The DOI matches its Crossref record; 32 of the 32 references it cites were found in a registry or an index.
A Trial of Darbepoetin Alfa in Type 2 Diabetes and Chronic Kidney Disease
Open accessAbstract
BACKGROUND: Anemia is associated with an increased risk of cardiovascular and renal events among patients with type 2 diabetes and chronic kidney disease. Although darbepoetin alfa can effectively increase hemoglobin levels, its effect on clinical outcomes in these patients has not been adequately tested. METHODS: In this study involving 4038 patients with diabetes, chronic kidney disease, and anemia, we randomly assigned 2012 patients to darbepoetin alfa to achieve a hemoglobin level of approximately 13 g per deciliter and 2026 patients to placebo, with rescue darbepoetin alfa when the hemoglobin level was less than 9.0 g per deciliter. The primary end points were the composite outcomes of death or a cardiovascular event (nonfatal myocardial infarction, congestive heart failure, stroke, or hospitalization for myocardial ischemia) and of death or end-stage renal disease. RESULTS: Death or a cardiovascular event occurred in 632 patients assigned to darbepoetin alfa and 602 patients assigned to placebo (hazard ratio for darbepoetin alfa vs. placebo, 1.05; 95% confidence interval [CI], 0.94 to 1.17; P=0.41). Death or end-stage renal disease occurred in 652 patients assigned to darbepoetin alfa and 618 patients assigned to placebo (hazard ratio, 1.06; 95% CI, 0.95 to 1.19; P=0.29). Fatal or nonfatal stroke occurred in 101 patients assigned to darbepoetin alfa and 53 patients assigned to placebo (hazard ratio, 1.92; 95% CI, 1.38 to 2.68; P<0.001). Red-cell transfusions were administered to 297 patients assigned to darbepoetin alfa and 496 patients assigned to placebo (P<0.001). There was only a modest improvement in patient-reported fatigue in the darbepoetin alfa group as compared with the placebo group. CONCLUSIONS: The use of darbepoetin alfa in patients with diabetes, chronic kidney disease, and moderate anemia who were not undergoing dialysis did not reduce the risk of either of the two primary composite outcomes (either death or a cardiovascular event or death or a renal event) and was associated with an increased risk of stroke. For many persons involved in clinical decision making, this risk will outweigh the potential benefits. (ClinicalTrials.gov number, NCT00093015.)
Overview
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Integrity signals
Registry
Cites
Statistics
Verification
Claims the paper makes
The claims and statistics of this paper haven’t been checked yet.
Run the check — free, no account needed. It reads the open-access text and checks the sources it cites.
Claims other papers make about this one
Each is checked against this paper’s own text: does it say what the citing paper says it does?
In the citing paper
“In pre-dialysis CKD patients with or without diabetes higher Hgb targets, particularly in patients with poor initial Hgb responses, were also associated with increased cardiovascular risk.”
From Regulation of erythropoiesis by hypoxia-inducible factors (2013) · cites this paper as [229]
Self-check
Percentages, sums and reported differences re-computed from the paper’s own numbers.
The self-check needs the paper’s full text.
