Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

Focal Segmental Glomerulosclerosis Clinical Trial

Official title:

Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

Clinical Trial Details — Status: Not yet recruiting

Administrative data

• NCT number: NCT00956059
• Other study ID #: CSX-090630-SAHXJTU
• Secondary ID: DBDZL-1DX-FSGS-1
• Status: Not yet recruiting
• Phase: N/A
• First received: August 10, 2009
• Last updated: August 10, 2009
• Start date: September 2009
• Est. completion date: December 2012

Study information

• Verified date: August 2009
• Source: Xi’an Jiaotong University College of Medicine
• Contact: Baosong Gui, MD
• Phone: 86-29-87679917
• Email: guibsdoctor[@]sina.com.cn
• Is FDA regulated: No
• Health authority: China: Ethics Committee
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Not yet recruiting
• Enrollment: 40
• Est. completion date: December 2012
• Est. primary completion date: December 2012
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 16 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Focal Segmental Glomerulosclerosis
• Glomerulosclerosis, Focal Segmental

Intervention

Drug:
• prednisone, FK506, MMF
1.in the initial 3 months,prednisone dosage is 30mg per day;in the following 4~6 months,prednisone dose decreased to 20mg per day,then tapered gradually to 10mg per day;2.the initial dosage of FK506 is 0.2mg/kg/d, twice per day,the maintenance dosage is adjust to the serum concentration of FK506 (is maintained at the level of 6~10µg/L);3. the initial dosage of MMF is 1.0g, twice per day,then reduce to 0.75 g, twice per day after 3 months
• prednisone
In the initial 16~24 weeks,prednisone is given at full dose of 1mg/kg/d,then prednisone is tapered gradually,the whole course of treatment is 52 weeks

Locations

Country	Name	City	State
China	The second affiliated hospital of medical college, Xi'an Jiaotong University	Xi'an	Shaanxi

Sponsors (1)

Lead Sponsor	Collaborator
Xi’an Jiaotong University College of Medicine

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test		16~24 weeks	Yes