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

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ClinicalTrials.gov Identifier: NCT00956059
Recruitment Status : Unknown
Verified August 2009 by Health Science Center of Xi’an Jiaotong University.
Recruitment status was:  Not yet recruiting
First Posted : August 11, 2009
Last Update Posted : August 11, 2009
Sponsor:
Information provided by:
Health Science Center of Xi’an Jiaotong University

Study Description
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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 Not Applicable

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
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Study Type : Interventional  (Clinical Trial)
Estimated 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 : September 2009
Estimated Primary Completion Date : December 2012
Estimated Study Completion Date : December 2012

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Steroids

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

Eligibility Criteria
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Ages Eligible for Study:   16 Years to 70 Years   (Child, Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT00956059


Contacts
Contact: Baosong Gui, MD 86-29-87679917 guibsdoctor@sina.com.cn

Locations
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    guibsdoctor@sina.com.cn   
Sponsors and Collaborators
Health Science Center of Xi’an Jiaotong University
Investigators
Study Chair: Baosong Gui, MD The second affiliated hospital of Medical College, Xi'an Jiaotong University
More Information
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Responsible Party: Gui Baosong, The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University
ClinicalTrials.gov Identifier: NCT00956059     History of Changes
Other Study ID Numbers: CSX-090630-SAHXJTU
DBDZL-1
DX-FSGS-1
YW-JS-XX-TKMS
JL-5MG-50MG-500MG
JG-YX-1
First Posted: August 11, 2009    Key Record Dates
Last Update Posted: August 11, 2009
Last Verified: August 2009

Keywords provided by Health Science Center of Xi’an Jiaotong University:
focal segmental glomerulosclerosis
prednisone
mycophenolate mofetil
FK506

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases
Prednisone
Tacrolimus
Anti-Inflammatory Agents
Glucocorticoids
Hormones
 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