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A multi-center, randomized, controlled clinical trial to evaluate the short-term and long-term efficacy and safety of mycophenolate mofetil (MMF) in reducing proteinuria and preserving renal function in patients with IgAN who have pre-treated (and continue to be treated) with angiotensin II receptor blockers (ARB), compared to the corticosteroids.
There are four phases of study for each subject. Phase 1 the screening phase. During this phase each potential subject will be evaluated to determine if he/she is eligible for the study.
Phase 2 the ARB lead-in phase will last for three months. Phase 3 the intervention phase. Each subject will be randomly received 12 months treatment with the study drugs (MMF, prednisone or MMF plus prednisone) Phase 4 following-up phase. All the patients will be followed by 3 years after study drug stopped.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Pred group | Active Comparator | Pred Group: Prednisone treatment Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month. |
|
| MMF Group | Active Comparator | MMF Group: MMF treatment Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month. |
|
| Pred plus MMF Group | Active Comparator | Pred plus MMF Group: Prednisone plus MMF treatment. Patients will give methylprednisolone intravenously at a dose of 0.5 g/day for 3 days at the start of months 1, 3, and 5; then take oral prednisone (0.5 mg/kg/d) on alternate days. Prednison will be tapered 5 mg per month from the seventh month to the 12th month. Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then 0.5 bid for the remaining 6-month. |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| irbesartan | Drug | In the ARB lead-in phase, each subject will be on a strict sodium-restricted diet ( < 5 g NaCl/day), and then given a stable dose (150mg ~ 300mg/day) of irbesartan (Aprovel) for 3 months until reaching the target blood pressure (BP) level of ≤ 125/75 mmHg. Patients will continue ARB treatment in the drug treatment phase and at lease 3 years in the follow-up phase. |
| Measure | Description | Time Frame |
|---|---|---|
| Remission of proteinuria (complete or partial) | up to 4.3 years |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | every 6 month for 4.3 years(including 3 months ARB leading-in phase, 1 years' treatment phase and 3 years' follow-up) |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Xueqing Yu, MD | Department of Nephrology, 1st Affiliated Hospital, Sun Yat-Sen University | Principal Investigator |
| Yunha Liao, MD | Department of Nephrology, 1st Affiliated Hospital of Guangxi Medical University,Guangxi | Principal Investigator |
| Jinli Zhang, MD | Department of nephrology, People's Hospital of Yunnan Province | Principal Investigator |
| Junzhou Fu, MD | Department of Nephrology,1st People's Hospital of Guangzhou | Principal Investigator |
| Anping Xu, MD | Department of Nephrology, 2nd Affiliated Hospital of Sun Yet-Sen University,Guangzhou | Principal Investigator |
| Zhangsuo liu, MD | Department of Nephrology, 1st Affiliated hospital of Zhengzhou University, Henan | Principal Investigator |
| Tanqi lou, MD | Department of Nephrology, 3nd affiliated hospital of Sun yatsent university, Guangzhou | Principal Investigator |
| Li Hao, MD | Department of Nephrology, 2nd Affiliated Hospital of Anhui Medical University, Anhui | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The 1st Affiliated Hospital, Sun Yet-sen University | Guangzhou | Guangdong | 510080 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 38864363 | Derived | Alladin A, Hahn D, Hodson EM, Ravani P, Pfister K, Quinn RR, Samuel SM. Immunosuppressive therapy for IgA nephropathy in children. Cochrane Database Syst Rev. 2024 Jun 12;6(6):CD015060. doi: 10.1002/14651858.CD015060.pub2. |
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| ID | Term |
|---|---|
| D005922 | Glomerulonephritis, IGA |
| ID | Term |
|---|---|
| D005921 | Glomerulonephritis |
| D009393 | Nephritis |
| D007674 | Kidney Diseases |
| D014570 | Urologic Diseases |
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| ID | Term |
|---|---|
| D000077405 | Irbesartan |
| D008775 | Methylprednisolone |
| D011241 | Prednisone |
| C036266 | prednylidene |
| D009173 | Mycophenolic Acid |
| ID | Term |
|---|---|
| D001713 | Biphenyl Compounds |
| D001555 | Benzene Derivatives |
| D006841 | Hydrocarbons, Aromatic |
| D006844 | Hydrocarbons, Cyclic |
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|
|
| methylprednisolone (MP) or prednisone (pred) | Drug | Patients will take oral Pred ( 0.5 mg/kg/d) on alternate days, and on the first, third and fifth months of the drug treatment phase, patients will be given intravenous pulse therapy with methylprednisolone ( 0.5 g/day) for 3 successive days. And after 6 months, Pred should be tapered to be stopped until the end of the 12-month course of treatment. |
|
| mycophenolate mofetil (MMF) | Drug | Patients will take MMF 1.0g bid (wt ≥ 50kg) or 0.75g bid (wt < 50kg) for the first 6-month of drug treatment phase, then to 0.5 bid (wt ≥ 50kg) for the remaining 6-month. |
|
|
| Menghua Chen, MD | Department of Nephrology, General Hospital of Ningxia Medical University, Ningxia | Principal Investigator |
| Qinkai Chen, MD | Department of Nephrology, The First Affiliated Hospital of Nanchang University, Jiangxi | Principal Investigator |
| D052776 |
| Female Urogenital Diseases |
| D005261 | Female Urogenital Diseases and Pregnancy Complications |
| D000091642 | Urogenital Diseases |
| D052801 | Male Urogenital Diseases |
| D001327 | Autoimmune Diseases |
| D007154 | Immune System Diseases |
| D006838 |
| Hydrocarbons |
| D009930 | Organic Chemicals |
| D013141 | Spiro Compounds |
| D013777 | Tetrazoles |
| D001393 | Azoles |
| D006573 | Heterocyclic Compounds, 1-Ring |
| D006571 | Heterocyclic Compounds |
| D011083 | Polycyclic Compounds |
| D011239 | Prednisolone |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011244 | Pregnadienediols |
| D002208 | Caproates |
| D000144 | Acids, Acyclic |
| D002264 | Carboxylic Acids |
| D005227 | Fatty Acids |
| D008055 | Lipids |