Citations
Cites
Brenner, B. M., Cooper, M. E., de Zeeuw, D., Keane, W. F., Mitch, W. E., Parving, H.-H., Remuzzi, G., Snapinn, S. M., Zhang, Z., & Shahinfar, S. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011161 · Cited by 7,493
Self-citationLewis, E. J., Hunsicker, L. G., Clarke, W. R., Berl, T., Pohl, M. A., Lewis, J. B., Ritz, E., Atkins, R. C., Rohde, R., & Raz, I. (2001) · New England Journal of Medicine · doi:10.1056/nejmoa011303 · Cited by 5,987
Self-citationStamler, J., Vaccaro, O., Neaton, J. D., Wentworth, D., & The Multiple Risk Factor Intervention Trial Research Group (1993) · Diabetes Care · doi:10.2337/diacare.16.2.434 · Cited by 4,063
Effect of a multifactorial intervention on mortality in type 2 diabetes
Gæde, P., Lund-Andersen, H., Parving, H.-H., & Pedersen, O. (2008) · New England Journal of Medicine · doi:10.1056/nejmoa0706245 · Cited by 3,465
Self-citationCorrection of anemia with epoetin alfa in chronic kidney disease
Singh, A. K., Szczech, L., Tang, K. L., Barnhart, H., Sapp, S., Wolfson, M., & Reddan, D. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa065485 · Cited by 2,762
Self-citationNormalization of Hemoglobin Level in Patients with Chronic Kidney Disease and Anemia
Drüeke, T. B., Locatelli, F., Clyne, N., Eckardt, K., Macdougall, I. C., Tsakiris, D., Burger, H.-U., & Scherhag, A. W. (2006) · New England Journal of Medicine · doi:10.1056/nejmoa062276 · Cited by 2,094
Self-citationEschbach, J. W., Abdulhadi, M. H., Browne, J. K., Delano, B. G., Downing, M. R., Egrie, J. C., Evans, R. W., Friedman, E. A., Graber, S. E., Haley, N. R., et al. (1989) · Annals of Internal Medicine · doi:10.7326/0003-4819-111-12-992 · Cited by 795
Blood Pressure Lowering Treatment Trialists’ Collaboration (2005) · Archives of Internal Medicine · doi:10.1001/archinte.165.12.1410 · Cited by 789
Booth, G. L., Kapral, M. K., Fung, K., & Tu, J. V. (2006) · The Lancet · doi:10.1016/s0140-6736(06)68967-8 · Cited by 782
The impact of anemia on cardiomyopathy, morbidity, and mortality in end-stage renal disease
Foley, R. N., Parfrey, P. S., Harnett, J. D., Kent, G. M., Murray, D. C., & Barré, P. E. (1996) · American Journal of Kidney Diseases · doi:10.1016/s0272-6386(96)90130-4 · Cited by 766
Self-citationLeyland-Jones, B. R., Семиглазов, В. Ф., Pawlicki, M., Pieńkowski, T., Tjulandin, S., Manikhas, G. M., Makhson, A., Roth, A., Dodwell, D. J., Baselga, J. M., et al. (2005) · Journal of Clinical Oncology · doi:10.1200/jco.2005.06.150 · Cited by 661
Phrommintikul, A., Haas, S. J., Elsik, M., & Krum, H. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60194-9 · Cited by 628
Recombinant Human Erythropoietin in the Treatment of Acute Ischemic Stroke
Ehrenreich, H., Weissenborn, K., Prange, H., Schneider, D., Weimar, C., Wartenberg, K., Schellinger, P. D., Bohn, M., Becker, H., Wegrzyn, M., et al. (2009) · Stroke · doi:10.1161/strokeaha.109.564872 · Cited by 605
Bohlius, J., Schmidlin, K., Brillant, C., Schwarzer, G., Trelle, S., Seidenfeld, J., Zwahlen, M., Clarke, M. J., Weingart, O., Kluge, S., et al. (2009) · The Lancet · doi:10.1016/s0140-6736(09)60502-x · Cited by 598
Keane, W. F., Brenner, B. M., de Zeeuw, D., Grunfeld, J.-P., McGill, J., Mitch, W. E., Ribeiro, A. B., Shahinfar, S., Simpson, R. L., Snapinn, S. M., et al. (2003) · Kidney International · doi:10.1046/j.1523-1755.2003.00885.x · Cited by 539
Self-citationLocatelli, F., Pisoni, R. L., Combe, C., Bommer, J., Andreucci, V. E., Piera, L., Greenwood, R. N., Feldman, H. I., Port, F. K., & Held, P. J. (2003) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfg458 · Cited by 465
Parfrey, P., Foley, R., Wittreich, B. H., Sullivan, D. J., Zagari, M., & Frei, D. (2005) · Journal of the American Society of Nephrology · doi:10.1681/asn.2004121039 · Cited by 399
Self-citationAnemia as a Risk Factor for Cardiovascular Disease and All-Cause Mortality in Diabetes
Vlagopoulos, P. T., Tighiouart, H., Weiner, D. E., Griffith, J. L., Pettitt, D., Salem, D. N., Levey, A. S., & Sarnak, M. J. (2005) · Journal of the American Society of Nephrology · doi:10.1681/asn.2005030226 · Cited by 314
Self-citationEffect of Pravastatin on Rate of Kidney Function Loss in People With or at Risk for Coronary Disease
