Idiopathic Membranous NephropathyNCT01799460
Study on Single-nucleotide-polymorphism in Idiopathic Membranous Nephropathy
An observational study of Idiopathic Membranous Nephropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach… Read more about this study
- Who is it for?
- Ages 18 to 70 yearsHealthy volunteers can take part
- Conditions the study is for
- Idiopathic Membranous Nephropathy
- What is being tested?
- The Comprehensive Treatment Regimen of Traditional Chinese Medicine and The immunosuppressive agents
- Type of treatment
- Pill or oral medicine
- How many people
- 80 participants
- Where
- 1 siteChina
- Study dates
- Dec 2010to Aug 2013
- Phase
- Observational
- 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 70 years
- All sexes
- Healthy volunteers accepted
- Adult, Older adult
Study population: idiopathic membranous nephropathy
Who may be able to join
- Clinical diagnosis of idiopathic membranous nephropathy
- Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g
- Voluntarily participated in the study and signed an informed consent
Who cannot join
- Combined life-threatening complications such as serious infection
- Abnormal glucose metabolism
- Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc
- Pregnancy or breast-feeding women
- Undergoing other clinical trials
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Shanghai University of Traditional Chinese Medicine
Shanghai, Shanghai Municipality, 200032
Wang Lin, PHD, 86-13816583673, happytlynn@163.com
About this study
Official title: Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies
The purpose of this study is to analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.
Read the detailed description
The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.
- Conditions
- Idiopathic Membranous Nephropathy
- Being tested
- The Comprehensive Treatment Regimen of Traditional Chinese Medicine, The immunosuppressive agents
- Keywords
- single-nucleotide-polymorphism, Traditional Chinese Medicine, the Comprehensive Treatment Regimen
- Medical subject headings
- Glomerulonephritis, Membranous
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
The Comprehensive Treatment Regimen of Traditional Chinese MedicineDrug
Also called ShenQiMoShen Decoction, HuoXueTongMai Capsule, HeiLiaoDou Particle
①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day
②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily.
③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily.
The immunosuppressive agentsDrug
Also called Glucocorticoid, Cyclosporine, Cyclophosphamide, Tacrolimus
According to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis
| Study group | Role | What they receive |
|---|---|---|
| CR/CTR group | The complete remission group treated by the Comprehensive Treatment Regimen Receives: Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine | |
| NR/CTR group | The non-remission group treated by the Comprehensive Treatment Regimen Receives: Drug: The Comprehensive Treatment Regimen of Traditional Chinese Medicine | |
| CR/IA group | The complete remission group treated by Immunosuppressive Agents Receives: Drug: The immunosuppressive agents | |
| NR/IA group | The non-remission group treated by Immunosuppressive Agents. Receives: Drug: The immunosuppressive agents |
What is being measured
The primary outcome is the main question the study is designed to answer.
Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach
Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.
Measured: one year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted26 Feb 2013 (estimated)
- Study startDec 2010
- Primary completionAug 2013 (estimated)
- Study completionAug 2013 (estimated)
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
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 80 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Wang Lin, PHD,MD, Study director, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01799460
- Sponsor's protocol ID
- ShanghaiMEC-2011
- Other IDs
- 11YZ65
- Status last verified
- Apr 2013
- First submitted
- 8 Jan 2013
- Last updated
- 23 Apr 2013
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 23 Apr 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Mechanism Research of Traditional Chinese Medicine (the Comprehensive Treatment Regimen) in Treating Idiopathic Membranous Nephropathy by Genomewide Association Studies
- ClinicalTrials.gov ID
- NCT01799460
- Acronym / sponsor ID
- ShanghaiMEC-2011
- Conditions
- Idiopathic Membranous Nephropathy
- Keywords
- single-nucleotide-polymorphism, Traditional Chinese Medicine, the Comprehensive Treatment Regimen
- Study type
- Observational
- Recruitment status
- Unknown status
- Enrolment
- 80 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Study start
- Dec 2010
- Primary completion
- Aug 2013 (estimated)
- Study completion
- Aug 2013 (estimated)
- First posted
- 26 Feb 2013 (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 analysis the different genotype in the idiopathic membranous nephropathy patients which with different therapeutic outcomes after treated by the Comprehensive Treatment Regimen or immunosuppressive agents, and so as to looking for ideal markers to assess appropriate treatment approach and the long-term efficacy.
