Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Information source: Xi’an Jiaotong University College of Medicine
Information obtained from ClinicalTrials.gov on October 19, 2009
Link to the current ClinicalTrials.gov record.
Condition(s) targeted: Focal Segmental Glomerulosclerosis
Intervention: prednisone, FK506, MMF (Drug); prednisone (Drug)
Phase: N/A
Status: Not yet recruiting
Sponsored by: Xi’an Jiaotong University College of Medicine Official(s) and/or principal investigator(s):
Baosong Gui, MD, Study Chair, Affiliation: The second affiliated hospital of Medical College, Xi'an Jiaotong University
Overall contact:
Baosong Gui, MD, Phone: 86-29-87679917, Email: guibsdoctor@sina.com.cn
Summary
The aim of this clinical trial is to determine the effect and security of low-dose
Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis.
Clinical Details
Official title: Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Study design: Treatment, Randomized, Open Label, Active Control, Parallel Assignment, Safety/Efficacy Study
Primary outcome: proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Detailed description:
Focal segmental glomerular sclerosis (FSGS) is characterized by heavy proteinuria and
nephritic syndrome in clinic. The major pathological change is scarring of the glomerulus
that is focal and segmental. The incidence of FSGS is increasing in recent years, but no
unified protocol for FSGS treatment has been provided. Corticosteroid is the primary drug
for FSGS treatment in clinic. However, corticosteroid treatment has a low response rate as
20% in clinic but some severe side-effects. The side-effects of long-term corticosteroid
treatment urged researchers to find more reliable and secure methods for FSGS treatment. The
new immunosuppressants shed light on FSGS treatment recently. The usage of
immunosuppressants to FSGS treatment is in the preliminary stage and accounts for a few
problems. The main problems include the uncertainty of curative effects, the lack of
large-scale clinical trial, the side-effects of long-term application, and the high
recurrence rate after withdraw. FSGS is immune-induced damage, which includes abnormality of
many steps in humoral immunity and cellular immunity. According to it, we designed to
inhibit the immune response at multi-targets with Prednisone Combined With MMF and FK506.
Thus the dosage of these drugs can be decreased to a secure level for long-term treatment
while the side-effects can be controlled well. Prednisone Combined With MMF and FK506 then
can be used to FSGS treatment with effectiveness and security.
Eligibility
Minimum age: 16 Years.
Maximum age: 70 Years.
Gender(s): Both.
Criteria:
Inclusion Criteria:
- Urinary protein≥1. 0g/24h
- Biopsy-proved FSGS
- Age≥16years
- Understanding of the content of this study，signing informed consent form
- Adherence to drug taking and being able to be long-term followed up
Exclusion Criteria:
- Sharp deterioration of renal function
- Refractory hypertension
- Secondary FSGS
- Serious disease of liver，active stage of viral hepatitis，or AST、ALT≥2. 5 times of
baseline
- Serious myelosuppression
- Being unable to be long-term followed up
Locations and Contacts
Baosong Gui, MD, Phone: 86-29-87679917, Email: guibsdoctor@sina.com.cn
The second affiliated hospital of medical college, Xi'an Jiaotong University, Xi'an, Shaanxi 710004, China
Additional Information
Starting date: September 2009
Ending date: December 2012
Last updated: August 10, 2009
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