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

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified August 2009 by Health Science Center of Xi’an Jiaotong University.
Recruitment status was:  Not yet recruiting
Information provided by:
Health Science Center of Xi’an Jiaotong University Identifier:
First received: August 10, 2009
Last updated: NA
Last verified: August 2009
History: No changes posted
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 Intervention
Focal Segmental Glomerulosclerosis
Drug: prednisone, FK506, MMF
Drug: prednisone

Study Type: Interventional
Study Design: Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis

Resource links provided by NLM:

Further study details as provided by Health Science Center of Xi’an Jiaotong University:

Primary Outcome Measures:
  • proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [ Time Frame: 16~24 weeks ]

Estimated Enrollment: 40
Study Start Date: September 2009
Estimated Study Completion Date: December 2012
Estimated Primary Completion Date: December 2012 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: prednisone, MMF and FK506 Drug: prednisone, FK506, MMF 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

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.

Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No

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
  Contacts and Locations
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Please refer to this study by its identifier: NCT00956059

Contact: Baosong Gui, MD 86-29-87679917

China, Shaanxi
The second affiliated hospital of medical college, Xi'an Jiaotong University Not yet recruiting
Xi'an, Shaanxi, China, 710004
Contact: Baosong Gui, MD    86-29-87679917   
Sponsors and Collaborators
Health Science Center of Xi’an Jiaotong University
Study Chair: Baosong Gui, MD The second affiliated hospital of Medical College, Xi'an Jiaotong University
  More Information

Responsible Party: Gui Baosong, The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University Identifier: NCT00956059     History of Changes
Other Study ID Numbers: CSX-090630-SAHXJTU
Study First Received: August 10, 2009
Last Updated: August 10, 2009

Keywords provided by Health Science Center of Xi’an Jiaotong University:
focal segmental glomerulosclerosis
mycophenolate mofetil

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases
Anti-Inflammatory Agents
Hormones, Hormone Substitutes, and Hormone Antagonists
Physiological Effects of Drugs
Antineoplastic Agents, Hormonal
Antineoplastic Agents
Immunosuppressive Agents
Immunologic Factors
Calcineurin Inhibitors
Enzyme Inhibitors
Molecular Mechanisms of Pharmacological Action processed this record on May 25, 2017