by hyperplasia of the fibrosclerotic tissues in the retroperitoneal space, which can compress the surrounding ureters and inferior ...
Detailed Description
Retroperitoneal fibrosis refers to a group of diseases characterized by hyperplasia of the fibrosclerotic tissues in the retroperitoneal space, which mostly involve the abdominal aorta and iliac arter...
Eligibility Criteria
Inclusion
- Idiopathic retroperitoneal fibrosis diagnosed on CT or MRI. For patients with suspected secondary retroperitoneal fibrosis or atypical idiopathic retroperitoneal fibrosis suggested by imaging, idiopathic retroperitoneal fibrosis should be confirmed by puncture biopsy
- Increased ESR and CRP levels caused by this disease and/or active lesions suggested on imaging
Exclusion
- Secondary retroperitoneal fibrosis
- Having used corticosteroid (equivalent to \>10 mg per day of prednisone), immunosuppressant, or biologic within 3 months prior to enrollment
- Having any contraindication of prednisone or sirolimus, or allergy to sirolimus, or having experienced serious adverse reactions from the previous use of any of the above drugs
- Massive proteinuria (24-hour urine protein quantitation ≥3 g), moderate-to-severe anemia (hemoglobin \<90 g/L), agranulocytosis (white blood cell count \<1.5×10\^9/L or neutrophil count \<0.5×10\^9/L), platelet count \<50×10\^9/L, interstitial pneumonia
- Uncontrollable diabetes, hypertension, hyperlipidemia, infection, or heart failure, or other serious complications
- Malignancy
- Pregnancy or need for pregnancy in the near future
- Unable to adhere to follow-up or refuses to provide consent
Key Trial Info
Start Date :
July 1 2018
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 1 2026
Estimated Enrollment :
60 Patients enrolled
Trial Details
Trial ID
NCT04047576
Start Date
July 1 2018
End Date
December 1 2026
Last Update
June 4 2025
Active Locations (1)
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1
Peking University International Hospital
Beijing, Beijing Municipality, China, 100000