Clinical trial NCT00956059: Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Official title: Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Study type: INTERVENTIONAL
Overall status: UNKNOWN
Phase: NA
Conditions: Focal Segmental Glomerulosclerosis
Keywords: focal segmental glomerulosclerosis
prednisone
mycophenolate mofetil
FK506
Lead sponsor: Xi'an Jiaotong University
Sponsor class: OTHER
First posted: 2009-08-11
Enrollment: 40
Sex: ALL
Minimum age (years): 16
Maximum age (years): 70
Standard ages: CHILD
ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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 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

Primary outcomes:
measure: proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
timeFrame: 16~24 weeks
Secondary outcomes:
Other outcomes:
Locations:
city: Xi'an
country: China
facility: The second affiliated hospital of medical college, Xi'an Jiaotong University
state: Shaanxi
Study officials:
affiliation: The second affiliated hospital of Medical College, Xi'an Jiaotong University
name: Baosong Gui, MD
role: STUDY_CHAIR
References:
citation: Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.