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Cited by 726Renal Diseases and GlomerulopathiesChronic Kidney Disease and DiabetesVasculitis and related conditions

The DOI matches its Crossref record; 33 of the 33 references it cites were found in a registry or an index.

Intensive Supportive Care plus Immunosuppression in IgA Nephropathy

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Rauen, Thomas, Eitner, Frank, Fitzner, Christina, Sommerer, Claudia, Zeier, Martin, Otte, Britta, Panzer, Ulf, Peters, Harm, Benck, Urs, Mertens, Peter R., Kuhlmann, Uwe, Witzke, Oliver, Gross, Oliver, Vielhauer, Volker, Mann, Johannes F.E., Hilgers, Ralf-Dieter, Floege, Jürgen·2015·New England Journal of Medicine
DOI 10.1056/nejmoa1415463
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Abstract

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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  1. Eitner F, 2008, J Nephrol, 21, 284
  2. International Conference on Harmonisation E9 Expert Working Group, 1999, Stat Med, 18, 1905
  3. Kanno Y, 2000, Clin Nephrol, 54, 360

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Metadata

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
DOI
10.1056/nejmoa1415463
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
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 › Rheumatology › 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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