ProteinuriaNCT00801463
Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
A study testing tripterygium wilfordii (TW) in people with Proteinuria and Focal Segmental Glomerulosclerosis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS). Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Proteinuria, Focal Segmental Glomerulosclerosis
- What is being tested?
- tripterygium wilfordii (TW)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 67 participants
- Where
- 1 siteChina
- Study dates
- Jan 2009to Feb 2011
- Phase
- Interventional
- 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 18 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18-60 years at onset of signs or symptoms of FSGS
- Urine protein ≥ 3.5 g/24 h
- Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine<2.5mg/dl
- Biopsy confirmed as idiopathic FSGS (including all subtypes)
- Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
Who cannot join
- Secondary FSGS
- Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Malignancy
- Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance
- Peripheral white blood cells < 3000/ul
Show all 9Show fewer
- Clinical evidence of cirrhosis or chronic active liver diseases
- History of significant gastrointestinal disorder
- Allergy to study medications, and Inability to consent/assent
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
The purpose of this study is to assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).
Read the detailed description
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with FSGS. These studies show that the total effective rates were only around 50%. But this therapy had taken some side effects of prednisone. Except these studies, in recent studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of Chinese adult patients with idiopathic FSGS.
- Conditions
- Proteinuria, Focal Segmental Glomerulosclerosis
- Being tested
- tripterygium wilfordii (TW)
- Keywords
- Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii
- Medical subject headings
- Proteinuria, Glomerulosclerosis, Focal Segmental
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tripterygium wilfordii (TW)Drug
Also called tripterygium wilfordii
Pre 30mg/d +TW 120 mg/d, po for 12 weeks
| Study group | Role | What they receive |
|---|---|---|
| Large pred | Experimental | Prednisone 60mg/d*8 wks Receives: Drug: tripterygium wilfordii (TW) |
| small pred | Experimental | Pred 30mg/d*8wks Receives: Drug: tripterygium wilfordii (TW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
To assess the efficacy and safety of TW in the treatment of FSGS
Measured: 12 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted3 Dec 2008 (estimated)
- Study startJan 2009
- Primary completionJan 2011
- Study completionFeb 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for ProteinuriaStudies 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
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 67 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Zhi-hong Liu, M.D, Principal investigator, Research Institute of Nephrology, Jinling Hospital,
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00801463
- Sponsor's protocol ID
- NJCT-0801
- Status last verified
- Apr 2009
- First submitted
- 2 Dec 2008
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
PubMed 35224732
Study at a glance
From the registry record, last updated by the sponsor on 18 May 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prednisone Plus Tripterygium Wilfordii Treatment of Adult Patients With Idiopathic Focal Segmental Glomerulosclerosis
- ClinicalTrials.gov ID
- NCT00801463
- Acronym / sponsor ID
- NJCT-0801
- Conditions
- Proteinuria, Focal Segmental Glomerulosclerosis
- Keywords
- Focal Segmental Glomerulosclerosis, Prednisone, Tripterygium Wilfordii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 67 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Jan 2009
- Primary completion
- Jan 2011 (actual)
- Study completion
- Feb 2011 (actual)
- First posted
- 3 Dec 2008 (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 assess the efficacy of prednisone and tripterygium wilfordii in treated Focal Segmental Glomerulosclerosis (FSGS).
Detailed description
Primary FSGS is a leading cause of end stage renal disease in adults, with complete loss of kidney function in 50% of patients over 10 years. Steroids, which are currently used to treat the disease, are effective in part of patients. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with high-dose and over 6mo prednisone in patients with FSGS. These studies show that the total effective rates were only around 50%. But this therapy had taken some side effects of prednisone. Except these studies, in recent studies suggest that Tripterygium Wilfordii may be effective for passive Heymann nephritis, podocyte injury in nephrosis rats induced y puromycin aminonucleoside, and so on. FSGS is a podocytepathy. There was no-data of Prednisone and Tripterygium Wilfordii treatment of Chinese adult patients with idiopathic FSGS.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Large pred | Experimental | Drug: tripterygium wilfordii (TW)Prednisone 60mg/d*8 wks |
| small pred | Experimental | Drug: tripterygium wilfordii (TW)Pred 30mg/d*8wks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Age 18-60 years at onset of signs or symptoms of FSGS
- Urine protein ≥ 3.5 g/24 h
- Estimated glomerular filtration rate (GFR) ≥ 40 ml/min/1.73 m2, serum creatinine<2.5mg/dl
- Biopsy confirmed as idiopathic FSGS (including all subtypes)
- Willingness to follow the clinical trial protocol, including medications, and baseline and follow-up visits and procedures
Key exclusion criteria (9 listed)
- Secondary FSGS
- Prior therapy with sirolimus, Cyclosporine, MMF, azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Malignancy
- Previously diagnosed as diabetes mellitus type 1 or 2, or abnormal carbohydrate tolerance
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| tripterygium wilfordii (TW)Also: tripterygium wilfordiiPre 30mg/d +TW 120 mg/d, po for 12 weeks | Drug | Large pred, small pred |
Primary outcome
To assess the efficacy and safety of TW in the treatment of FSGS
Time frame: 12 months
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 May 2011.
- Derived from this study: PubMed 35224732Hodson EM, Sinha A, Cooper TE. Interventions for focal segmental glomerulosclerosis in adults. Cochrane Database Syst Rev. 2022 Feb 28;2(2):CD003233. doi: 10.1002/14651858.CD003233.pub3.
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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.
Zhi-hong Liu, M.D principal investigator
Research Institute of Nephrology, Jinling Hospital,
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tripterygium wilfordii (TW) in people with Proteinuria and Focal Segmental Glomerulosclerosis, run by Nanjing University School of Medicine 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 5 inclusion and 9 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: finished, as of the sponsor's last update on 18 May 2011. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
To assess the efficacy and safety of TW in the treatment of FSGS (time frame: 12 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT00801463, which also lists 1 linked publication.
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 18 May 2011.