Cited by 271Chronic Kidney Disease and DiabetesStatistical Methods in Clinical TrialsEthics in Clinical Research

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The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease

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Charytan, D., Kuntz, R.E.·2006·Kidney International

DOI 10.1038/sj.ki.5001934PMC PMC2950017

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Abstract

Chronic kidney disease (CKD) is associated with a high risk of death from coronary artery disease and may modify the response to standard cardiovascular therapies. Treatment of subjects with CKD should ideally be based on evidence from randomized, clinical trials, but how often subjects with CKD have been excluded from these trials is uncertain. We undertook this study in order to quantify how often subjects with moderate to advanced CKD were excluded from large cardiovascular trials. MEDLINE and the reference list of selected articles were searched in order to identify large, randomized, controlled trials of five different coronary artery disease therapies published between 1998 and 2005. Exclusion criteria and reported clinical characteristics of subjects were abstracted. Rates of exclusion and reporting of baseline characteristics of study participants were compared for CKD, diabetes, history of smoking, and hypertension. Eighty-six trials randomizing 411 653 patients were identified. More than 80% of trials excluded subjects with end-stage renal disease and 75.0% excluded patients with CKD. Subjects with diabetes, hypertension, or a history of smoking were excluded less than 4% of the time. Baseline renal function of study participant was reported in only 7% of trials. Patients with CKD are frequently excluded from coronary artery disease trials and renal function of randomized subjects is rarely reported. These findings reinforce the notion that available data on the tre…

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Authors: Charytan, D., & Kuntz, R. E.
Affiliations: Brigham and Women's Hospital (US)
Medtronic (United States) (US)
Corresponding author: Charytan, D.
ORCID: Charytan, D.
Venue: Kidney International
Publisher: Elsevier BV
Published: 2006-12
Volume: 70
Issue: 11
Pages: 2021-2030
ISSN: 0085-2538 (ISSN-L)
DOI: 10.1038/sj.ki.5001934
PMC: PMC2950017
OpenAlex: W2030060276
Cited by: 271
References: 117
Citations by year: 2026: 7 · 2025: 10 · 2024: 24 · 2023: 19 · 2022: 17 · 2021: 24 · 2020: 24 · 2019: 13 · 2018: 17 · 2017: 18 · 2016: 11 · 2015: 9 · 2014: 14 · 2013: 10 · 2012: 11
FWCI: 5.59
Type: journal article
Language: en
Open access: bronze
doi.org
Licence: www.elsevier.com/tdm/userlicense/1.0/ (tdm)
www.elsevier.com/open-access/userlicense/1.0/ (vor, 3293 d)
Locations: Kidney International (publishedVersion)
PubMed (publishedVersion)
PubMed Central (acceptedVersion)
Funders: National Institutes of Health (T32 DK007527-22)
Topics: Health Sciences › Medicine › Nephrology › Chronic Kidney Disease and Diabetes
Physical Sciences › Mathematics › Statistics and Probability › Statistical Methods in Clinical Trials
Health Sciences › Medicine › Public Health, Environmental and Occupational Health › Ethics in Clinical Research
Keywords: chronic kidney disease, coronary artery disease, exclusion criteria, inclusion and exclusion criteria, end-stage renal disease, diabetes mellitus, hypertension, smoking history, cardiovascular disease treatment, generalizability of trial results
MeSH terms: Adrenergic beta-Antagonists, Clinical Trials as Topic, Coronary Artery Disease, Humans, Platelet Aggregation Inhibitors, Patient Selection, Platelet Glycoprotein GPIIb-IIIa Complex, Hydroxymethylglutaryl-CoA Reductase Inhibitors, Renal Insufficiency, Chronic

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The exclusion of patients with chronic kidney disease from clinical trials in coronary artery disease

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