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

NCT00956059 · Status: UNKNOWN · Phase: NA · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2009-08-11

No results posted yet for this study

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.

Conditions

  • Focal Segmental Glomerulosclerosis

Interventions

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

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

Sponsors & Collaborators

  • Xi'an Jiaotong University

    lead OTHER

Principal Investigators

  • Baosong Gui, MD · The second affiliated hospital of Medical College, Xi'an Jiaotong University

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
16 Years
Max Age
70 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2009-09-30
Primary Completion
2012-12-31
Completion
2012-12-31

Countries

  • China

Study Locations

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Entities

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT00956059 on ClinicalTrials.gov