Glomerulonephritis, IGAPhase 2NCT02160132
A Controlled Study of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes.
A Phase 2 study testing Methylprednisolone(intravenously in the 1st-2nd-3rd month ) and Methylprednisolone(intravenously in the 1st-3rd-5th month) in people with Glomerulonephritis, IGA and Peripapillary Crescent, run by Sun Yat-sen University at 6 sites in China.
Trial summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus. Read more about this study
- Who is it for?
- Ages 14 to 65 years
- Conditions the study is for
- Glomerulonephritis, IGA, Peripapillary Crescent, Necrosis
- What is being tested?
- Methylprednisolone(intravenously in the 1st-2nd-3rd month ) and Methylprednisolone(intravenously in the 1st-3rd-5th month)
- Type of treatment
- Pill or oral medicine, Injection or infusion
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 180 participants
- Where
- 6 sitesChina
- Study dates
- Jun 2014to Dec 2016
- Phase
- Phase 2
- 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 14 to 65 years
- All sexes
- No healthy volunteers
- Child, Adult, Older adult
Who may be able to join
- Age 14~65 years, regardless of gender
- Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.
- Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.
- eGFR ≥ 50 ml/min/1.73 m2
- Willingness to sign an informed consent.
Who cannot join
- Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
- Rapidly progressive nephritic syndrome (crescent formation≥50%).
- Acute renal failure, including rapidly progressive IgAN.
- Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
- Date of renal biopsy exceeds more than 30 days.
- Cirrhosis, chronic active liver disease.
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- History of significant gastrointestinal disorders (e.g. severe chronic diarrhea or active peptic ulcer disease).
- Any Active systemic infection or history of serious infection within one month.
- Other major organ system disease (e.g. serious cardiovascular diseases including congestive heart failure , chronic obstructive pulmonary disease, asthma requiring oral steroid treatment or central nervous system diseases).
- Active tuberculosis
- Malignant hypertension that is difficult to be controlled by oral drugs.
- Known allergy, contraindication or intolerance to the steroids.
- Pregnancy or breast feeding at the time of entry or unwillingness to comply with measures for contraception.
- Malignant tumors
- Excessive drinking or drug abuse
- Mental aberrations
- Current or recent (within 30 days) exposure to any other investigational drugs.
Trial locations and contacts
6 sites in 1 country.
6 sites in 1 country
China6 sites, 6 recruiting
- Recruiting
Department of Nephrology,Dongguan People's Hospital
Dongguan, Guangdong, 523059
Guohui Liu, MD, 86769-28637333, liuguohui5@126.com
Guohui Liu, MD
- Recruiting
Department of Nephrology, 2nd Affiliated Hospital,Guangzhou Medical University
Guangzhou, Guangdong, 510260
Jianbo Liang, MD, 8620-34152282, boliangjian@tom.com
Jianbo Liang, MD
- Recruiting
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Zongpei Jiang, M.D. & Ph.D., 8620-38379727, jx.home@medmail.com.cn
Zongpei Jiang, M.D. & Ph.D.
- Recruiting
Department of Nephrology,Huizhou Municipal Central Hospital
Huizhou, Guangdong, 516001
Weiqiang Zhong, MD, 86752-2288288, 13809669766@126.com
Weiqiang Zhong, MD
- Recruiting
Department of Nephrology,1st Affiliated Hospital,Shenzhen University
Shenzhen, Guangdong, 518000
Yongcheng He, MD, 86755-83366388, heyongcheng@medmail.com.cn
Yongcheng He, MD
- Recruiting
Department of Nephrology,1st People's Hospital of Zhaoqing
Zhaoqing, Guangdong, 526020
Jinquan Wu, MD, 86758-2832139, zqwujq@163.com
Jinquan Wu, MD
About this study
Official title: Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
This prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.
Read the detailed description
It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.
- Being tested
- Methylprednisolone(intravenously in the 1st-2nd-3rd month ), Methylprednisolone(intravenously in the 1st-3rd-5th month)
- Medical subject headings
- Glomerulonephritis, IGA, Necrosis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Methylprednisolone(intravenously in the 1st-2nd-3rd month )Drug
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
Methylprednisolone(intravenously in the 1st-3rd-5th month)Drug
Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months.
| Study group | Role | What they receive |
|---|---|---|
| A 1-2-3Group | Experimental | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. Receives: Drug: Methylprednisolone(intravenously in the 1st-2nd-3rd month ) |
| B 1-3-5Group | Active comparator | Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. Receives: Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month) |
What is being measured
The primary outcome is the main question the study is designed to answer.
Remission of proteinuria (complete or partial)
Measured: up to 6 months
Secondary outcomes (2)
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).
Measured: up to 6 months
The longitudinal decline of kidney function(eGFR)
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Jun 2014 (estimated)
- Study startJun 2014
- Primary completionDec 2016 (estimated)
- Study completionDec 2016 (estimated)
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 Glomerulonephritis, IGAStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe sponsor's other registered studies.
- 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 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 180 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Zongpei Jiang, M.D. & Ph.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02160132
- Sponsor's protocol ID
- Usix-IgAN-001
- Status last verified
- Mar 2015
- First submitted
- 3 Jun 2014
- Last updated
- 3 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Publications
Liang M, Xiong L, Li A, Zhou J, Huang Y, Huang M, Zhang X, Shi H, Su N, Wei Y, Jiang Z. The effectiveness and safety of corticosteroid therapy for IgA nephropathy with crescents: a prospective, randomized, controlled study. BMC Nephrol. 2022 Jan 21;23(1):40. doi: 10.1186/s12882-022-02661-6.
