IgA NephropathyNCT00885547
Prospective Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis
A study testing tripterygium wilfordii (TW) in people with IgA Nephropathy, run by Nanjing University School of Medicine.
Trial summary
The purpose of this study is to: 1. To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis. 2. To evaluate the safety and tolerability of TW. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- tripterygium wilfordii (TW)
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 90 participants
- Where
- No sites listed yet
- 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
- 18-60 years old but no requirement for gender
- All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
- Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement
Who cannot join
- Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
- Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
- Severe infection
- Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
- Women during pregnancy and lactation
- Patients need to procreation lately
- Patients treated with TW or ARB within 4 months
About this study
Official title: Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
The purpose of this study is to:
- To evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
- To evaluate the safety and tolerability of TW.
Read the detailed description
Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).
- Conditions
- IgA Nephropathy
- Being tested
- tripterygium wilfordii (TW)
- Medical subject headings
- Glomerulonephritis, IGA
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
90 mg/d for 6 months
| Study group | Role | What they receive |
|---|---|---|
| immunosuppressor | Experimental | Not described Receives: Drug: tripterygium wilfordii (TW) |
What is being measured
The primary outcome is the main question the study is designed to answer.
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
Measured: 12 months
Secondary outcomes (1)
The percentage of total effect of the 3 groups and adverse event within the follow-up periods.
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 posted22 Apr 2009 (estimated)
- Study startMar 2009
- Primary completionApr 2011
- Study completionMay 2011
Why it stopped: low-rate of enrollment
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA NephropathyStudies 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
- 90 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Zheng Tang, Doctor, Principal investigator, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT00885547
- Sponsor's protocol ID
- NJCT-0904
- Status last verified
- Mar 2015
- First submitted
- 20 Apr 2009
- Last updated
- 2 Apr 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 2 Apr 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Prospective Clinical Study of TW in Treatment of IgAN With Asymptomatic Abnormal Urinalysis.
- ClinicalTrials.gov ID
- NCT00885547
- Acronym / sponsor ID
- NJCT-0904
- Conditions
- IgA Nephropathy
- Study type
- Interventional
- Recruitment status
- TerminatedReason stopped: low-rate of enrollment
- Enrolment
- 90 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
- 22 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 evaluate the latest effects of TW for IgA nephropathy (IgAN) with asymptomatic abnormal urinalysis.
- To evaluate the safety and tolerability of TW.
Detailed description
Patients who fit the inclusion criteria will be randomly divided into three groups: TW group (TW at dosage of 90 mg/d), ARB group (the control group, valsartan at dosage of 160 mg/d) and combined treatment group (TW at dosage of 60 mg/d and valsartan at dosage of 80 mg/d).
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 wilfordii (TW) |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- 18-60 years old but no requirement for gender
- All well fit the Diagnostic Criteria for Primary IgAN and IgAN with asymptomatic abnormal urinalysis
- Informed consent is obtained from each research subject who agrees to conduct a periodic follow-up according to the research arrangement
Key exclusion criteria (7 listed)
- Secondary IgA nephropathy, such as Henoch-Schönlein purpura nephritis, Lupus nephritis and so on
- Some secondary kidney diseases like diabetic nephropathy or other systemic diseases which may effect the pathologic and physiological function of kidney like hypertension and arteriosclerosis
- Severe infection
- Abnormality of liver function with glutamic pyruvic transaminase (GPT) or glutamic-oxal(o)acetic transaminase (GOT) more than twice upper limit of normal
- Women during pregnancy and 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 wilfordii (TW)Also: tripterygium wilfordii90 mg/d for 6 months | Drug | immunosuppressor |
Primary outcome
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment.
Time frame: 12 months
1 secondary outcome
The percentage of total effect of the 3 groups and adverse event within the follow-up periods.
Time frame: 12 months
Results and safety
The study was stopped early (reason given: low-rate of enrollment). Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 2 Apr 2015.
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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.
Zheng Tang, Doctor principal investigator
Nanjing University School of Medicine
Questions about this trial
What is this clinical trial studying?
A study testing tripterygium wilfordii (TW) in people with IgA Nephropathy, run by Nanjing University School of Medicine.
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 3 inclusion and 7 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: stopped early, as of the sponsor's last update on 2 Apr 2015. Status can change between updates, so confirm with the study contact before making plans.
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 was stopped early (reason given: low-rate of enrollment). Results are not available in the source record.
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?
The percentage got to complete remission (CR) of TW group, the combined treatment group, and the control group after the 3, 6 months treatment. (time frame: 12 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 Apr 2015.