- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT00956059
Therapeutic Effect of Low-dose Prednisone Combined With MMF and FK506 in Focal Segmental Glomerulosclerosis
August 10, 2009 updated by: Health Science Center of Xi'an Jiaotong University
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.
Study Overview
Status
Unknown
Conditions
Intervention / Treatment
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
Interventional
Enrollment (Anticipated)
40
Phase
- Not Applicable
Contacts and Locations
This section provides the contact details for those conducting the study, and information on where this study is being conducted.
Study Contact
- Name: Baosong Gui, MD
- Phone Number: 86-29-87679917
- Email: guibsdoctor@sina.com.cn
Study Locations
-
-
Shaanxi
-
Xi'an, Shaanxi, China, 710004
- The second affiliated hospital of medical college, Xi'an Jiaotong University
-
Contact:
- Baosong Gui, MD
- Phone Number: 86-29-87679917
- Email: guibsdoctor@sina.com.cn
-
-
Participation Criteria
Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.
Eligibility Criteria
Ages Eligible for Study
16 years to 70 years (Child, Adult, Older Adult)
Accepts Healthy Volunteers
No
Genders Eligible for Study
All
Description
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
Study Plan
This section provides details of the study plan, including how the study is designed and what the study is measuring.
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: None (Open Label)
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
---|---|
Experimental: prednisone, MMF and FK506
|
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
|
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
|
What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Time Frame |
---|---|
proteinuria,serum protein,Scr,blood routine examination,liver function test,blood glucose and lipid test
Time Frame: 16~24 weeks
|
16~24 weeks
|
Collaborators and Investigators
This is where you will find people and organizations involved with this study.
Investigators
- Study Chair: Baosong Gui, MD, The second affiliated hospital of medical college, Xi'an Jiaotong University
Publications and helpful links
The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.
Study record dates
These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.
Study Major Dates
Study Start
September 1, 2009
Primary Completion (Anticipated)
December 1, 2012
Study Completion (Anticipated)
December 1, 2012
Study Registration Dates
First Submitted
August 10, 2009
First Submitted That Met QC Criteria
August 10, 2009
First Posted (Estimate)
August 11, 2009
Study Record Updates
Last Update Posted (Estimate)
August 11, 2009
Last Update Submitted That Met QC Criteria
August 10, 2009
Last Verified
August 1, 2009
More Information
Terms related to this study
Additional Relevant MeSH Terms
Other Study ID Numbers
- CSX-090630-SAHXJTU
- DBDZL-1
- DX-FSGS-1
- YW-JS-XX-TKMS
- JL-5MG-50MG-500MG
- JG-YX-1
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
Clinical Trials on Focal Segmental Glomerulosclerosis
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Genzyme, a Sanofi CompanyCompletedPrimary Focal Segmental GlomerulosclerosisUnited States, Brazil, Germany, Italy, Spain
-
Nanjing University School of MedicineWithdrawnFocal GlomerulosclerosisChina
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Complexa, Inc.Medpace, Inc.; MicroConstants; Kidney Research Network, formerly NephCure Accelerating... and other collaboratorsCompletedPrimary Focal Segmental GlomerulosclerosisUnited States
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National Institute of Diabetes and Digestive and...Genentech, Inc.; Indiana UniversityCompletedFocal Segmental Glomerulosclerosis (FSGS)United States
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National Institute of Diabetes and Digestive and...The Cleveland ClinicCompleted
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Mayo ClinicUniversity Health Network, Toronto; National Institute of Diabetes and Digestive... and other collaboratorsCompletedPrimary Focal Segmental GlomerulosclerosisCanada, United States
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National Institute of Diabetes and Digestive and...Completed
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NYU Langone HealthNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK); University... and other collaboratorsCompletedFocal Segmental GlomerulosclerosisUnited States, Canada
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