Primary IgA NephropathyNCT02712697
Integrative Medicine of IgA Nephropathy
A study testing WM (Shentong Granules) and Hormone (prednisone) in people with Primary IgA Nephropathy, run by Shanghai University of Traditional Chinese Medicine at 1 site in China.
Trial summary
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Read more about this study
- Who is it for?
- Ages 18 to 70 years
- Conditions the study is for
- Primary IgA Nephropathy
- What is being tested?
- WM (Shentong Granules) and Hormone (prednisone)
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 140 participants
- Where
- 1 siteChina
- Study dates
- Jun 2016to Dec 2017
- 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 70 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
- TCM is liver kidney yin deficiency syndrome;
- age 18-70 years old, sex, nationality is not limited;
- CKD phase 2-4 （89 ml/min>eGFR（EPI Formula）>15ml/min/1.73m2）;
- 24 hour urinary protein≥1g.
Who cannot join
- It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
- It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
- Acute or progressive glomerulonephritis patients;
- Severe complications threat to life, such as severe infection;
- Active hepatitis B and liver function test sustained abnormal;
- Patients with malignant tumor or have a history of cancer, HIV infection, history of mental illness, acute central nervous system diseases, severe gastrointestinal diseases, prohibition of the use of hormone;
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- Abnormal glucose metabolism, fasting blood glucose over 6.2mmol/L;
- Gravid or lactation woman;
- Other clinical trials are being studied;
- Merger with other serious disease and dysfunction of the organ.
Trial locations and contacts
1 site in 1 country.
China1 site
Department of Nephrology,Longhua Hospital
Shanghai, 200032
YueYI Deng, Dr., 64385700 ext. 3222, lhkidney@hotmail.com
About this study
Official title: Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
Read the detailed description
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
- Conditions
- Primary IgA Nephropathy
- Being tested
- WM (Shentong Granules), Hormone (prednisone)
- Keywords
- liver-kidney yin deficiency syndrome, primary severe IgA nephropathy, Lee's grade Ⅲ
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
WM (Shentong Granules)Drug
Also called Shentong Granules
Shentong Granules with Prednisone
Hormone (prednisone)Drug
Also called prednisone
Oral prednisone
| Study group | Role | What they receive |
|---|---|---|
| WM Group | Experimental | Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months Receives: Drug: WM (Shentong Granules); Drug: Hormone (prednisone) |
| Hormone Group | Placebo comparator | Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months Receives: Drug: Hormone (prednisone) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Glomerular filtration rate
Measured: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
Secondary outcomes (4)
24-hour urinary protein excretion
Measured: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
serum creatinine
Measured: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
serum Lipid
Measured: Half-yearly
TCM syndrome score
Measured: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted18 Mar 2016 (estimated)
- Study startJun 2016
- Primary completionDec 2017 (estimated)
- Study completionDec 2017 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Primary 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, Investigator
- Enrolment
- 140 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02712697
- Sponsor's protocol ID
- ZY3- CCCX-2-1002
- Status last verified
- Nov 2015
- First submitted
- 17 Nov 2015
- Last updated
- 18 Mar 2016
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 18 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Shentong Granules Plus Prednisone on Patients With Severe IgA Nephropathy(Ying-deficiency of the Liver and Kidney Pattern): a Randomized, Double-blind,Placebo-controlled Multicentre Clinical Trial
- ClinicalTrials.gov ID
- NCT02712697
- Acronym / sponsor ID
- ZY3- CCCX-2-1002
- Conditions
- Primary IgA Nephropathy
- Keywords
- liver-kidney yin deficiency syndrome, primary severe IgA nephropathy, Lee's grade Ⅲ
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 140 participants (estimated)
- Lead sponsor
- Shanghai University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- RenJi Hospital, Ruijin Hospital, Shanghai 6th People's Hospital, Xinhua Hospital, Shanghai Jiao Tong University School of Medicine, Fudan University
- Study start
- Jun 2016
- Primary completion
- Dec 2017 (estimated)
- Study completion
- Dec 2017 (estimated)
- First posted
- 18 Mar 2016 (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 present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics.
Detailed description
The present study was designed to identify the efficacy and safety of Integrative Medicine by joint oral steroid medicine on liver-kidney yin deficiency, severe IgA nephropathy. Furthermore, search for potential diagnostic predictor in IgA Nephropathy by Proteomics and Metabolomics. Combined with TCM Syndrome research, the investigators will clarify targets or mechanisms of herbal treatment. Eventually, to form a more clinically appropriate standardized combination treatment of severe IgA nephropathy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| WM Group | Experimental | Drug: WM (Shentong Granules), Drug: Hormone (prednisone)Shentong Granules, two packs, bid, P.O., 48weeks; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months |
| Hormone Group | Placebo comparator | Drug: Hormone (prednisone)Placebo ; Prednisone, 0.5-1mg/kg.d, P.O., eight to twelve weeks; then reduced to 30mg by reduce 5mg every two weeks; followed by the monthly reduction of 5mg, about 9-12 months |
Who may qualify
- Ages
- 18 to 70 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- The primary IgAN was confirmed by renal biopsy and clinical examination, and the pathological manifestations were Lee's grade and above;
- TCM is liver kidney yin deficiency syndrome;
- age 18-70 years old, sex, nationality is not limited;
- CKD phase 2-4 （89 ml/min>eGFR（EPI Formula）>15ml/min/1.73m2）;
- 24 hour urinary protein≥1g.
Key exclusion criteria (10 listed)
- It had received immunosuppressive drugs and cytotoxic therapy within the past 3 months more than 4 weeks;
- It had received corticosteroids (prednisone or prednisolone) within the past 3 months more than 20mg/d for more than up to 4 weeks;
- Acute or progressive glomerulonephritis patients;
- Severe complications threat to life, such as severe infection;
- Active hepatitis B and liver function test sustained abnormal;
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 |
|---|---|---|
| WM (Shentong Granules)Also: Shentong GranulesShentong Granules with Prednisone | Drug | WM Group |
| Hormone (prednisone)Also: prednisoneOral prednisone | Drug | Hormone Group, WM Group |
Primary outcome
Glomerular filtration rate
Time frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
4 secondary outcomes
24-hour urinary protein excretion
Time frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
serum creatinine
Time frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
serum Lipid
Time frame: Half-yearly
TCM syndrome score
Time frame: changes from Baseline to 2, 4, 12, 24,36 and 48 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 18 Mar 2016.
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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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing WM (Shentong Granules) and Hormone (prednisone) in people with Primary 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 5 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 18 Mar 2016. 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, MD. (+86-021-64385700-3226, dengyueyi@medmail.com.cn), 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: changes from Baseline to 2, 4, 12, 24,36 and 48 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 18 Mar 2016.