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

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2016 by Guangdong General Hospital
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital Identifier:
First received: October 29, 2011
Last updated: August 23, 2016
Last verified: August 2016
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.


Study Type: Observational
Study Design: 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

Resource links provided by NLM:

Further study details as provided by Guangdong General Hospital:

Primary Outcome Measures:
  • serum suPAR level when proteinuria reduction >=50% or complete remission [ Time Frame: 6 months after steriod alone or CsA plus steriod treatment ] [ Designated as safety issue: No ]
    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:
  • 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 ] [ Designated as safety issue: No ]
    serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission

Estimated Enrollment: 90
Study Start Date: January 2011
Estimated Study Completion Date: January 2017
Estimated Primary Completion Date: January 2017 (Final data collection date for primary outcome measure)
steroid-sensitive FSGS
steroid-dependent and resistant FSGS
Healthy volunteers


Ages Eligible for Study:   14 Years to 70 Years   (Child, Adult, Senior)
Genders Eligible for Study:   Both
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

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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

Please refer to this study by its identifier: NCT01468493

Contact: Wei Shi, MD,PhD 86-20-8385-0849

China, Guangdong
Nephrology Dept.,Guangdong General Hospital Recruiting
Guangzhou, Guangdong, China, 510080
Contact: Wei Shi, MD,PhD    86-20-8385-0849   
Sub-Investigator: Bin Zhang, MD,PhD         
Sub-Investigator: Ruizhao Li, MD         
Sponsors and Collaborators
Guangdong General Hospital
Principal Investigator: Wei Shi, MD,PhD Nephrology Dept.,Guangdong General Hospital
  More Information

Responsible Party: Wei Shi, Director of renal division of Guangdong General Hospital, Guangdong General Hospital Identifier: NCT01468493     History of Changes
Other Study ID Numbers: GGH-1-1 
Study First Received: October 29, 2011
Last Updated: August 23, 2016
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:

Additional relevant MeSH terms:
Glomerulosclerosis, Focal Segmental
Kidney Diseases
Urologic Diseases processed this record on October 25, 2016