Intensive supportive care plus immunosuppression in IgA nephropathy
Open accessAbstract
BACKGROUND: The outcomes of immunosuppressive therapy, when added to supportive care, in patients with IgA nephropathy are uncertain. METHODS: We conducted a multicenter, open-label, randomized, controlled trial with a two-group, parallel, group-sequential design. During a 6-month run-in phase, supportive care (in particular, blockade of the renin-angiotensin system) was adjusted on the basis of proteinuria. Patients who had persistent proteinuria with urinary protein excretion of at least 0.75 g per day were randomly assigned to receive supportive care alone (supportive-care group) or supportive care plus immunosuppressive therapy (immunosuppression group) for 3 years. The primary end points in hierarchical order were full clinical remission at the end of the trial (protein-to-creatinine ratio <0.2 [with both protein and creatinine measured in grams] and a decrease in the estimated glomerular filtration rate [eGFR] of <5 ml per minute per 1.73 m(2) of body-surface area from baseline) and a decrease in the eGFR of at least 15 ml per minute per 1.73 m(2) at the end of the trial. The primary end points were analyzed with the use of logistic-regression models. RESULTS: The run-in phase was completed by 309 of 337 patients. The proteinuria level decreased to less than 0.75 g of urinary protein excretion per day in 94 patients. Of the remaining 162 patients who consented to undergo randomization, 80 were assigned to the supportive-care group, and 82 to the immunosuppression group. After 3 years, 4 patients (5%) in the supportive-care group, as compared with 14 (17%) in the immunosuppression group, had a full clinical remission (P=0.01). A total of 22 patients (28%) in the supportive-care group and 21 (26%) in the immunosuppression group had a decrease in the eGFR of at least 15 ml per minute per 1.73 m(2) (P=0.75). There was no significant difference in the annual decline in eGFR between the two groups. More patients in the immunosuppression group than in the supportive-care group had severe infections, impaired glucose tolerance, and weight gain of more than 5 kg in the first year of treatment. One patient in the immunosuppression group died of sepsis. CONCLUSIONS: The addition of immunosuppressive therapy to intensive supportive care in patients with high-risk IgA nephropathy did not significantly improve the outcome, and during the 3-year study phase, more adverse effects were observed among the patients who received immunosuppressive therapy, with no change in the rate of decrease in the eGFR. (Funded by the German Federal Ministry of Education and Research; STOP-IgAN ClinicalTrials.gov number, NCT00554502.).
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In the STOP-IgAN trial, pooled data showed no benefits of immunosuppression on proteinuria, eGFR decline, or development of ESKD after 3 years.
“Analysis of the pooled data showed no bene fi ts of immunosuppression on proteinuria, eGFR decline, or development of ESKD after 3 years 29”
From A pre-specified analysis of the DAPA-CKD trial demonstrates the effects of dapagliflozin on major adverse kidney events in patients with IgA nephropathy (2021) · cites this paper as [29]
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Association Between Tonsillectomy and Outcomes in Patients With Immunoglobulin A Nephropathy
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Glucocorticoids in the Treatment of Glomerular Diseases
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Is immunoglobulin A nephropathy different in different ethnic populations?
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Why Target the Gut to Treat IgA Nephropathy?
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Self-citationImmunosuppressive agents for treating IgA nephropathy
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The role of BAFF and APRIL in IgA nephropathy: pathogenic mechanisms and targeted therapies
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C5a receptor inhibitor avacopan in immunoglobulin A nephropathy—an open-label pilot study
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Bellur, S. S., Lepeytre, F., Vorobyeva, O. A., Troyanov, S., Cook, H. T., Roberts, I. S. D., Alpers, C. E., Amore, A., Barratt, J., Berthoux, F. C., et al. (2016) · Kidney International · doi:10.1016/j.kint.2016.09.029 · Cited by 90 · see citing works
Chronic kidney disease care models in low- and middle-income countries: a systematic review
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Application of the International IgA Nephropathy Prediction Tool one or two years post-biopsy
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New strategies and perspectives on managing IgA nephropathy
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Is IgA nephropathy the same disease in different parts of the world?
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Secondary Immunodeficiency Related to Kidney Disease (SIDKD)—Definition, Unmet Need, and Mechanisms
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Monitoring Immune Responses in IgA Nephropathy: Biomarkers to Guide Management
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Does cyclophosphamide still play a role in glomerular diseases?
