NCT01468493

Brief 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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
90

participants targeted

Target at P50-P75 for all trials

Timeline
Completed

Started Jan 2011

Longer than P75 for all trials

Geographic Reach
1 country

1 active site

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2011

Completed
10 months until next milestone

First Submitted

Initial submission to the registry

October 29, 2011

Completed
11 days until next milestone

First Posted

Study publicly available on registry

November 9, 2011

Completed
7.2 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2019

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

January 1, 2019

Completed
Last Updated

April 24, 2017

Status Verified

April 1, 2017

Enrollment Period

8 years

First QC Date

October 29, 2011

Last Update Submit

April 20, 2017

Conditions

FSGS

Keywords

FSGSsuPAR

Outcome Measures

Primary Outcomes (1)

  • 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 Outcomes (1)

  • serum suPAR level after 6 months of steroid or CsA treatment without remission

    6 months after steroid alone or CsA plus steroid treatment

Study Arms (3)

steroid-sensitive FSGS

steroid-dependent and resistant FSGS

Healthy volunteers

Eligibility Criteria

Age14 Years - 70 Years
Sexall
Healthy VolunteersYes
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)
Sampling MethodNon-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

You may qualify if:

  • Age at entry is between 14 and 70 years
  • biopsy-proven primary FSGS
  • proteinuria \>=3 g/day
  • without corticosteroids or CsA treatment before entry

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

Nephrology Dept.,Guangdong General Hospital

Guangzhou, Guangdong, 510080, China

RECRUITING

Study Officials

  • Wei Shi, MD,PhD

    Nephrology Dept.,Guangdong General Hospital

    PRINCIPAL INVESTIGATOR

Central Study Contacts

Wei Shi, MD,PhD

CONTACT

86-20-8385-0849weishi_gz@126.com

Study Design

Study Type
observational
Observational Model
COHORT
Time Perspective
PROSPECTIVE
Sponsor Type
OTHER
Responsible Party
PRINCIPAL INVESTIGATOR
PI Title
Director of renal division of Guangdong General Hospital

Study Record Dates

First Submitted

October 29, 2011

First Posted

November 9, 2011

Study Start

January 1, 2011

Primary Completion

January 1, 2019

Study Completion

January 1, 2019

Last Updated

April 24, 2017

Record last verified: 2017-04

Locations

CN(1)