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

Health Science Center of Xi'an Jiaotong University

Status: Unknown

Conditions: Focal Segmental Glomerulosclerosis

Treatments: Drug: prednisone; Drug: prednisone, FK506, MMF

Study type: Interventional

Funder types: Other

Identifiers

NCT00956059

JL-5MG-50MG-500MG

JG-YX-1

YW-JS-XX-TKMS

CSX-090630-SAHXJTU

DX-FSGS-1

DBDZL-1

Details and patient eligibility

About

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.

Full 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.

Enrollment: 40 estimated patients

Sex: All

Ages: 16 to 70 years old

Volunteers: No 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

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)

---

40 participants in 2 patient groups

prednisone, MMF and FK506

Experimental group

Treatment:

Drug: prednisone, FK506, MMF

prednisone

Active Comparator group

Treatment:

Drug: prednisone