Nephritis, LupusPhase 2/3NCT01646736
Efficacy and Safety of Tripterygium Wilfordii in Patients With Lupus Nephritis
A Phase 2/3 study testing Tripterygium wilfordii Hook F, Cyclophosphamide and GC in people with Nephritis, Lupus, run by Peking Union Medical College Hospital at 1 site in China.
Trial summary
Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Nephritis, Lupus
- What is being tested?
- Tripterygium wilfordii Hook F, Cyclophosphamide and GC
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 130 participants
- Where
- 1 siteChina
- Study dates
- Jul 2012to Dec 2013
- Phase
- Phase 2/3
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Age 18-65 years with informed consent
- SLE defined by meeting 4 or more ACR classification criteria
- Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
- Active renal disease
Who cannot join
- Pregnant, lactating or further fertility requirements
- Serum creatinine > 3 mg/dL
- Serum ALT or AST > 3 times upper limit of normal
- Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
- Previous treated with cyclophosphamide or T2.
- Not discontinuing MMF, azathioprine, leflunomide, methotrexate, calcineurin inhibitor before 1 month of randomization.
- Active or chronic infection, including HIV, HCV, HBV, tuberculosis
- Patient with malignancy
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Deptment of Rheumatology, Peking Union Medical College Hospital
Beijing, Beijing Municipality, 100032
Fengchun Zhang, MD, 861069158792, ZhangFCcra@yahoo.com.cn
Fengchun Zhang, MD
About this study
Official title: Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.
Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.
- Conditions
- Nephritis, Lupus
- Being tested
- Tripterygium wilfordii Hook F, Cyclophosphamide, GC
- Keywords
- Lupus Nephritis, Cyclophosphamide, 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.
Tripterygium wilfordii Hook FDrug
Oral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks.
CyclophosphamideDrug
Cyclophosphamide 1.0 intravenous every month.
GCDrug
Prednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks.
| Study group | Role | What they receive |
|---|---|---|
| GC+CYC | Placebo comparator | Patients were treated with Glucocorticosteroid and Cyclophosphamide. Receives: Drug: Cyclophosphamide; Drug: GC |
| GC+T2 | Experimental | Patients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F). Receives: Drug: Tripterygium wilfordii Hook F; Drug: GC |
What is being measured
The primary outcome is the main question the study is designed to answer.
Renal Response
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
Measured: 24 weeks.
Secondary outcomes (4)
Renal Function
The change in glomerular filtration rate(GFR) from baseline to week 24.
Measured: 24 weeks
Serum Albumin Level
The change in serum albumin level from baseline to week 24.
Measured: 24 weeks
Complement
The change in complement components from baseline to week 24, including: CH50(total complement activity), C3 and C4 level measured by nephelometry.
Measured: 24 weeks
Anti-dsDNA
The change in anti-dsDNA antibody titers from baseline to week 24.
Measured: 24 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted20 Jul 2012 (estimated)
- Study startJul 2012
- Primary completionJul 2013 (estimated)
- Study completionDec 2013 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Nephritis, LupusStudies of the same condition, open and under way.
- More trials run by Peking Union Medical College HospitalThe sponsor's other registered studies.
- 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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 130 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Peking Union Medical College Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Fengchun Zhang, Peking Union Medical College Hospital
- Investigators
- Fengchun Zhang, MD, Principal investigator, Peking Union Medical College Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01646736
- Sponsor's protocol ID
- T2WILN
- Status last verified
- Jul 2012
- First submitted
- 18 Jul 2012
- Last updated
- 23 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 23 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of Efficacy and Safety of Glucocorticosteroid Combined With Oral T2 (Chloroform/Methanol Extract of Tripterygium Wilfordii Hook F) in the Treatment of Patients With Lupus Nephritis.
- ClinicalTrials.gov ID
- NCT01646736
- Acronym / sponsor ID
- T2WILN
- Conditions
- Nephritis, Lupus
- Keywords
- Lupus Nephritis, Cyclophosphamide, Tripterygium
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 130 participants (estimated)
- Lead sponsor
- Peking Union Medical College HospitalUniversity, hospital or other
- Study start
- Jul 2012
- Primary completion
- Jul 2013 (estimated)
- Study completion
- Dec 2013 (estimated)
- First posted
- 20 Jul 2012 (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.
Evaluation the clinical efficacy and safety profile of glucocorticosteroid combined with oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F) in the treatment of patients with lupus nephritis. Open-labeled, randomized, prospective multi-center clinical trial. Observation period of 24 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| GC+CYC | Placebo comparator | Drug: Cyclophosphamide, Drug: GCPatients were treated with Glucocorticosteroid and Cyclophosphamide. |
| GC+T2 | Experimental | Drug: Tripterygium wilfordii Hook F, Drug: GCPatients were treated with Glucocorticosteroid and oral T2 (chloroform/methanol extract of Tripterygium wilfordii Hook F). |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Age 18-65 years with informed consent
- SLE defined by meeting 4 or more ACR classification criteria
- Biopsy-proven active proliferative lupus glomerulonephritis ISN classification Class III or IV
- Active renal disease
Key exclusion criteria (8 listed)
- Pregnant, lactating or further fertility requirements
- Serum creatinine > 3 mg/dL
- Serum ALT or AST > 3 times upper limit of normal
- Severe, progressive renal, hepatic, hematological, gastrointestinal, pulmonary, cardiovascular, neurological, endocrine or cerebral disease
- Previous treated with cyclophosphamide or T2.
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 Hook FOral T2(Tripterygium wilfordii Hook F) 20mg thrice daily for 24 weeks. | Drug | GC+T2 |
| CyclophosphamideCyclophosphamide 1.0 intravenous every month. | Drug | GC+CYC |
| GCPrednisone or equivalent 1 mg/kg/d(up to 60 mg), gradually tapering to 7.5mg/d in 24 weeks. | Drug | GC+CYC, GC+T2 |
Primary outcome
Renal Response
Time frame: 24 weeks.
The proportion of patients achieving Complete Response (CR) and Partial Response(PR).
4 secondary outcomes
Renal Function
Time frame: 24 weeks
Serum Albumin Level
Time frame: 24 weeks
Complement
Time frame: 24 weeks
Anti-dsDNA
Time frame: 24 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Jul 2012.
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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.
Fengchun Zhang, MD principal investigator
Peking Union Medical College Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tripterygium wilfordii Hook F, Cyclophosphamide and GC in people with Nephritis, Lupus, run by Peking Union Medical College 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 8 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 23 Jul 2012. 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. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this combined phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Phase 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Hua Chen, MD (+861069158797, chenhua@pumch.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Renal Response (time frame: 24 weeks.). 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 23 Jul 2012.