IgA NephropathyNCT01879514
Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
A study testing Chinese Herb Prescription Granule plus prednisone in people with IgA Nephropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. 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?
- Chinese Herb Prescription Granule plus prednisone
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 200 participants
- Where
- 1 siteChina
- Study dates
- Jan 2010to Dec 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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
- Pathology:upon Lee's grade Ⅲ
- Age :18-60 years old.
- Gender and nationality are not limited
- Chronic Kidney Disease(CKD) Stage 3:（59 ml/min>GFR>30ml/min/1.73m2）
- 24-hour urine protein:≥1.0g.Informed consent
Who cannot join
- Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
- Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
- Patients suffering from acute or rapidly progressive glomerulonephritis
- Patients continue with active hepatitis B and abnormal liver function tests transaminase
- Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
- Abnormal glucose metabolism, fasting blood glucose more than 6.2mmol/L
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- Pregnancy or breast-feeding women
- Receiving other clinical trials
- Associated with other serious diseases and organ dysfunction
- Combined life-threatening complications such as severe infection
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrology,Longhua Hospital
Shanghai, 200032
YueYI Deng, Dr., 64385700 ext. 3222, lhkidney@hotmail.com
About this study
IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.
- Conditions
- IgA Nephropathy
- Being tested
- Chinese Herb Prescription Granule plus prednisone, Placebo
- Keywords
- IgA nephropathy, Therapy of Chinese medicine
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Chinese Herb Prescription Granule plus prednisoneDrug
Chinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule
PlaceboDrug
Placebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule
| Study group | Role | What they receive |
|---|---|---|
| Combination Group | Experimental | Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks Receives: Drug: Chinese Herb Prescription Granule plus prednisone |
| Placebo | Placebo comparator | Placebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Evaluation of renal function indicators
Measured: 12 months
Secondary outcomes (1)
24 hours urine protein
Evaluate the therapeutic effect
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 posted17 Jun 2013 (estimated)
- Study startJan 2010
- Primary completionDec 2013 (estimated)
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
- Double blind
- Who is masked
- Participant, Care provider
- Enrolment
- 200 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, RenJi Hospital
- Responsible party
- Principal investigator, yueyi deng, Shanghai University of Traditional Chinese Medicine
- Investigators
- YueYi Deng, PHD,MD, Principal investigator, Shanghai University of Traditional Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01879514
- Sponsor's protocol ID
- SHDC12010114
- Status last verified
- Jun 2013
- First submitted
- 25 Mar 2013
- Last updated
- 17 Jun 2013
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Jun 2013. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Study of Standardized Treatment of Integrative Medicine With the Severe IgA Nephropath
- ClinicalTrials.gov ID
- NCT01879514
- Acronym / sponsor ID
- SHDC12010114
- Conditions
- IgA Nephropathy
- Keywords
- IgA nephropathy, Therapy of Chinese medicine
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 200 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Shanghai 6th People's Hospital, RenJi Hospital
- Study start
- Jan 2010
- Primary completion
- Dec 2013 (estimated)
- First posted
- 17 Jun 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.
IgA nephropathy(IgAN) is the highest incidence of kidney pathology in the primary nephropathy. In terms of differences in prognosis, severe IgA nephropathy,one of the most main primary renal disease,could cause the uremia. It will be significant that early indicators of prognosis and early intervention can be normalized and the scientific criteria for judging the efficacy of great clinical can be established. The subject based on the past study,literature research and various treatment will take the method of multi-center, double-blind, randomized, control to investigate the standard treatment of severe IgA nephropathy. Otherwise the uniformity and objectivity of Traditional Chinese Medicine (TCM) will be improved by the standardization of TCM research based on the epidemiological investigation and statistical analysis. The subject will determine the efficacy of more sensitive biomarkers and establish more scientific criteria for judging the effect with the application of urine proteomics and metabolomics technologies in order to operate in the formation of the standardization program of the treatment of severe IgA nephropathy with the Integrative medicine of TCM.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, care provider)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Combination Group | Experimental | Drug: Chinese Herb Prescription Granule plus prednisoneChinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg·d, po. 48weeks |
| Placebo | Placebo comparator | Drug: PlaceboPlacebo of Chinese Herb Prescription Granule, 6g, Bid, po. 48weeks plus prednisone, 0.5mg-1mg/kg•d, po. 48weeks |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (6 listed)
- Confirmed by renal biopsy and clinical examination as primary IgA nephropathy.
- Pathology:upon Lee's grade Ⅲ
- Age :18-60 years old.
- Gender and nationality are not limited
- Chronic Kidney Disease(CKD) Stage 3:（59 ml/min>GFR>30ml/min/1.73m2）
Key exclusion criteria (10 listed)
- Patients within the past 3 months had received immunosuppressive agents or cytotoxic therapy is greater than 4 weeks
- Patients within the past 3 months who have received corticosteroids (prednisone or prednisolone) dose of more than 20mg / d up to 4 weeks
- Patients suffering from acute or rapidly progressive glomerulonephritis
- Patients continue with active hepatitis B and abnormal liver function tests transaminase
- Patients with a history of malignant tumor or malignancy, HIV infection, history of mental illness, acute central nervous system disorders, severe gastrointestinal disease, prohibiting the use of immunosuppressive agents
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 |
|---|---|---|
| Chinese Herb Prescription Granule plus prednisoneChinese Herb Prescription Granule includes ZiBuGanShen Granule and BuShenTongLuo Granule | Drug | Combination Group |
| PlaceboPlacebo includes placebo of ZiBuGanShen Granule and placebo of BuShenTongLuo Granule | Drug | Placebo |
Primary outcome
Glomerular filtration rate
Time frame: 12 months
Evaluation of renal function indicators
1 secondary outcome
24 hours urine protein
Time frame: 12 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Jun 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.
YueYi Deng, PHD,MD principal investigator
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?
A study testing Chinese Herb Prescription Granule plus prednisone in people with IgA 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 6 inclusion and 10 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 17 Jun 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. 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.
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 YUEYI DENG, Dr. (64385700 ext. 3222, lhkidney@hotmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Glomerular filtration rate (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 17 Jun 2013.