A Prospective Controlled Follow-up of Serum suPAR in the CsA-treated Patients With Steroid-dependent and Steroid-resistant Focal Segmental Glomerulosclerosis (FSGS) (SuparSDRF)

This study is currently recruiting participants. (see Contacts and Locations)
Verified August 2013 by Guangdong General Hospital
Sponsor:
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01468493
First received: October 29, 2011
Last updated: August 27, 2013
Last verified: August 2013
  Purpose

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
FSGS

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 2014
Estimated Primary Completion Date: January 2014 (Final data collection date for primary outcome measure)
Groups/Cohorts
steroid-sensitive FSGS
steroid-dependent and resistant FSGS
Healthy volunteers

  Eligibility

Ages Eligible for Study:   14 Years to 70 Years
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

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
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 ClinicalTrials.gov identifier: 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

No publications provided

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
Study First Received: October 29, 2011
Last Updated: August 27, 2013
Health Authority: China: Ethics Committee

Keywords provided by Guangdong General Hospital:
FSGS
suPAR

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

ClinicalTrials.gov processed this record on August 26, 2014