Tonelli, M. A., Isles, C., Craven, T. E., Tonkin, A., Pfeffer, M. A., Shepherd, J., Sacks, F. M., Furberg, C. D., Cobbe, S. M., Simes, J. R., et al. (2005) · Circulation · doi:10.1161/circulationaha.104.517565 · Cited by 190
Self-citationThe agonising negative trend in monitoring of clinical trials
DeMets, D. L., Pocock, S. J., & Julian, D. G. (1999) · The Lancet · doi:10.1016/s0140-6736(99)03464-9 · Cited by 126
Principles From Clinical Trials Relevant to Clinical Practice: Part I
Califf, R. M., & DeMets, D. L. (2002) · Circulation · doi:10.1161/01.cir.0000023260.78078.bb · Cited by 108
Haemoglobin and haematocrit targets for the anaemia of chronic kidney disease
Strippoli, G. F., Navaneethan, S. D., Craig, J. C., & Palmer, S. C. (2006) · Cochrane Database of Systematic Reviews · doi:10.1002/14651858.cd003967.pub2 · Cited by 106
Mozzicato, P. (2007) · Drug Safety · doi:10.2165/00002018-200730070-00009 · Cited by 96
Haemoglobin targets: we were wrong, time to move on
Strippoli, G. F., Tognoni, G., Navaneethan, S. D., Nicolucci, A., & Craig, J. C. (2007) · The Lancet · doi:10.1016/s0140-6736(07)60165-2 · Cited by 95
Tong, P. C. Y., Kong, A. P. S., So, W., Ng, M. H. L., Yang, X., Ng, M. C. Y., Ronald, C. W., Ho, C. S., Lam, C. W. K., Chow, C., et al. (2006) · Diabetes Care · doi:10.2337/dc06-0887 · Cited by 71
Baseline Characteristics in the Trial to Reduce Cardiovascular Events With Aranesp Therapy (TREAT)
Pfeffer, M. A., Burdmann, E. A., Chen, C.-Y., Cooper, M. E., de Zeeuw, D., Eckardt, K., Ivanovich, P. T., Kewalramani, R., Levey, A. S., Lewis, E. F., et al. (2009) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2009.04.008 · Cited by 65
Self-citationAn Ongoing Study of Anemia Correction in Chronic Kidney Disease
Pfeffer, M. A. (2007) · New England Journal of Medicine · doi:10.1056/nejmc066568 · Cited by 36
Self-citationLocatelli, F., Pisoni, R. L., Combe, C., Bommer, J., Andreucci, V. E., Piera, L., Greenwood, R. N., Feldman, H. I., FK, F. K. P., & Held, P. J. (2004) · Nephrology Dialysis Transplantation · doi:10.1093/ndt/gfh314 · Cited by 18
Critical Missing Data on Erythropoiesis-Stimulating Agents in CKD: First Beat Placebo
Pfeffer, M. A. (2008) · American Journal of Kidney Diseases · doi:10.1053/j.ajkd.2008.01.003 · Cited by 15
Self-citationUncertainty in the treatment of anemia in chronic kidney disease.
Pfeffer, M. A., Solomon, S. D., Singh, A. K., Ivanovich, P. T., & McMurray, J. J. V. (2005) · PubMed · Cited by 9
Self-citation
Flagged first, then by citations
Research works printed but not linked: 2
- Pfeffer MA, 2005, Rev Cardiovasc Med, 3, S35
- Strippoli GF, 2006, Cochrane Database Syst Rev, 4, CD003967
Cited by
Sorted by citations
Targeting Hypoxia-Inducible Factors for the Treatment of Anemia in Chronic Kidney Disease Patients
Locatelli, F., Fishbane, S. N., Block, G. A., & Macdougall, I. C. (2017) · American Journal of Nephrology · doi:10.1159/000455166 · Cited by 4,836
Cosentino, F., Grant, P. J., Aboyans, V., Bailey, C. J., Ceriello, A., Delgado, V., Federici, M., Filippatos, G., Grobbee, D. E., Hansen, T. B., et al. (2020) · European Heart Journal · doi:10.1093/eurheartj/ehz486 · Cited by 4,763
Weiss, G., & Goodnough, L. T. (2005) · New England Journal of Medicine · doi:10.1056/nejmra041809 · Cited by 3,800
2017 ACC/AHA/HFSA Focused Update of the 2013 ACCF/AHA Guideline for the Management of Heart Failure
Yancy, C. W., Jessup, M. L., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., Drazner, M. H., Filippatos, G. S., Fonarow, G. C., Givertz, M. M., et al. (2017) · Journal of the American College of Cardiology · doi:10.1016/j.jacc.2017.04.025 · Cited by 3,507
Yancy, C. W., Jessup, M., Bozkurt, B., Butler, J., Casey, D. E., Colvin, M. M., Drazner, M. H., Filippatos, G. S., Fonarow, G. C., Givertz, M. M., et al. (2017) · Circulation · doi:10.1161/cir.0000000000000509 · Cited by 3,109
Metadata
- Authors
- Pfeffer, M. A., Burdmann, E. A., Chen, C.-Y., Cooper, M. E., de Zeeuw, D., Eckardt, K.-U., Feyzi, J. M., Ivanovich, P., Kewalramani, R., Levey, A. S., Lewis, E. F., McGill, J. B., McMurray, J. J. V., Parfrey, P., Parving, H.-H., Remuzzi, G., Singh, A. K., Solomon, S. D., & Toto, R.
