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

NCT ID: NCT00956059

Last Updated: 2009-08-11

Basic Information

• Recruitment Status: UNKNOWN
• Clinical Phase: NA
• Total Enrollment: 40 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-09-30
• Study Completion Date: 2012-12-31

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.

Conditions

Focal Segmental Glomerulosclerosis

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

prednisone, MMF and FK506

Group Type: EXPERIMENTAL

prednisone, FK506, MMF

Intervention Type: DRUG

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

Group Type: ACTIVE_COMPARATOR

prednisone

Intervention Type: DRUG

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

Interventions

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

Intervention Type: 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

Intervention Type: DRUG

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

• Minimum Eligible Age: 16 Years
• Maximum Eligible Age: 70 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Xi'an Jiaotong University

OTHER

Sponsor Role: lead

Responsible Party

The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University

Principal Investigators

Baosong Gui, MD

Role: STUDY_CHAIR

The second affiliated hospital of Medical College, Xi'an Jiaotong University

Locations

The second affiliated hospital of medical college, Xi'an Jiaotong University

Xi'an, Shaanxi, China

Countries

China

Central Contacts

Baosong Gui, MD

Role: CONTACT

guibsdoctor@sina.com.cn

86-29-87679917

Facility Contacts

Baosong Gui, MD

Role: primary

guibsdoctor@sina.com.cn

86-29-87679917

References

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.

Reference Type: DERIVED

PMID: 35224732 (View on PubMed)

Other Identifiers

DBDZL-1

Identifier Type: -

Identifier Source: secondary_id

DX-FSGS-1

Identifier Type: -

Identifier Source: secondary_id

YW-JS-XX-TKMS

Identifier Type: -

Identifier Source: secondary_id

JL-5MG-50MG-500MG

Identifier Type: -

Identifier Source: secondary_id

JG-YX-1

Identifier Type: -

Identifier Source: secondary_id

CSX-090630-SAHXJTU

Identifier Type: -

Identifier Source: org_study_id