IgA Nephropathy (IgAN)NCT01269021
An Multi-site Prospective Study to Assess the Efficacy and Safety of MMF in the Treatment of Proliferative IgA Nephropathy(IgAN)
A study testing mycophenolate mofetil plus lower dose of Prednisone and Prednisone in full dose in people with IgA Nephropathy (IgAN), run by Zhi-Hong Liu, M.D. at 1 site in China.
Trial summary
In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid . Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- IgA Nephropathy (IgAN)
- What is being tested?
- mycophenolate mofetil plus lower dose of Prednisone and Prednisone in full dose
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 176 participants
- Where
- 1 siteChina
- Study dates
- Nov 2010to Apr 2014
- 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
- Patients who signed written informed consent form
- age between 18-60 years, female or male
- diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
- renal biopsy had: 10%< crescents<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis<50%,
- proteinuria>1g/24h for two times
Who cannot join
- secondary IgA Nephropathy (IgAN);
- eGFR<30ml/min/1.73m2.( MDRD formula)
- liver disfunction;
- uncontrolled hypertension
- WBC <3000/mm3
- Severe viral infection(HBV, HCV, CMV) within 3 months ofor known HIV infection.
- diabetes or obesity(BMI>28) ;
- severe infection or central nervous system symptoms.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid .
Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.
Read the detailed description
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).
- Conditions
- IgA Nephropathy (IgAN)
- Being tested
- mycophenolate mofetil plus lower dose of Prednisone, Prednisone in full dose
- Keywords
- MMF treatment IgA Nephropathy (IgAN)
- Medical subject headings
- Glomerulonephritis, IGA
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
mycophenolate mofetil plus lower dose of PrednisoneDrug
Also called MMF
MMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d
Prednisone in full doseDrug
0.8-1mg/kg/d
| Study group | Role | What they receive |
|---|---|---|
| mycophenolate mofetil | Experimental | Not described Receives: Drug: mycophenolate mofetil plus lower dose of Prednisone |
| Prednisone | Active comparator | Not described Receives: Drug: Prednisone in full dose |
What is being measured
The primary outcome is the main question the study is designed to answer.
the rate of complete remission (CR) at 6 months
Measured: 6 months
Secondary outcomes (3)
the rate of overall response (CR+ partial remission [PR]) at 6 months
Measured: 6 months
the median time to CR
Measured: from the start of enrollment to the day of complete remission
the relapse rate after stopping the treatments
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 posted4 Jan 2011 (estimated)
- Study startNov 2010
- Primary completionOct 2013
- Study completionApr 2014
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IgA Nephropathy (IgAN)Studies 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
- 176 participants (actual)
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, Nanjing, China.
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01269021
- Sponsor's protocol ID
- NJCT-1005
- Status last verified
- Mar 2016
- First submitted
- 10 Dec 2010
- Last updated
- 17 Mar 2016
- Results posted
- No
- Data monitoring committee
- Yes
Study at a glance
From the registry record, last updated by the sponsor on 17 Mar 2016. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine, Nanjing, China.
- ClinicalTrials.gov ID
- NCT01269021
- Acronym / sponsor ID
- NJCT-1005
- Conditions
- IgA Nephropathy (IgAN)
- Keywords
- MMF treatment IgA Nephropathy (IgAN)
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 176 participants (actual)
- Lead sponsor
- Zhi-Hong Liu, M.D.University, hospital or other
- Study start
- Nov 2010
- Primary completion
- Oct 2013 (actual)
- Study completion
- Apr 2014 (actual)
- First posted
- 4 Jan 2011 (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.
In order to treat proliferative IgA Nephropathy(IgAN), The investigators designed an open, prospective, randomized parallel study to access the efficacy and safety of MMF compared to corticosteroid .
Patients who fulfill the inclusion criteria will be randomized in a 1:1 ratio to either the MMF group or corticosteroid group.
Detailed description
To access the efficacy and safety of MMF compared to corticosteroid in in treatment of proliferative IgA Nephropathy(IgAN).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| mycophenolate mofetil | Experimental | Drug: mycophenolate mofetil plus lower dose of Prednisone |
| Prednisone | Active comparator | Drug: Prednisone in full dose |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (5 listed)
- Patients who signed written informed consent form
- age between 18-60 years, female or male
- diagnosed IgA Nephropathy (IgAN) by renal biopsy during 1 months
- renal biopsy had: 10%< crescents<50%; endocapillary hypercellularity; or necrosis ,and interstitial fibrosis<50%,
- proteinuria>1g/24h for two times
Key exclusion criteria (8 listed)
- secondary IgA Nephropathy (IgAN);
- eGFR<30ml/min/1.73m2.( MDRD formula)
- liver disfunction;
- uncontrolled hypertension
- WBC <3000/mm3
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 |
|---|---|---|
| mycophenolate mofetil plus lower dose of PrednisoneAlso: MMFMMF 1.0-1.5g/d*6mons Prednisone 0.4-0.6 mg/kg/d | Drug | mycophenolate mofetil |
| Prednisone in full dose0.8-1mg/kg/d | Drug | Prednisone |
Primary outcome
the rate of complete remission (CR) at 6 months
Time frame: 6 months
3 secondary outcomes
the rate of overall response (CR+ partial remission [PR]) at 6 months
Time frame: 6 months
the median time to CR
Time frame: from the start of enrollment to the day of complete remission
the relapse rate after stopping the treatments
Time frame: 12 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 17 Mar 2016.
Related trials for IgA Nephropathy (IgAN)
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A Phase 3 Blinded Study of JADE101 in Participants With Immunoglobulin A Nephropathy
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A Study to Evaluate the Efficacy and Safety of Sefaxersen (RO7434656) in Participants With Primary Immunoglobulin A (IgA) Nephropathy at High Risk of Progression
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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, Nanjing, China.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing mycophenolate mofetil plus lower dose of Prednisone and Prednisone in full dose in people with IgA Nephropathy (IgAN), 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 5 inclusion and 8 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 17 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. 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 rate of complete remission (CR) at 6 months (time frame: 6 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 Mar 2016.