- Affiliations
- Brigham and Women's Hospital (US)
- Hospital de Base (BR)
- Friedrich-Alexander-Universität Erlangen-Nürnberg (DE)
- University of Wisconsin–Madison (US)
- Northwestern University (US)
- Tufts University (US)
- Harvard University (US)
- Washington University in St. Louis (US)
- University of Glasgow (GB)
- University of Copenhagen (DK)
- The University of Texas Southwestern Medical Center (US)
- ORCID
- Venue
- New England Journal of Medicine
- Publisher
- Massachusetts Medical Society
- Published
- 2009-11-19
- Volume
- 361
- Issue
- 21
- Pages
- 2019-2032
- ISSN
- 0028-4793 (ISSN-L)
- 1533-4406
- OpenAlex
- W1998943227
- Cited by
- 2,096
- References
- 32
- Citations by year
- 2026: 62 · 2025: 66 · 2024: 65 · 2023: 94 · 2022: 92 · 2021: 128 · 2020: 121 · 2019: 111 · 2018: 90 · 2017: 108 · 2016: 125 · 2015: 122 · 2014: 163 · 2013: 174 · 2012: 175
- FWCI
- 125.33
- Type
- journal article
- Language
- en
- Open access
- bronze
- doi.org
- Locations
- New England Journal of Medicine (publishedVersion)
- PubMed (publishedVersion)
- Research at the University of Copenhagen (University of Copenhagen) (publishedVersion)
- Archivio Istituzionale della Ricerca - Università degli Studi della Campania "Luigi Vanvitelli" (submittedVersion)
- University of Groningen research database (University of Groningen / Centre for Information Technology) (submittedVersion)
- Funders
- Robert Wood Johnson Foundation
- Amgen
- Bristol-Myers Squibb
- Pfizer
- AstraZeneca
- GlaxoSmithKline
- Sanofi
- Biogen
- Louisiana Board of Regents
- Boston Scientific Corporation
- McGill University
- Celladon Corporation
- Covis Pharma
- Cytokinetics
- Servier
- Genentech
- Daiichi Sankyo Europe
- Topics
- Health Sciences › Medicine › Hematology › Erythropoietin and Anemia Treatment
- Health Sciences › Medicine › Nephrology › Dialysis and Renal Disease Management
- Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
- Keywords
- darbepoetin alfa, type 2 diabetes, chronic kidney disease, anemia, erythropoiesis-stimulating agents, cardiovascular events, end-stage renal disease, stroke, red blood cell transfusion, fatigue, hemoglobin target, cardiovascular risk reduction, non-dialysis patients
- MeSH terms
- Darbepoetin alfa, Aged, Anemia, Cardiovascular Diseases, Diabetes Mellitus, Type 2, Double-Blind Method, Erythropoietin, Female, Hematinics, Hemoglobins, Humans, Kidney Failure, Chronic, Male, Middle Aged, Neoplasms, Stroke, Renal Insufficiency, Chronic, Kaplan-Meier Estimate
About these checks
Registry, retraction, Cites and statistics results are computed, not judged, with one exception: a printed reference that no index lists is read once by a model before it counts as a citation error. Claims are extracted by a model and kept only when their quote appears verbatim in the text; each cited source is then checked, with a model’s help, for whether it says what the claim relies on. Those verdicts can be wrong — read the claim’s quote and the cited source before relying on one.
Statistics and arithmetic are recomputed, not judged.
Confidence bands are shown only for fields calibrated on our annotated test set. None is calibrated yet, so no band is shown.
What counts as a claim ›How we measure confidence ›How we check this ›
Are you an author, or do you see a problem with this page? Request a review
