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

April 20, 2017 updated by: Wei Shi, Guangdong Provincial People's Hospital

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

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 Overview

Status

Unknown

Conditions

Study Type

Observational

Enrollment (Anticipated)

90

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510080
        • Recruiting
        • Nephrology Dept.,Guangdong General Hospital
        • Contact:
        • Sub-Investigator:
          • Bin Zhang, MD,PhD
        • Sub-Investigator:
          • Ruizhao Li, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

14 years to 70 years (Child, Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

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

Description

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

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Observational Models: Cohort
  • Time Perspectives: Prospective

Cohorts and Interventions

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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after steriod alone or CsA plus steriod treatment

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
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
6 months after steroid alone or CsA plus steroid treatment

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Guangdong Provincial People's Hospital

Investigators

  • Principal Investigator: Wei Shi, MD,PhD, Nephrology Dept.,Guangdong General Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2011

Primary Completion (Anticipated)

January 1, 2019

Study Completion (Anticipated)

January 1, 2019

Study Registration Dates

First Submitted

October 29, 2011

First Submitted That Met QC Criteria

November 8, 2011

First Posted (Estimate)

November 9, 2011

Study Record Updates

Last Update Posted (Actual)

April 24, 2017

Last Update Submitted That Met QC Criteria

April 20, 2017

Last Verified

April 1, 2017

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • GGH-1-1

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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