FSGSSuparSDRFNCT01468493
A Prospective Controlled Study of Serum suPAR in the CsA-treated FSGS Patients
An observational study of FSGS, run by Guangdong Provincial People's Hospital at 1 site in China.
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. Read more about this study
- Who is it for?
- Ages 14 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- FSGS
- How many people
- 90 participants
- Where
- 1 siteChina
- Study dates
- Jan 2011to Jan 2019
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 14 to 70 years
- All sexes
- Healthy volunteers accepted
- Child, Adult, Older adult
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
Who may be able to join
- Age at entry is between 14 and 70 years
- biopsy-proven primary FSGS
- proteinuria >=3 g/day
- without corticosteroids or CsA treatment before entry
Who cannot join
- 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
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Nephrology Dept.,Guangdong General Hospital
Guangzhou, Guangdong, 510080
Wei Shi, MD,PhD, 86-20-8385-0849, weishi_gz@126.com
Bin Zhang, MD,PhD
About this study
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
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.
- Conditions
- FSGS
- Keywords
- FSGS, suPAR
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
| Study group | Role | What they receive |
|---|---|---|
| steroid-sensitive FSGS | Not described | |
| steroid-dependent and resistant FSGS | Not described | |
| Healthy volunteers | Not described |
What is being measured
The primary outcome is the main question the study is designed to answer.
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
Measured: 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
serum suPAR level after 6 months of steroid alone or CsA plus steroid treatment without remission
Measured: 6 months after steroid alone or CsA plus steroid treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Nov 2011 (estimated)
- Study startJan 2011
- Primary completionJan 2019 (estimated)
- Study completionJan 2019 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for FSGSStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 90 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Guangdong Provincial People's Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Shi, Guangdong Provincial People's Hospital
- Investigators
- Wei Shi, MD,PhD, Principal investigator, Nephrology Dept.,Guangdong General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01468493
- Sponsor's protocol ID
- GGH-1-1
- Acronym
- SuparSDRF
- Status last verified
- Apr 2017
- First submitted
- 29 Oct 2011
- Last updated
- 24 Apr 2017
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 24 Apr 2017. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT01468493
- Acronym / sponsor ID
- SuparSDRF / GGH-1-1
- Conditions
- FSGS
- Keywords
- FSGS, suPAR
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 90 participants (estimated)
- Lead sponsor
- Guangdong Provincial People's HospitalUniversity, hospital or other
- Study start
- Jan 2011
- Primary completion
- Jan 2019 (estimated)
- Study completion
- Jan 2019 (estimated)
- First posted
- 9 Nov 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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 design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| steroid-sensitive FSGS | – | – |
| steroid-dependent and resistant FSGS | – | – |
| Healthy volunteers | – | – |
Who may qualify
- Ages
- 14 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Child, Adult, Older adult
- 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
Key inclusion criteria (4 listed)
- Age at entry is between 14 and 70 years
- biopsy-proven primary FSGS
- proteinuria >=3 g/day
- without corticosteroids or CsA treatment before entry
Key exclusion criteria (5 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Primary outcome
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
1 secondary outcome
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
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Apr 2017.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Wei Shi, MD,PhD principal investigator
Nephrology Dept.,Guangdong General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of FSGS, run by Guangdong Provincial People's Hospital at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 5 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 24 Apr 2017. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wei Shi, MD,PhD (86-20-8385-0849, weishi_gz@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
serum suPAR level when proteinuria reduction >=50% or complete remission (time frame: 6 months after steriod alone or CsA plus steriod treatment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 24 Apr 2017.