Actively Recruiting
Study of Sirolimus in Idiopathic Retroperitoneal Fibrosis
Led by Peking University International Hospital · Updated on 2025-06-04
60
Participants Needed
1
Research Sites
439 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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 vena cava and cause serious complications such as aortic aneurysm, renal failure, and even death. The lesion is diffuse and difficult to resect. corticosteroid is the first-line medication, but the recurrence rate of the disease is high, especially after dose reduction of corticosteroid. Therefore, the combined use of immunosuppressants is very important in preventing disease recurrence and reducing the toxic and side effects of long-term corticosteroid. Sirolimus plays dual roles in inhibiting lymphocyte activation and fibroblast proliferation. It is inferred from its mechanism that sirolimus is a good potential treatment option for idiopathic retroperitoneal fibrosis. Therefore, we conducted this RCT on patients with idiopathic retroperitoneal fibrosis to determine the efficacy and safety of sirolimus.
CONDITIONS
Official Title
Study of Sirolimus in Idiopathic Retroperitoneal Fibrosis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- Diagnosis of idiopathic retroperitoneal fibrosis confirmed by CT, MRI, or biopsy if needed
- Elevated ESR and CRP levels due to the disease and/or active lesions visible on imaging
You will not qualify if you...
- Secondary retroperitoneal fibrosis
- Use of corticosteroids (over 10 mg prednisone per day), immunosuppressants, or biologics within 3 months before joining
- Allergy or serious adverse reactions to prednisone or sirolimus
- Severe proteinuria, anemia, low white blood cells or platelets, or interstitial pneumonia
- Uncontrolled diabetes, high blood pressure, high cholesterol, infections, heart failure, or other serious conditions
- Cancer
- Pregnancy or plans to become pregnant soon
- Inability to follow up or refusal to consent
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Trial Site Locations
Total: 1 location
1
Peking University International Hospital
Beijing, Beijing Municipality, China, 100000
Actively Recruiting
Research Team
H
Hui Gao, Doctor
CONTACT
Z
Zhan-guo Li, Professor
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
TREATMENT
Number of Arms
2
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