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A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients (SuparSDRF)

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ClinicalTrials.gov Identifier: NCT01468493
Recruitment Status : Recruiting
First Posted : November 9, 2011
Last Update Posted : April 24, 2017
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital

Study Description
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Brief Summary:
The purpose of this study is to determine whether the improved responsiveness to treatment achieved by CsA in patients with steroid-resistant or steroid-dependent FSGS could be explained by CsA's inhibitory action on the circulating suPAR expression.

Condition or disease
FSGS

Study Design
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Study Type : Observational
Estimated Enrollment : 90 participants
Observational Model: Cohort
Time Perspective: Prospective
Official Title: A Prospective Controlled Follow-up of Serum Soluble Urokinase Receptor in the Cyclosporine A-treated Patients With Steroid-dependent and Steroid-resistant Focal Segmental Glomerulosclerosis
Study Start Date : January 2011
Estimated Primary Completion Date : January 2019
Estimated Study Completion Date : January 2019

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U.S. FDA Resources

Groups and Cohorts
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Group/Cohort
steroid-sensitive FSGS
steroid-dependent and resistant FSGS
Healthy volunteers


Outcome Measures
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Primary Outcome Measures :
  1. serum suPAR level when proteinuria reduction >=50% or complete remission [ Time Frame: 6 months after steriod alone or CsA plus steriod treatment ]
    serum suPAR level when proteinuria reduction of >=50% or complete remission occurs within <=6 months of steroid alone or CsA plus steroid treatment


Secondary Outcome Measures :
  1. serum suPAR level after 6 months of steroid or CsA treatment without remission [ Time Frame: 6 months after steroid alone or CsA plus steroid treatment ]
    serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission


Eligibility Criteria
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Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   Yes
Sampling Method:   Non-Probability Sample
Study Population
1)the patients with steroid-sensitive FSGS;2)the cyclosporine A-treated patients with steroid-dependent and steroid-resistant FSGS;3)the healthy volunteers
Criteria

Inclusion Criteria:

  • Age at entry is between 14 and 70 years
  • biopsy-proven primary FSGS
  • proteinuria >=3 g/day
  • without corticosteroids or CsA treatment before entry

Exclusion Criteria:

  • Chronic Inflammatory Diseases
  • malignant tumor
  • diabetes mellitus
  • contraindications for the treatment of corticosteroids or CsA treatment
  • untolerate to or unwilling to accept corticosteroids or CsA treatment
Contacts and Locations
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

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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): NCT01468493


Contacts
Contact: Wei Shi, MD,PhD 86-20-8385-0849 weishi_gz@126.com

Locations
China, Guangdong
Nephrology Dept.,Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wei Shi, MD,PhD    86-20-8385-0849    weishi_gz@126.com   
Sub-Investigator: Bin Zhang, MD,PhD         
Sub-Investigator: Ruizhao Li, MD         
Sponsors and Collaborators
Guangdong General Hospital
Investigators
Principal Investigator: Wei Shi, MD,PhD Nephrology Dept.,Guangdong General Hospital
More Information
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Study Description Study Design Groups and Cohorts Outcome Measures Eligibility Criteria Contacts and Locations More Information

Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital
ClinicalTrials.gov Identifier: NCT01468493     History of Changes
Other Study ID Numbers: GGH-1-1
First Posted: November 9, 2011    Key Record Dates
Last Update Posted: April 24, 2017
Last Verified: April 2017

Keywords provided by Wei Shi, Guangdong General Hospital:
FSGS
suPAR

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Glomerulonephritis
Nephritis
Kidney Diseases
Urologic Diseases