Study of Sirolimus in Idiopathic Retroperitoneal Fibrosis

PHASE2/PHASE3RecruitingINTERVENTIONAL
Enrollment

60

Participants

Timeline

Start Date

July 1, 2018

Primary Completion Date

December 31, 2025

Study Completion Date

December 31, 2026

Conditions
Retroperitoneal Fibrosis
Interventions
DRUG

Sirolimus

The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects.For experimental group, if a patient is assessed as treatment failure (TS), the patient should be withdrawn from the study and receive rescue treatment. Whereas, a patient would be transferred to the control group if he/ she cann't stand the side effects of sirolimus but not serious adverse event (SAE).

DRUG

Corticosteroid

The efficacy is evaluated at 12 weeks, and treatment will be adjusted according to the control of disease and adverse effects. For active comparator group, if a patient is assessed as treatment failure (TF), the patient should be withdrawn from the study and receive rescue treatment.

Trial Locations (1)

100000

RECRUITING

Peking University International Hospital, Beijing

All Listed Sponsors
lead

Peking University International Hospital

OTHER