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A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients (SuparSDRF)
This study is currently recruiting participants.
Verified April 2017 by Wei Shi, Guangdong General Hospital
Sponsor:
Guangdong General Hospital
Information provided by (Responsible Party):
Wei Shi, Guangdong General Hospital
ClinicalTrials.gov Identifier:
NCT01468493
First received: October 29, 2011
Last updated: April 20, 2017
Last verified: April 2017
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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 Wei Shi, 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 ]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 ]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 2019 |
| Estimated Primary Completion Date: | January 2019 (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 (Child, Adult, Senior) |
| Sexes Eligible for Study: | All |
| 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
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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
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
| 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: | April 20, 2017 |
Keywords provided by Wei Shi, Guangdong General Hospital:
|
FSGS suPAR |
Additional relevant MeSH terms:
|
Glomerulosclerosis, Focal Segmental Glomerulonephritis Nephritis Kidney Diseases Urologic Diseases |
ClinicalTrials.gov processed this record on June 27, 2017