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

Primary Purpose

Focal Segmental Glomerulosclerosis

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
prednisone, FK506, MMF
prednisone
Sponsored by
Health Science Center of Xi'an Jiaotong University
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Focal Segmental Glomerulosclerosis focused on measuring focal segmental glomerulosclerosis, prednisone, mycophenolate mofetil, FK506

Eligibility Criteria

16 Years - 70 Years (Child, Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

  • The second affiliated hospital of medical college, Xi'an Jiaotong University

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Active Comparator

Arm Label

prednisone, MMF and FK506

prednisone

Arm Description

Outcomes

Primary Outcome Measures

proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test

Secondary Outcome Measures

Full Information

First Posted
August 10, 2009
Last Updated
August 10, 2009
Sponsor
Health Science Center of Xi'an Jiaotong University
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1. Study Identification

Unique Protocol Identification Number
NCT00956059
Brief Title
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Official Title
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
Study Type
Interventional

2. Study Status

Record Verification Date
August 2009
Overall Recruitment Status
Unknown status
Study Start Date
September 2009 (undefined)
Primary Completion Date
December 2012 (Anticipated)
Study Completion Date
December 2012 (Anticipated)

3. Sponsor/Collaborators

Name of the Sponsor
Health Science Center of Xi'an Jiaotong University

4. Oversight

Data Monitoring Committee
No

5. Study Description

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Focal Segmental Glomerulosclerosis
Keywords
focal segmental glomerulosclerosis, prednisone, mycophenolate mofetil, FK506

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
None (Open Label)
Allocation
Randomized
Enrollment
40 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
prednisone, MMF and FK506
Arm Type
Experimental
Arm Title
prednisone
Arm Type
Active Comparator
Intervention Type
Drug
Intervention Name(s)
prednisone, FK506, MMF
Intervention Description
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
Intervention Type
Drug
Intervention Name(s)
prednisone
Intervention Description
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
Primary Outcome Measure Information:
Title
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Time Frame
16~24 weeks

10. Eligibility

Sex
All
Minimum Age & Unit of Time
16 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility 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
Central Contact Person:
First Name & Middle Initial & Last Name or Official Title & Degree
Baosong Gui, MD
Phone
86-29-87679917
Email
guibsdoctor@sina.com.cn
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baosong Gui, MD
Organizational Affiliation
The second affiliated hospital of Medical College, Xi'an Jiaotong University
Official's Role
Study Chair
Facility Information:
Facility Name
The second affiliated hospital of medical college, Xi'an Jiaotong University
City
Xi'an
State/Province
Shaanxi
ZIP/Postal Code
710004
Country
China
Facility Contact:
First Name & Middle Initial & Last Name & Degree
Baosong Gui, MD
Phone
86-29-87679917
Email
guibsdoctor@sina.com.cn

12. IPD Sharing Statement

Citations:
PubMed Identifier
35224732
Citation
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.
Results Reference
derived

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

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