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Currently, the treatment options of recurrent IgA nephropathy (IgAN) are conflicting and largely based on expert opinions. Consequently, the recent KDIGO clinical practice guideline for the care of kidney transplant recipients has concluded that there are no definite strategies for prevention and treatment. However, recurrent IgAN in the transplanted kidney is common and may contribute to graft loss, in particular, if cresentic formation, extra- or endocapillary proliferation were presented in kidney pathology. Herein, the investigators assume that rituximab, anti-CD20 Ab agent, can reduce circulating IgA with subsequently decrease rate of polymeric forms of IgA deposition in glomerular capillaries. Therefore, the investigators speculate that rituximab may have potential effect to reduce circulating polymeric forms of IgA and slow progression of recurrent IgAN.
Hypothesis: In kidney transplant recipients with active endocapillary proliferation pathology of recurrent IgAN, an intravenous infusion of 375mg/m2 of rituximab on 4 consecutive monthly dose is superior to conventional therapy in reducing 24-hour proteinuria, and slowing progression of recurrent IgAN.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Rituximab | Experimental | Drug: Rituximab •Rituximab 375 mg/m2 on treatment month 1, 2, 3, 4 Other Name: Mabthera |
|
| ACEI/ARB plus corticosteroids | Active Comparator | Drug: ACEI/ARB
Other Name: Enalapril, Lorsartan, Prednisolone |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Intravenous Rituximab | Drug | - 375 mg/m2 rituximab be prescribed 4 consecutive monthly |
|
| Measure | Description | Time Frame |
|---|---|---|
| Remission rate | Percentage of patients in each group achieving complete or partial response determined by proteinuria and 24-hour creatinine clearance | 12 months |
| Incidence of all adverse events | The incidence of adverse events such as serious infection, allergy, fever, headache, etc. | 12 months |
| Measure | Description | Time Frame |
|---|---|---|
| Change in allograft pathology following treatment | The difference of active and chronic score report by BANFF score, HAAS, Oxford criteria between pre-treatment and post-treatment | 12 months |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Wiwat Chancharoenthana, M.D., Ph.D. | Contact | wiwatmd@hotmail.com |
| Name | Affiliation | Role |
|---|---|---|
| Wiwat Chancharoenthana, M.D., Ph.D. | Chulalongkorn University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Chulalongkorn University | Recruiting | Bangkok | Bangkok | 10330 | Thailand |
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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 |
|---|---|
| D000069283 | Rituximab |
| D000305 | Adrenal Cortex Hormones |
| D004656 | Enalapril |
| D011239 | Prednisolone |
| ID | Term |
|---|---|
| D058846 | Antibodies, Monoclonal, Murine-Derived |
| D000911 | Antibodies, Monoclonal |
| D000906 | Antibodies |
| D007136 | Immunoglobulins |
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| ACEI/ARB and corticosteroids | Drug |
|
|
|
| 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 |
| D007162 | Immunoproteins |
| D001798 | Blood Proteins |
| D011506 | Proteins |
| D000602 | Amino Acids, Peptides, and Proteins |
| D012712 | Serum Globulins |
| D005916 | Globulins |
| D006728 | Hormones |
| D006730 | Hormones, Hormone Substitutes, and Hormone Antagonists |
| D004151 | Dipeptides |
| D009842 | Oligopeptides |
| D010455 | Peptides |
| D011246 | Pregnadienetriols |
| D011245 | Pregnadienes |
| D011278 | Pregnanes |
| D013256 | Steroids |
| D000072473 | Fused-Ring Compounds |
| D011083 | Polycyclic Compounds |