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  1. Book: Optimal treatment of anemia in nephrology

    Rossert, Jérôme

    outcome ot the OPTA (Optimal Treatment of Anemia) working groups

    (Nephrology, dialysis, transplantation ; 22, Suppl. 3)

    2007  

    Author's details guest ed. Jerome Rossert
    Series title Nephrology, dialysis, transplantation ; 22, Suppl. 3
    Collection
    Language English
    Size iii26 S.
    Publisher Oxford Univ. Press
    Publishing place Oxford
    Publishing country Great Britain
    Document type Book
    HBZ-ID HT015194281
    Database Catalogue ZB MED Medicine, Health

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    In stock of ZB MED Cologne/Königswinter

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    Zs A 2198 -22,Suppl.3- not available for loan Zeitschriften-Lesesaal

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  2. Book: Masterclass in nephrology - antibody mediated pure red cell aplasia

    Rossert, Jérôme

    lessons and challenges in the treatment of anaemia ; 24 - 25th September 2004, Cannes, France

    (Nephrology, dialysis, transplantation ; 20, Suppl. 4)

    2005  

    Author's details guest ed. Jérôme Rossert
    Series title Nephrology, dialysis, transplantation ; 20, Suppl. 4
    Collection
    Language English
    Size 36 S. : Ill., graph. Darst.
    Publisher Oxford Univ. Press
    Publishing place Oxford
    Publishing country Great Britain
    Document type Book
    HBZ-ID HT014381225
    Database Catalogue ZB MED Medicine, Health

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  3. Book: Renal epithelial cells

    Rossert, Jérôme

    differentiation and plasticity ; [Fifth Journées Gabriel Richet, Entitled "Renal Epithelial Cells: Differentiation and Plasticity", was held in Le Coudray Montceaux near Paris on June 14 to 15, 2002]

    (Journal of the American Society of Nephrology ; 14,6 Suppl. 1)

    2003  

    Institution Journées Gabriel Richet
    Author's details guest ed.: Jerome Rossert
    Series title Journal of the American Society of Nephrology ; 14,6 Suppl. 1
    Collection
    Language English
    Size S61 : Ill., graph. Darst.
    Publisher Lippincott Williams & Wilkins
    Publishing place Hagerstown, MD
    Publishing country United States
    Document type Book
    HBZ-ID HT013702725
    Database Catalogue ZB MED Medicine, Health

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    Zs A 3344 -14,Suppl.1- not available for loan Zeitschriften-Lesesaal

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  4. Article: Le patient diabétique: un insuffisant rénal comme les autres?

    Rossert, Jérôme

    Nephrologie & therapeutique

    2006  Volume 2 Suppl 3, Page(s) S187–9

    Abstract: The number of patients requiring renal replacement therapy because of diabetic nephropathy has been relentlessly increasing, and diabetes mellitus is now the leading cause of end stage renal disease in most Western Countries. Diabetic nephropathy has ... ...

    Title translation The diabetic patient: renal insufficiency like other kidney failures?.
    Abstract The number of patients requiring renal replacement therapy because of diabetic nephropathy has been relentlessly increasing, and diabetes mellitus is now the leading cause of end stage renal disease in most Western Countries. Diabetic nephropathy has specificities. First, it tends to progress rapidly toward end stage renal disease. Second, patients with diabetic nephropathy are at increased risk of cardiovascular disease, when compared to patients with non diabetic nephropathy; similarly to what has been shown for diabetic patients on dialysis. Third, patients with diabetic nephropathy tend to be more severely anemic than patients with non-diabetic chronic kidney disease. Finally, small studies suggest that patients with diabetic nephropathy could have lower serum concentrations of parathyroid hormone than patients with non-diabetic nephropathy and similar glomerular filtration rate.
    MeSH term(s) Biomarkers/blood ; Diabetic Nephropathies/blood ; Diabetic Nephropathies/complications ; Diabetic Nephropathies/therapy ; Humans ; Kidney Failure, Chronic/etiology ; Parathyroid Hormone/blood ; Renal Replacement Therapy
    Chemical Substances Biomarkers ; Parathyroid Hormone
    Language French
    Publishing date 2006-05
    Publishing country France
    Document type English Abstract ; Journal Article ; Review
    ZDB-ID 2229575-6
    ISSN 1872-9177 ; 1769-7255
    ISSN (online) 1872-9177
    ISSN 1769-7255
    Database MEDical Literature Analysis and Retrieval System OnLINE

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  5. Article ; Online: EMEA guidelines on biosimilars and their clinical implications.

