IgA NephropathyNCT01451710
The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
A study testing Prednisone or Prednisolone in people with IgA Nephropathy, run by Nanjing University School of Medicine at 1 site in China.
Trial summary
This is a single center,prospective,no-controlled clinical trial Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- IgA Nephropathy
- What is being tested?
- Prednisone or Prednisolone
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 30 participants
- Where
- 1 siteChina
- Study dates
- Mar 2011to May 2012
- 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
- Female or male patients aged between 18 to 65 years
- Renal biopsy was used to diagnose IgA nephropathy
- Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L
Who cannot join
- Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
- urine RBC > 1 million/ml
- Patients who have received treatment of enough steroids for more than 12 weeks
- patients with secondary IgA
- Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
- Patients with 2 type diabetes or obesity, whose BMI is more than 28kg/m2
Trial locations and contacts
1 site in 1 country.
China1 site
Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
Nanjing, Jiangsu
About this study
This is a single center,prospective,no-controlled clinical trial
Read the detailed description
- The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
- The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
- Conditions
- IgA Nephropathy
- Being tested
- Prednisone or Prednisolone
- Keywords
- enough steroids, MCD, efficacy
- Medical subject headings
- Glomerulonephritis, IGA, Macular dystrophy, corneal type 1
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Prednisone or PrednisoloneDrug
Also called Prednisone, prednisolone, corticosteroids
daily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day
| Study group | Role | What they receive |
|---|---|---|
| Prednisone or Prednisolone | Experimental | Not described Receives: Drug: Prednisone or Prednisolone |
What is being measured
The primary outcome is the main question the study is designed to answer.
24h urinary protein excretion
Measured: 3 months
Secondary outcomes (1)
remission rate
Measured: 3 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted14 Oct 2011 (estimated)
- Study startMar 2011
- Primary completionMay 2012
- Study completionMay 2012
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- 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
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 30 participants (actual)
Sponsor and investigators
- Lead sponsor
- Nanjing University School of Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zhi-Hong Liu, M.D., Nanjing University School of Medicine
- Investigators
- Zhihong Liu, MD, Study director, Research Institute of Nephrology, Jinling Hospital, Nanjing University School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01451710
- Sponsor's protocol ID
- NJCT-1102
- Status last verified
- Jul 2012
- First submitted
- 7 Oct 2011
- Last updated
- 10 Jul 2012
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.
PubMed 23787555
Study at a glance
From the registry record, last updated by the sponsor on 10 Jul 2012. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Effectiveness of Enough Steroids as Inducement Therapy in Minimal Change Disease-like IgA Nephropathy
- ClinicalTrials.gov ID
- NCT01451710
- Acronym / sponsor ID
- NJCT-1102
- Conditions
- IgA Nephropathy
- Keywords
- enough steroids, MCD, efficacy
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 30 participants (actual)
- Lead sponsor
- Nanjing University School of MedicineUniversity, hospital or other
- Study start
- Mar 2011
- Primary completion
- May 2012 (actual)
- Study completion
- May 2012 (actual)
- First posted
- 14 Oct 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.
This is a single center,prospective,no-controlled clinical trial
Detailed description
- The complete remission of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
- The safety of enough steroids as inducement therapy in adult minimal change disease-like IgA nephropathy patients
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Prednisone or Prednisolone | Experimental | Drug: Prednisone or Prednisolone |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (3 listed)
- Female or male patients aged between 18 to 65 years
- Renal biopsy was used to diagnose IgA nephropathy
- Patients with 24h proteinuria 3.5g and serum albumin concentration lower than 30g/L
Key exclusion criteria (6 listed)
- Patients with serum creatinine ≥ 3 mg/dl or eGFR < 30ml/min per 1.73 m2
- urine RBC > 1 million/ml
- Patients who have received treatment of enough steroids for more than 12 weeks
- patients with secondary IgA
- Patients who have impaired liver function,with ALT/GPT or AST/GOT twice more than the normal upper limit or who have active hepatitis
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 |
|---|---|---|
| Prednisone or PrednisoloneAlso: Prednisone, prednisolone, corticosteroidsdaily single dose of 1mg/kg (maximum 80mg) or alternate day single dose of 2mg/kg (maximum 120mg),maintained for a minimum period of 6 weeks and maximum period of 12 weeks. After achieving complete remission., corticosteroids should be tapered slowly, 10mg every two weeks tapered to reach 0.15mg/kg/d, then 2.5mg every two to four weeks tapered to reach the minimum dosage 10mg/ alternate day | Drug | Prednisone or Prednisolone |
Primary outcome
24h urinary protein excretion
Time frame: 3 months
1 secondary outcome
remission rate
Time frame: 3 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 10 Jul 2012.
- Derived from this study: PubMed 23787555Wang J, Juan C, Huang Q, Zeng C, Liu Z. Corticosteroid therapy in IgA nephropathy with minimal change-like lesions: a single-centre cohort study. Nephrol Dial Transplant. 2013 Sep;28(9):2339-45. doi: 10.1093/ndt/gft211. Epub 2013 Jun 19.
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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, MD study director
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 Prednisone or Prednisolone in people with IgA Nephropathy, run by Nanjing University School of 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 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 10 Jul 2012. 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?
24h urinary protein excretion (time frame: 3 months). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01451710, which also lists 1 linked publication.
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 10 Jul 2012.