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

FSGS Clinical Trial

— SuparSDRF  

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

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT01468493
• Other study ID #: GGH-1-1
• Status: Recruiting
• Phase: N/A
• First received: October 29, 2011
• Last updated: April 20, 2017
• Start date: January 2011
• Est. completion date: January 2019

Study information

• Verified date: April 2017
• Source: Guangdong General Hospital
• Contact: Wei Shi, MD,PhD
• Phone: 86-20-8385-0849
• Email: weishi_gz[@]126.com
• Is FDA regulated: No
• Study type: Observational

Clinical Trial 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.

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 90
• Est. completion date: January 2019
• Est. primary completion date: January 2019
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 14 Years to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• FSGS
• Glomerulosclerosis, Focal Segmental

Locations

Country	Name	City	State
China	Nephrology Dept.,Guangdong General Hospital	Guangzhou	Guangdong

Sponsors (1)

Lead Sponsor	Collaborator
Guangdong General Hospital

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	serum suPAR level when proteinuria reduction >=50% or complete remission	serum suPAR level when proteinuria reduction of >=50% or complete remission occurs within <=6 months of steroid alone or CsA plus steroid treatment	6 months after steriod alone or CsA plus steriod treatment
Secondary	serum suPAR level after 6 months of steroid or CsA treatment without remission	serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission	6 months after steroid alone or CsA plus steroid treatment