    Rossert, Jerome

    Kidney & blood pressure research

    2007  Volume 30 Suppl 1, Page(s) 13–17

    MeSH term(s) Animals ; Drug Evaluation, Preclinical/standards ; Drugs, Generic/standards ; Europe ; Guidelines as Topic/standards ; Humans ; Randomized Controlled Trials as Topic/standards ; Therapeutic Equivalency
    Chemical Substances Drugs, Generic
    Language English
    Publishing date 2007
    Publishing country Switzerland
    Document type Journal Article ; Review
    ZDB-ID 1326018-2
    ISSN 1423-0143 ; 1420-4096
    ISSN (online) 1423-0143
    ISSN 1420-4096
    DOI 10.1159/000107276
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1458: Show issues Location:
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    Jg. 1995 - 2021: Lesesall (1.OG)
    ab Jg. 2022: Lesesaal (EG)

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  6. Article: Erythropoietin-induced, antibody-mediated pure red cell aplasia.

    Rossert, Jérôme

    European journal of clinical investigation

    2005  Volume 35 Suppl 3, Page(s) 95–99

    Abstract: Pure red cell aplasia (PRCA) is a rare haematological condition that is characterized by severe aregenerative anaemia due to an almost complete cessation of red blood cell production. While antibody-mediated PRCA was extremely rare before 1998, the ... ...

    Abstract Pure red cell aplasia (PRCA) is a rare haematological condition that is characterized by severe aregenerative anaemia due to an almost complete cessation of red blood cell production. While antibody-mediated PRCA was extremely rare before 1998, the incidence of this disorder increased sharply after 1998 in patients receiving subcutaneous epoetin alfa produced by Ortho-Biotech and marketed outside the USA. The diagnosis of antibody-mediated PRCA relies mostly on the results of bone marrow biopsy or aspirate, which shows an absence of erythroid precursors and/or red cell maturation arrest while counts of white cell and platelet precursors are normal, and on the identification of circulating anti-erythropoietin antibodies. Retrospective analysis of PRCA cases has shown that immunosuppressive therapy can induce a disappearance of anti-erythropoietin antibodies in most patients. Eur J Clin Invest 2005; 35 (Suppl. 3): 95-99.
    MeSH term(s) Antibodies/immunology ; Blood Cell Count ; Epoetin Alfa ; Erythrocytes/immunology ; Erythropoietin/adverse effects ; Erythropoietin/immunology ; Hematinics/adverse effects ; Humans ; Immunosuppressive Agents/therapeutic use ; Recombinant Proteins ; Red-Cell Aplasia, Pure/drug therapy ; Red-Cell Aplasia, Pure/epidemiology ; Red-Cell Aplasia, Pure/immunology
    Chemical Substances Antibodies ; Hematinics ; Immunosuppressive Agents ; Recombinant Proteins ; Erythropoietin (11096-26-7) ; Epoetin Alfa (64FS3BFH5W)
    Language English
    Publishing date 2005-12
    Publishing country England
    Document type Journal Article ; Review
    ZDB-ID 186196-7
    ISSN 1365-2362 ; 0014-2972 ; 0960-135X
    ISSN (online) 1365-2362
    ISSN 0014-2972 ; 0960-135X
    DOI 10.1111/j.1365-2362.2005.01536.x
    Database MEDical Literature Analysis and Retrieval System OnLINE

    Full text online

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    Zs.A 677: Show issues Location:
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  7. Article ; Online: Validity and Utility of a Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression: A Review.

