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

Sponsor

Health Science Center of Xi'an Jiaotong University (Other)

Overall Status

Unknown status

CT.gov ID

NCT00956059

Collaborator

(none)

Enrollment

Location

Arms

Duration (Months)

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Focal Segmental Glomerulosclerosis	Drug: prednisone, FK506, MMF Drug: prednisone	N/A

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.

Study Design

Study Type:

Interventional

Anticipated Enrollment :

40 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

None (Open Label)

Primary Purpose:

Treatment

Official Title:

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

Study Start Date :

Sep 1, 2009

Anticipated Primary Completion Date :

Dec 1, 2012

Anticipated Study Completion Date :

Dec 1, 2012

Arms and Interventions

Arm	Intervention/Treatment
Experimental: prednisone, MMF and FK506	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
Active Comparator: prednisone	Drug: 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

Arm

Intervention/Treatment

Experimental: prednisone, MMF and FK506

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

Active Comparator: prednisone

Drug: 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

Outcome Measures

Primary Outcome Measures

proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [16~24 weeks]

Eligibility Criteria

Criteria

Ages Eligible for Study:

16 Years to 70 Years

Sexes Eligible for Study:

All

Accepts Healthy Volunteers:

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