PubMed 35062886
Study at a glance
From the registry record, last updated by the sponsor on 3 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect and Security of Steroids Therapy for Patients of IgA Nephropathy With Active Pathological Changes : A Prospective, Randomized, Controlled, Multi-Center Clinical Trial.
- ClinicalTrials.gov ID
- NCT02160132
- Acronym / sponsor ID
- Usix-IgAN-001
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 180 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jun 2014
- Primary completion
- Dec 2016 (estimated)
- Study completion
- Dec 2016 (estimated)
- First posted
- 10 Jun 2014 (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 prospective, randomized, controlled, multi-center clinical trial will evaluate the effect and security of steroids therapy for patients of IgA nephropathy with active pathological changes,including crescents,necrosis and microthrombus.
Detailed description
It has been reported that for urinary protein excretion that is persistently more than 1g/24h and eGFR>50ml/min/1.73m2 in IgA nephropathy(IgAN), the KDIGO guidelines suggest a 6-month course of glucocorticoids. The famous study by Pozzi C has proved that for patients of IgAN with proteinuria of 1.0-3.5g/24h and serum creatinine concentrations of 133 umol/L or less, a 6-month course of steroid treatment(1g/d methylprednisolone intravenously for 3 consecutive days,with the course repeated 2 months and 4 months later,then oral prednisone 0.5mg/kg/d on alternate days for 6 months) could significantly reduce proteinuria and protect against renal function deterioration in IgAN. Furthermore, as we know, active pathological changes in IgAN,including crescents,necrosis and microthrombus,which may turn fibrosis after three months would effect the prognosis.This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-2nd-3rd month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days Patients in control group will receive 0.5g/d methylprednisolone intravenously for 3 consecutive days in the 1st-3rd-5th month ,then oral methylprednisolone 0.4mg/kg/d on consecutive days. After followed-up for 6 months, the curative effect of steroid therapy on proteinuria and the progression of IgAN will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 1-2-3Group | Experimental | Drug: Methylprednisolone(intravenously in the 1st-2nd-3rd month )Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
| B 1-3-5Group | Active comparator | Drug: Methylprednisolone(intravenously in the 1st-3rd-5th month)Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. |
Who may qualify
- Ages
- 14 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Child, Adult, Older adult
Key inclusion criteria (5 listed)
- Age 14~65 years, regardless of gender
- Clinical evaluation and renal biopsy diagnostic for IgA nephropathy, presenting with active pathological changes,including cellular crescents,necrosis and microthrombus.
- Average urinary protein excretion of 0.5~3.5g/24h on two successive examinations.
- eGFR ≥ 50 ml/min/1.73 m2
- Willingness to sign an informed consent.
Key exclusion criteria (17 listed)
- Secondary IgAN such as systemic lupus erythematosus, Henoch-Schonlein purpuric nephritis and hepatitis B -associated nephritis.
- Rapidly progressive nephritic syndrome (crescent formation≥50%).
- Acute renal failure, including rapidly progressive IgAN.
- Current or recent (within 30 days) exposure to high-dose of steroids or immunosuppressive therapy (CTX、MMF、CsA、FK506).
- Date of renal biopsy exceeds more than 30 days.
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 |
|---|---|---|
| Methylprednisolone(intravenously in the 1st-2nd-3rd month )Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-2nd-3rd month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. | Drug | A 1-2-3Group |
| Methylprednisolone(intravenously in the 1st-3rd-5th month)Methylprednisolone 0.5g/d intravenously for 3 consecutive days in the 1st-3rd-5th month ,and oral methylprednisolone 0.4mg/kg/d on consecutive days for 6 months. | Drug | B 1-3-5Group |
Primary outcome
Remission of proteinuria (complete or partial)
Time frame: up to 6 months
2 secondary outcomes
Deterioration of renal function (evidenced by a 50% rise from baseline serum creatinine (SCr) levels, or a 25% decline from baseline eGFR levels, or onset of end-stage renal disease or dialysis treatment, or kidney transplantation).
Time frame: up to 6 months
The longitudinal decline of kidney function(eGFR)
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 3 Mar 2015.
- Derived from this study: PubMed 35062886Liang M, Xiong L, Li A, Zhou J, Huang Y, Huang M, Zhang X, Shi H, Su N, Wei Y, Jiang Z. The effectiveness and safety of corticosteroid therapy for IgA nephropathy with crescents: a prospective, randomized, controlled study. BMC Nephrol. 2022 Jan 21;23(1):40. doi: 10.1186/s12882-022-02661-6.
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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.
Zongpei Jiang, M.D. & Ph.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
6 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing Methylprednisolone(intravenously in the 1st-2nd-3rd month ) and Methylprednisolone(intravenously in the 1st-3rd-5th month) in people with Glomerulonephritis, IGA and Peripapillary Crescent, run by Sun Yat-sen University at 6 sites 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 17 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 3 Mar 2015. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 6 sites 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.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
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 Zongpei Jiang, M.D. & Ph.D. (8620-38379727, jx.home@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Remission of proteinuria (complete or partial) (time frame: up to 6 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 NCT02160132, 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 3 Mar 2015.