Lupus NephritisNCT00935389
Prospective Study of TW in the Treatment of LN Type V With Gross Proteinuria
A study testing tripterygium glycosides in people with Lupus Nephritis and Proteinuria, run by Nanjing University School of Medicine at 2 sites in China.
Trial summary
The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis, Proteinuria, CTX
- What is being tested?
- tripterygium glycosides
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 44 participants
- Where
- 2 sitesChina
- Study dates
- Apr 2009to May 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
- SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
- Urine protein≥3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.
- All cases are type IV, confirmed by renal biopsy.
- All patients sign the informed consent and be willing to follow-up on time
Who cannot join
- Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
- Scr level above 1.5mg/dL, lasts more than 3 months.
- Heart, lung or central nervous systems involved or combined with severe infection.
- With liver function abnormal, ALT or AST being two times above the normal.
- Pregnant women or patients still in lactation.
Trial locations and contacts
2 sites in 1 country.
China2 sites
Research Institute of Nephrology, Jinling Hospital
Nanjing, Jiangsu, 210002
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria
The purpose of this study is to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.
Read the detailed description
Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
- Conditions
- Lupus Nephritis, Proteinuria, CTX
- Being tested
- tripterygium glycosides
- Medical subject headings
- Lupus Nephritis, Proteinuria
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
tripterygium glycosidesDrug
Also called TW
The onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d.
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressor | Experimental | TW 30mg,q.d.*3 months and reduced into 20mg b.i.d Receives: Drug: tripterygium glycosides |
What is being measured
The primary outcome is the main question the study is designed to answer.
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
Measured: 48 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted9 Jul 2009 (estimated)
- Study startApr 2009
- Primary completionApr 2011
- Study completionMay 2011
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Lupus NephritisStudies 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
- 44 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Hu Weixin, Doctor, Principal investigator, Jinling Hospital, China
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00935389
- Sponsor's protocol ID
- NJCT-0903
- Status last verified
- Jul 2009
- First submitted
- 8 Jul 2009
- Last updated
- 2 Aug 2011
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Aug 2011. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Control Study of TW in the Treatment of LN Type V With Gross Proteinuria
- ClinicalTrials.gov ID
- NCT00935389
- Acronym / sponsor ID
- NJCT-0903
- Conditions
- Lupus Nephritis, Proteinuria, CTX
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 44 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Apr 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 9 Jul 2009 (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 analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) and CTX in LN-V patients with gross proteinuria.
Detailed description
Compared with cyclophosphamide(CTX), to analyze the clinical effects and adverse reactions of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| immunosuppressor | Experimental | Drug: tripterygium glycosidesTW 30mg,q.d.*3 months and reduced into 20mg b.i.d |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- SLE patients aging 18-60 years, all of whom comply to the ISN/RPS classification.
- Urine protein≥3.0g/24h, Alb<30g/L and Scr<1.5mg/dL.
- All cases are type IV, confirmed by renal biopsy.
- All patients sign the informed consent and be willing to follow-up on time
Key exclusion criteria (5 listed)
- Accepted drug therapy, such as CTX MMF CsA FK506 or TW more than 2 weeks in the latest 3 months.
- Scr level above 1.5mg/dL, lasts more than 3 months.
- Heart, lung or central nervous systems involved or combined with severe infection.
- With liver function abnormal, ALT or AST being two times above the normal.
- Pregnant women or patients still in lactation.
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 glycosidesAlso: TWThe onset dosage should be 30mg/q.d. and can be reduced into 20mg b.i.d if CR obtained in 3 months. Without CR in 3 months, the dosage of 90mg/d will last for another 3 months and then reduced to 60mg/d. | Drug | immunosuppressor |
Primary outcome
To analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria.
Time frame: 48 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 2 Aug 2011.
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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.
Hu Weixin, Doctor principal investigator
Jinling Hospital, China
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing tripterygium glycosides in people with Lupus Nephritis and Proteinuria, run by Nanjing University School of Medicine at 2 sites 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: finished, as of the sponsor's last update on 2 Aug 2011. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites 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 analyze the clinical effects of tripterygium glycosides (TW) in LN-V patients with gross proteinuria. (time frame: 48 months). 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 2 Aug 2011.