    Little, Dustin J / Gasparyan, Samvel B / Schloemer, Patrick / Jongs, Niels / Brinker, Meike / Karpefors, Martin / Tasto, Christoph / Rethemeier, Nicole / Frison, Lars / Nkulikiyinka, Richard / Rossert, Jerome / Heerspink, Hiddo J L

    Journal of the American Society of Nephrology : JASN

    2023  Volume 34, Issue 12, Page(s) 1928–1935

    Abstract: Clinical trials in nephrology often use composite end points comprising clinical events, such as onset of ESKD and initiation of kidney function replacement therapy, along with a sustained large ( e.g. , ≥50%) decrease in GFR. Such events typically occur ...

    Abstract Clinical trials in nephrology often use composite end points comprising clinical events, such as onset of ESKD and initiation of kidney function replacement therapy, along with a sustained large ( e.g. , ≥50%) decrease in GFR. Such events typically occur late in the disease course, resulting in large trials in which most participants do not contribute clinical events. In addition, components of the end point are considered of equal importance; however, their clinical significance varies. For example, kidney function replacement therapy initiation is likely to be clinically more meaningful than GFR decline of ≥50%. By contrast, hierarchical composite end points (HCEs) combine multiple outcomes and prioritize each patient's most clinically relevant outcome for inclusion in analysis. In this review, we consider the use of HCEs in clinical trials of CKD progression, emphasizing the potential to combine dichotomous clinical events such as those typically used in CKD progression trials, with the continuous variable of GFR over time, while ranking all components according to clinical significance. We consider maraca plots to visualize overall treatment effects and the contributions of individual components, discuss the application of win odds in kidney HCE trials, and review general design considerations for clinical trials for CKD progression with kidney HCE as an efficacy end point.
    MeSH term(s) Humans ; Renal Insufficiency, Chronic ; Glomerular Filtration Rate ; Kidney ; Disease Progression
    Chemical Substances HCE (4479-32-7)
    Language English
    Publishing date 2023-10-09
    Publishing country United States
    Document type Review ; Journal Article ; Research Support, Non-U.S. Gov't
    ZDB-ID 1085942-1
    ISSN 1533-3450 ; 1046-6673
    ISSN (online) 1533-3450
    ISSN 1046-6673
    DOI 10.1681/ASN.0000000000000244
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3344: Show issues Location:
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  8. Article ; Online: Development and Validation of a New Hierarchical Composite End Point for Clinical Trials of Kidney Disease Progression.

    Heerspink, Hiddo J L / Jongs, Niels / Schloemer, Patrick / Little, Dustin J / Brinker, Meike / Tasto, Christoph / Karpefors, Martin / Wheeler, David C / Bakris, George / Perkovic, Vlado / Nkulikiyinka, Richard / Rossert, Jerome / Gasparyan, Samvel B

    Journal of the American Society of Nephrology : JASN

    2023  Volume 34, Issue 12, Page(s) 2025–2038

    Abstract: Significance statement: The established composite kidney end point in clinical trials combines clinical events with sustained large changes in GFR but does not weigh the relative clinical importance of the end point components. By contrast, a ... ...