Detailed description
The primary objective of this study is to looking for the gene level predictors in the patients who suffered from idiopathic membranous nephropathy. And according to the predictors, the clinicians could make a decision which method should be taken on IMN patients, Traditional Chinese Medicine or western medicine, and could get better results.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
- Number of arms
- 4
| Arm | Type | Receives |
|---|---|---|
| CR/CTR group | – | Drug: The Comprehensive Treatment Regimen of Traditional Chinese MedicineThe complete remission group treated by the Comprehensive Treatment Regimen |
| NR/CTR group | – | Drug: The Comprehensive Treatment Regimen of Traditional Chinese MedicineThe non-remission group treated by the Comprehensive Treatment Regimen |
| CR/IA group | – | Drug: The immunosuppressive agentsThe complete remission group treated by Immunosuppressive Agents |
| NR/IA group | – | Drug: The immunosuppressive agentsThe non-remission group treated by Immunosuppressive Agents. |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Accepted
- Age groups
- Adult, Older adult
- Study population
- idiopathic membranous nephropathy
Key inclusion criteria (3 listed)
- Clinical diagnosis of idiopathic membranous nephropathy
- Chronic Kidney Disease (CKD)≤3 stage（Glomerular Filtration Rate (GFR)≥30ml/min）and 24 hour urinary protein≥3g
- Voluntarily participated in the study and signed an informed consent
Key exclusion criteria (5 listed)
- Combined life-threatening complications such as serious infection
- Abnormal glucose metabolism
- Patients with malignant tumors or malignancy , HIV infection and a history of mental illness , acute central nervous system disease , serious gastrointestinal diseases,etc
- Pregnancy or breast-feeding women
- Undergoing other clinical trials
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 |
|---|---|---|
| The Comprehensive Treatment Regimen of Traditional Chinese MedicineAlso: ShenQiMoShen Decoction, HuoXueTongMai Capsule, HeiLiaoDou Particle①ShenQiMoShen Decoction: which plays vital therapeutic effect in the CTR,the dosage is 150ml per serving and two services per day.Dosage and administration:150ml per time,twice per day ②HuoXueTongMai Capsule : which plays a vital role of promoting blood circulation and removing blood stasis. Its main components are the leeches. Dosage and administration: 4 capsules 3 times daily. ③HeiLiaoDou Particle: which will be prescribed when hypoproteinemia (serum albumin concentration≤30g/L)occurred and should be stopped taking until the serum albumin is above 30g/L. Dosage and administration: 2 packages 3 times daily. | Drug | CR/CTR group, NR/CTR group |
| The immunosuppressive agentsAlso: Glucocorticoid, Cyclosporine, Cyclophosphamide, TacrolimusAccording to Kidney Disease Improving Global Outcomes (KDIGO) clinical practice guideline for glomerulonephritis | Drug | CR/IA group, NR/IA group |
Primary outcome
Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach
Time frame: one year
Screening for single-nucleotide-polymorphism as the prognostic factor for the TCM intervention of IMN patients.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Apr 2013.
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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.
Wang Lin, PHD,MD study director
Shanghai University of Traditional Chinese Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Idiopathic Membranous Nephropathy, run by Shanghai University of Traditional Chinese 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 3 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: status not confirmed, as of the sponsor's last update on 23 Apr 2013. 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?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Wang Lin, PHD (86-13816583673, happytlynn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Genome-wide single-nucleotide-polymorphism of IMN patients treated by the Comprehensive Treatment Regimen or conventional approach (time frame: one year). 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 Apr 2013.