Idiopathic Membranous NephropathyNCT01161459
Treatment of Idiopathic Membranous Nephropathy With Tripterygium Wilfordii Plus Steroid vs Tacrolimus Plus Steroid
A study testing Tripterygium wilfordii and FK506 in people with Idiopathic Membranous Nephropathy, run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy. To investigate the safety and tolerability of Tripterygium wilfordii plus steroid Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- Tripterygium wilfordii and FK506
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- Jun 2010to Oct 2013
- 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 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
- Age 18-65 years with informed consent
Who cannot join
- Patient with elevated serum creatinine concentration
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
- Patient is allergic or intolerant to macrolide antibiotics or tacrolimus
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu, 210002
About this study
Official title: Research Institute of Nephrology, Jinling Hospital
The purpose of this study is: To explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.
To investigate the safety and tolerability of Tripterygium wilfordii plus steroid
Read the detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- Tripterygium wilfordii, FK506
- Keywords
- Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tripterygium wilfordiiDrug
Also called TW
Tripterygium wilfordii 120mg/d Prednisone 30mg/d
FK506Drug
Also called Tacrolimus + Prednisone 30mg/d
capsule
| Study group | Role | What they receive |
|---|---|---|
| Tripterygium wilfordii | Experimental | 120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months Receives: Drug: Tripterygium wilfordii |
| FK506 | Active comparator | Not described Receives: Drug: FK506 |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Measured: 18 months
Secondary outcomes (1)
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid
Number of Participants with Adverse Events as a Measure of Safety and Tolerability
Measured: 18 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2010 (estimated)
- Study startJun 2010
- Primary completionApr 2012
- Study completionOct 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Idiopathic Membranous 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
- 100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Zhi-Hong Liu, M.D.
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Zhihong Liu, Master, Principal investigator, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01161459
- Sponsor's protocol ID
- NJCT-1004
- Status last verified
- May 2014
- First submitted
- 12 Jul 2010
- Last updated
- 2 Jun 2014
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 2 Jun 2014. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Institute of Nephrology, Jinling Hospital
- ClinicalTrials.gov ID
- NCT01161459
- Acronym / sponsor ID
- NJCT-1004
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- Idiopathic Membranous Nephropathy, Treatment, FK506, Tripterygium wilfordii
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (estimated)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Jun 2010
- Primary completion
- Apr 2012 (actual)
- Study completion
- Oct 2013 (actual)
- First posted
- 13 Jul 2010 (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 explore the potential role of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy.
To investigate the safety and tolerability of Tripterygium wilfordii plus steroid
Detailed description
Idiopathic membranous nephropathy is the most common cause of nephrotic syndrome in adults. Over the past decade, a number of studies have reported therapeutic efficacy for treatment with tacrolimus plus steroid in patients with nephrotic syndrome including patients with membranous nephropathy. This study will evaluate the safety and effectiveness of a traditional herbal extraction, Tripterygium wilfordii, plus steroid in reducing the amount of protein in the urine in patients with membranous nephropathy. A hundred patients with biopsy-proven membranous nephropathy will be recruited. They will be screened with a medical history, physical examination, blood tests, and an examination for infection, cancers, and other conditions that can cause membranous nephropathy. The investigators plan to conduct an open-label study of the efficacy and safety of Tripterygium wilfordii in the treatment of membranous nephropathy. Half of them will be treated with oral Tripterygium wilfordii plus steroids for 6 months, followed by 6 months of maintenance, and the other half treated with tacrolimus plus steroid as positive contrast. Proteinuria, renal function will be monitored. Complete remission is defined as 24-hour urinary protein excretion to less than 0.4 mg/day and serum albumin>35g/L. This study will explore the potential role of Tripterygium wilfordii in the treatment of membranous nephropathy, it's cost less .
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Tripterygium wilfordii | Experimental | Drug: Tripterygium wilfordii120mg/d for 6 months,then decrease to 60mg/d by 30mg/d every month for 12 months |
| FK506 | Active comparator | Drug: FK506 |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Biopsy-proven idiopathic membranous nephropathy
- Nephrotic syndrome with proteinuria ( > 3.5 g/day) and serum albumin < 30 g/dl
- Age 18-65 years with informed consent
Key exclusion criteria (6 listed)
- Patient with elevated serum creatinine concentration
- Prior therapy with sirolimus, CSA, MMF, or azathioprin, cytoxan, chlorambucil, levamisole, methotrexate, or nitrogen mustard in the last 90 days
- Active/serious infection
- Patient with hepatitis B surface antigen or who is hepatitis C antibody positive
- Patient who is diabetic
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 wilfordiiAlso: TWTripterygium wilfordii 120mg/d Prednisone 30mg/d | Drug | Tripterygium wilfordii |
| FK506Also: Tacrolimus + Prednisone 30mg/dcapsule | Drug | FK506 |
Primary outcome
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy
Time frame: 18 months
1 secondary outcome
Number of Participants with Adverse Events as a Measure of Safety and Tolerabilitysteroid
Time frame: 18 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 Jun 2014.
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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.
Zhihong Liu, Master principal investigator
Research Institute of Nephrology, Jinling Hospital, 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 wilfordii and FK506 in people with Idiopathic Membranous Nephropathy, run by Zhi-Hong Liu, M.D. 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 3 inclusion and 6 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 Jun 2014. 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?
The number of CR and PR of Tripterygium wilfordii plus steroid in the treatment of membranous nephropathy (time frame: 18 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 Jun 2014; AzTrials last refreshed its copy on 8 Nov 2026.