Lupus NephritisNCT00881309
To Compare the Efficacy and Safety of Tripterygium (TW) Versus AZA in the Maintenance Therapy for Lupus Nephritis
A study testing Tripterygium in people with Lupus Nephritis, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
The purpose of this study is to: To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Lupus Nephritis
- What is being tested?
- Tripterygium
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 94 participants
- Where
- 1 siteChina
- Study dates
- Mar 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
- Patients who signed written informed consent form;
- SLE patient, aged between 18-60 years, female or male;
- Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy;
- All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;
- When recruited in the study, patients received partial remission or complete remission for 3 months;
- Complete remission: proteinuria < 0.4 g/24h, negative urine sediment, serum albumin > 35 g/L, elevated scr < 0.3 mg/dl, no extra-renal complications;
- Partial remission: proteinuria < 1.0 g/24h, urine RBC < 500000/ml without casts, serum albumin > 35 g/L, elevated scr <0.3 mg/dl, no extra-renal complications.
Who cannot join
- Patients who didn't sign written informed consent form or could not obey the protocol;
- Patients who didn't received the CR or PR criterion;
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit;
- WBC < 3000/mm3 in peripheral blood;
- Patients with abnormal of central nervous system.
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology,Jinling Hospital
Nanjing, Jiangsu, 210002
About this study
Official title: To Compare the Efficacy and Safety of Tripterygium (TW) vs Aza in the Maintenance Therapy for Lupus Nephritis
The purpose of this study is to:
- To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis
- To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis
Read the detailed description
Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic glomerulonephritis. It has been used to treat lupus nephritis for many years with less side effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus nephritis.
- Conditions
- Lupus Nephritis
- Being tested
- Tripterygium
- Medical subject headings
- Lupus Nephritis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
TripterygiumDrug
TW 90mg/d
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressor | Experimental | Not described Receives: Drug: Tripterygium |
What is being measured
The primary outcome is the main question the study is designed to answer.
complete remission rate
Measured: 2 years
Secondary outcomes (2)
renal relapse
Measured: 2 years
partial remission
Measured: 2 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted15 Apr 2009 (estimated)
- Study startMar 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
- 94 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Investigators
- Weixin Hu, Doctor, Principal investigator, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00881309
- Sponsor's protocol ID
- NJCT-0902
- Status last verified
- Apr 2009
- First submitted
- 14 Apr 2009
- Last updated
- 18 May 2011
- Results posted
- No
- Data monitoring committee
- Yes
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
- To Compare the Efficacy and Safety of Tripterygium (TW) vs Aza in the Maintenance Therapy for Lupus Nephritis
- ClinicalTrials.gov ID
- NCT00881309
- Acronym / sponsor ID
- NJCT-0902
- Conditions
- Lupus Nephritis
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 94 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Mar 2009
- Primary completion
- Apr 2011 (actual)
- Study completion
- May 2011 (actual)
- First posted
- 15 Apr 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:
- To access the efficacy of TW compared to Aza in the maintenance therapy for lupus nephritis
- To investigate the safety and tolerability of TW versus Aza in the maintenance therapy for lupus nephritis
Detailed description
Tripterygium (TW) is a Chinese traditional patent drugs in treating chronic glomerulonephritis. It has been used to treat lupus nephritis for many years with less side effects. We compare the efficacy and safety of TW vs Aza in the maintenance therapy of lupus nephritis.
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 |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (7 listed)
- Patients who signed written informed consent form;
- SLE patient, aged between 18-60 years, female or male;
- Patients diagnosed lupus nephritis according to ISN/RPS 2003 classification criteria, class Ⅲ, Ⅳ,Ⅳ+Ⅴ, Ⅲ+Ⅴ or Ⅴ LN by renal biopsy;
- All patients received induction therapy for 6-12 months, including MMF, CTX, FK506 or multi-target therapy;
- When recruited in the study, patients received partial remission or complete remission for 3 months;
Key exclusion criteria (5 listed)
- Patients who didn't sign written informed consent form or could not obey the protocol;
- Patients who didn't received the CR or PR criterion;
- Patients who have impaired liver function, with ALT/GPT or AST/GOT twice more than the normal upper limit;
- WBC < 3000/mm3 in peripheral blood;
- Patients with abnormal of central nervous system.
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 |
|---|---|---|
| TripterygiumTW 90mg/d | Drug | immunosuppressor |
Primary outcome
complete remission rate
Time frame: 2 years
2 secondary outcomes
renal relapse
Time frame: 2 years
partial remission
Time frame: 2 years
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.
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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.
Weixin Hu, Doctor principal investigator
Nanjing University School of Medicine
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 in people with Lupus Nephritis, 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 7 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 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?
complete remission rate (time frame: 2 years). 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 18 May 2011.