    Abstract Significance statement: The established composite kidney end point in clinical trials combines clinical events with sustained large changes in GFR but does not weigh the relative clinical importance of the end point components. By contrast, a hierarchical composite end point (HCE) accounts for the clinical importance of the end point components. The authors developed and validated a kidney HCE that combines clinical kidney outcomes with longitudinal GFR changes (GFR slope). They demonstrate that in seven major placebo-controlled kidney outcome trials with different medications, treatment effect estimates on the HCE were consistently in similar directions and of similar magnitudes compared with treatment effects on the established kidney end point. The HCE's prioritization of clinical outcomes and ability to combine dichotomous outcomes with GFR slope make it an attractive alternative to the established kidney end point.
    Background: The established composite kidney end point in clinical trials combines clinical events with sustained large changes in GFR. However, the statistical method does not weigh the relative clinical importance of the end point components. A HCE accounts for the clinical importance of the end point components and enables combining dichotomous outcomes with continuous measures.
    Methods: We developed and validated a new HCE for kidney disease progression, performing post hoc analyses of seven major Phase 3 placebo-controlled trials that assessed the effects of canagliflozin, dapagliflozin, finerenone, atrasentan, losartan, irbesartan, and aliskiren in patients with CKD. We calculated the win odds (WOs) for treatment effects on a kidney HCE, defined as a hierarchical composite of all-cause mortality; kidney failure; sustained 57%, 50%, and 40% GFR declines from baseline; and GFR slope. The WO describes the odds of a more favorable outcome for receiving the active compared with the control. We compared the WO with the hazard ratio (HR) of the primary kidney outcome of the original trials.
    Results: In all trials, treatment effects calculated with the WO reflected a similar direction and magnitude of the treatment effect compared with the HR. Clinical trials incorporating the HCE would achieve increased statistical power compared with the established composite end point at equivalent sample sizes.
    Conclusions: In seven major kidney clinical trials, the WO and HR provided similar direction of treatment effect estimates with smaller HRs associated with larger WOs. The prioritization of clinical outcomes and inclusion of broader composite end points makes the HCE an attractive alternative to the established kidney end point.
    MeSH term(s) Humans ; Renal Insufficiency, Chronic/drug therapy ; Glomerular Filtration Rate ; Kidney ; Disease Progression
    Chemical Substances HCE (4479-32-7)
    Language English
    Publishing date 2023-10-24
    Publishing country United States
    Document type Journal Article ; Research Support, N.I.H., Extramural
    ZDB-ID 1085942-1
    ISSN 1533-3450 ; 1046-6673
    ISSN (online) 1533-3450
    ISSN 1046-6673
    DOI 10.1681/ASN.0000000000000243
    Database MEDical Literature Analysis and Retrieval System OnLINE

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    Zs.A 3344: Show issues Location:
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  9. Article: EMEA Guidelines on Biosimilars and Their Clinical Implications

    Rossert, Jerome

    Kidney and Blood Pressure Research

    2007  Volume 30, Issue 1, Page(s) 13–17

    Institution Amgen Global Safety, Thousand Oaks, Calif., USA
    Language English
    Publishing date 2007-08-27
    Publisher S. Karger AG
    Publishing place Basel, Switzerland
    Document type Article
    Note Paper
    ZDB-ID 1326018-2
    ISBN 978-3-8055-8396-1 ; 978-3-8055-8397-8 ; 3-8055-8396-6 ; 3-8055-8397-4
    ISSN 1423-0143 ; 1420-4096
    ISSN (online) 1423-0143
    ISSN 1420-4096
    DOI 10.1159/000107276
    Database Karger publisher's database

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    In stock of ZB MED Cologne/Königswinter

    Zs.A 1458: Show issues Location:
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  10. Book ; Conference proceedings: Renal epithelial cells: differentiation and plasticity

    Rossert, Jerome

    [The Fifth Journées Gabriel Richet Entitled Renal Epithelial Cells: Differentiation and Plasticity ... held in Le Coudray Montceaux near Paris on June 14 to 15, 2002]

    (Journal of the American Society of Nephrology ; 14.2003, Suppl. 1)

    2003  

    Institution Journées Gabriel Richet
    Event/congress Journées Gabriel Richet (5, 2002.06.14-15, LeCoudrayMontceaux) ; Journées Gabriel Richet Entitled Renal Epithelial Cells: Differentiation and Plasticity (2002.06.14-15, LeCoudrayMontceaux)
    Author's details guest ed.: Jerome Rossert
    Series title Journal of the American Society of Nephrology ; 14.2003, Suppl. 1
    Language English
    Size S61 S, Ill., graph. Darst
    Publisher Lippincott Williams & Wilkins
    Publishing place Hagerstown, Md
    Document type Book ; Conference proceedings
    Note Literaturangaben
    Database Former special subject collection: coastal and deep sea fishing

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