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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

Tracking Information
First Submitted Date  ICMJE August 10, 2009
First Posted Date  ICMJE August 11, 2009
Last Update Posted Date August 11, 2009
Study Start Date  ICMJE September 2009
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures  ICMJE
 (submitted: August 10, 2009)
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test [ Time Frame: 16~24 weeks ]
Original Primary Outcome Measures  ICMJE Same as current
Change History No Changes Posted
Current Secondary Outcome Measures  ICMJE Not Provided
Original Secondary Outcome Measures  ICMJE Not Provided
Current Other Pre-specified Outcome Measures Not Provided
Original Other Pre-specified Outcome Measures Not Provided
 
Descriptive Information
Brief Title  ICMJE Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Official Title  ICMJE Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
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.
Study Type  ICMJE Interventional
Study Phase  ICMJE Not Applicable
Study Design  ICMJE Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Condition  ICMJE Focal Segmental Glomerulosclerosis
Intervention  ICMJE
  • 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
Study Arms  ICMJE
  • Experimental: prednisone, MMF and FK506
    Intervention: Drug: prednisone, FK506, MMF
  • Active Comparator: prednisone
    Intervention: Drug: prednisone
Publications * 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.

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status  ICMJE Unknown status
Estimated Enrollment  ICMJE
 (submitted: August 10, 2009)
40
Original Estimated Enrollment  ICMJE Same as current
Estimated Study Completion Date  ICMJE December 2012
Estimated Primary Completion Date December 2012   (Final data collection date for primary outcome measure)
Eligibility Criteria  ICMJE

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
Sex/Gender  ICMJE
Sexes Eligible for Study: All
Ages  ICMJE 16 Years to 70 Years   (Child, Adult, Older Adult)
Accepts Healthy Volunteers  ICMJE No
Contacts  ICMJE Contact information is only displayed when the study is recruiting subjects
Listed Location Countries  ICMJE China
Removed Location Countries  
 
Administrative Information
NCT Number  ICMJE NCT00956059
Other Study ID Numbers  ICMJE CSX-090630-SAHXJTU
DBDZL-1
DX-FSGS-1
YW-JS-XX-TKMS
JL-5MG-50MG-500MG
JG-YX-1
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement  ICMJE Not Provided
Current Responsible Party Gui Baosong, The Second Affiliated Hospital of Medical College,Xi'an JiaoTong University
Original Responsible Party Same as current
Current Study Sponsor  ICMJE Health Science Center of Xi'an Jiaotong University
Original Study Sponsor  ICMJE Same as current
Collaborators  ICMJE Not Provided
Investigators  ICMJE
Study Chair: Baosong Gui, MD The second affiliated hospital of Medical College, Xi'an Jiaotong University
PRS Account Health Science Center of Xi'an Jiaotong University
Verification Date August 2009

ICMJE     Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP