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Intensive Supportive Care plus Immunosuppression in IgA Nephropathy

Standard

Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. / 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; STOP-IgAN Investigators.

in: NEW ENGL J MED, Jahrgang 373, Nr. 23, 03.12.2015, S. 2225-36.

Publikationen: SCORING: Beitrag in Fachzeitschrift/Zeitung › SCORING: Zeitschriftenaufsatz › Forschung › Begutachtung

Harvard

Rauen, T, Eitner, F, Fitzner, C, Sommerer, C, Zeier, M, Otte, B, Panzer, U, Peters, H, Benck, U, Mertens, PR, Kuhlmann, U, Witzke, O, Gross, O, Vielhauer, V, Mann, JFE, Hilgers, R-D, Floege, J & STOP-IgAN Investigators 2015, 'Intensive Supportive Care plus Immunosuppression in IgA Nephropathy', NEW ENGL J MED, Jg. 373, Nr. 23, S. 2225-36. https://doi.org/10.1056/NEJMoa1415463

APA

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., & STOP-IgAN Investigators (2015). Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. NEW ENGL J MED, 373(23), 2225-36. https://doi.org/10.1056/NEJMoa1415463

Vancouver

Rauen T, Eitner F, Fitzner C, Sommerer C, Zeier M, Otte B et al. Intensive Supportive Care plus Immunosuppression in IgA Nephropathy. NEW ENGL J MED. 2015 Dez 3;373(23):2225-36. https://doi.org/10.1056/NEJMoa1415463

Bibtex

@article{28b20dc3d2b1421e8fa4451e03d6225c,
title = "Intensive Supportive Care plus Immunosuppression in IgA Nephropathy",
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.).",
keywords = "Adult, Angiotensin II Type 2 Receptor Blockers, Angiotensin-Converting Enzyme Inhibitors, Combined Modality Therapy, Critical Care, Female, Glomerular Filtration Rate, Glomerulonephritis, IGA, Glucocorticoids, Humans, Immunosuppression, Logistic Models, Male, Middle Aged, Proteinuria, Renin-Angiotensin System, Treatment Failure",
author = "Thomas Rauen and Frank Eitner and Christina Fitzner and Claudia Sommerer and Martin Zeier and Britta Otte and Ulf Panzer and Harm Peters and Urs Benck and Mertens, {Peter R} and Uwe Kuhlmann and Oliver Witzke and Oliver Gross and Volker Vielhauer and Mann, {Johannes F E} and Ralf-Dieter Hilgers and J{\"u}rgen Floege and {STOP-IgAN Investigators}",
year = "2015",
month = dec,
day = "3",
doi = "10.1056/NEJMoa1415463",
language = "English",
volume = "373",
pages = "2225--36",
journal = "NEW ENGL J MED",
issn = "0028-4793",
publisher = "Massachussetts Medical Society",
number = "23",

}

RIS

TY - JOUR

T1 - Intensive Supportive Care plus Immunosuppression in IgA Nephropathy

AU - Rauen, Thomas

AU - Eitner, Frank

AU - Fitzner, Christina

AU - Sommerer, Claudia

AU - Zeier, Martin

AU - Otte, Britta

AU - Panzer, Ulf

AU - Peters, Harm

AU - Benck, Urs

AU - Mertens, Peter R

AU - Kuhlmann, Uwe

AU - Witzke, Oliver

AU - Gross, Oliver

AU - Vielhauer, Volker

AU - Mann, Johannes F E

AU - Hilgers, Ralf-Dieter

AU - Floege, Jürgen

AU - STOP-IgAN Investigators

PY - 2015/12/3

Y1 - 2015/12/3

N2 - 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.).

AB - 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.).

KW - Adult

KW - Angiotensin II Type 2 Receptor Blockers

KW - Angiotensin-Converting Enzyme Inhibitors

KW - Combined Modality Therapy

KW - Critical Care

KW - Female

KW - Glomerular Filtration Rate

KW - Glomerulonephritis, IGA

KW - Glucocorticoids

KW - Humans

KW - Immunosuppression

KW - Logistic Models

KW - Male

KW - Middle Aged

KW - Proteinuria

KW - Renin-Angiotensin System

KW - Treatment Failure

U2 - 10.1056/NEJMoa1415463

DO - 10.1056/NEJMoa1415463

M3 - SCORING: Journal article

C2 - 26630142

VL - 373

SP - 2225

EP - 2236

JO - NEW ENGL J MED

JF - NEW ENGL J MED

SN - 0028-4793

IS - 23

ER -