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Treatment of patients with IgA nephropathy: a call for a new paradigm
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Self-citationUrine proteomics for prediction of disease progression in patients with IgA nephropathy
Rudnicki, M., Siwy, J., Wendt, R. T., Lipphardt, M., Koziolek, M. J., Maixnerová, D., Peters, B., Kerschbaum, J., Leierer, J., Neprašová, M., et al. (2020) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfaa307 · Cited by 75 · see citing works
Long-term outcomes of IgA nephropathy in China
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Advances in Understanding of Pathogenesis and Treatment of Immune-Mediated Kidney Disease: A Review
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IgA nephropathy in adults—treatment standard
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IgA Vasculitis and IgA Nephropathy: Same Disease?
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Kwon, C. S., Daniele, P., Forsythe, A., & Ngai, C. (2021) · Journal of health economics and outcomes research · doi:10.36469/jheor.2021.26129 · Cited by 67 · see citing works
Mark, P. B., Sarafidis, P. A., Ekart, R., Ferro, C. J., Balafa, O. C., Fernández‐Fernández, B., Herrington, W. G., Rossignol, P., Vecchio, L. D., Valdivielso, J. M., et al. (2023) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfad112 · Cited by 72 · see citing works
Bortezomib for Reduction of Proteinuria in IgA Nephropathy
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Dickkopf 3—a novel biomarker of the ‘kidney injury continuum’
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Immunological drivers of IgA nephropathy: Exploring the mucosa–kidney link
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IgA1 Protease Treatment Reverses Mesangial Deposits and Hematuria in a Model of IgA Nephropathy
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A Personalized Update on IgA Nephropathy: A New Vision and New Future Challenges
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An Update on the Current State of Management and Clinical Trials for IgA Nephropathy
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Complications of Immunosuppression in Glomerular Disease
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Corticosteroids in IgA Nephropathy: Lessons from Recent Studies
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Inflammation in IgA nephropathy
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- Authors
- Rauen, T., Eitner, F., Fitzner, C., Sommerer, C., Zeier, M., Otte, B., Panzer, U., Peters, H., Benck, U., Mertens, P. R., Kuhlmann, U., Witzke, O., Gross, O., Vielhauer, V., Mann, J. F. E., Hilgers, R.-D., & Floege, J.
- Affiliations
- Heidelberg University (DE)
- RWTH Aachen University (DE)
- University Hospital Münster (DE)
- University Medical Center Hamburg-Eppendorf (DE)
- Charité – Universitätsmedizin Berlin (DE)
- Otto-von-Guericke-Universität Magdeburg (DE)
- Essen University Hospital (DE)
- Universitätsmedizin Göttingen (DE)
- LMU Klinikum (DE)
- München Klinik (DE)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2015-12-03
- Volume
- 373
- Issue
- 23
- Pages
- 2225-2236
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W2186629139
- Cited by
- 726
- References
- 33
- Citations by year
- 2026: 52 · 2025: 72 · 2024: 85 · 2023: 85 · 2022: 69 · 2021: 82 · 2020: 77 · 2019: 48 · 2018: 49 · 2017: 50 · 2016: 50 · 2015: 5
- FWCI
- 44.38
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- GoeScholar The Publication Server of the Georg-August-Universität Göttingen (Georg-August-Universität Göttingen) (submittedVersion, cc-by)
- Universitätsbibliographie, Universität Duisburg-Essen (submittedVersion)
- GRO (submittedVersion, cc-by)
- RWTH Publications (RWTH Aachen) (submittedVersion)
- Topics
- Health Sciences › Medicine › Nephrology › Renal Diseases and Glomerulopathies
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Health Sciences › Medicine › Pulmonary and Respiratory Medicine › Vasculitis and related conditions
- Keywords
- IgA nephropathy, immunosuppressive therapy, supportive care, renin-angiotensin system blockade, proteinuria, clinical remission, estimated glomerular filtration rate decline, renal function decline, impaired glucose tolerance, weight gain, kidney disease progression, urine protein-to-creatinine ratio, run-in phase
- MeSH terms
- Adult, Angiotensin-Converting Enzyme Inhibitors, Combined Modality Therapy, Critical Care, Female, Glomerular Filtration Rate, Glomerulonephritis, IGA, Glucocorticoids, Humans, Immunosuppression Therapy, Male, Middle Aged, Proteinuria, Renin-Angiotensin System, Logistic Models, Treatment Failure, Angiotensin II Type 2 Receptor Blockers
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