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

History of Changes

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:

Genetic and Rare Diseases Information Center resources: Focal Segmental Glomerulosclerosis Glomerulonephritis

U.S. FDA Resources

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 Kidney Diseases Nephritis Urologic Diseases

ClinicalTrials.gov processed this record on February 25, 2015

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