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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.
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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 August 17, 2017