{"doi":"10.1016/j.ekir.2020.10.010","title":"Phase-3 Randomized Controlled Trials on Exclusion of Participants With Kidney Disease in COVID-19","abstract":"Severe acute respiratory syndrome coronavirus 2, the virus that causes coronavirus disease 2019 (COVID-19), has a range of presentations and outcomes from asymptomatic carriage to acute respiratory distress syndrome and death.1Harapan H. Itoh N. Yufika A. et al.Coronavirus disease 2019 (COVID-19): A literature review.J Infect Public Health. 2020; 13: 667-673Crossref PubMed Scopus (971) Google Scholar The incidence of acute kidney injury (AKI) is high among patients with COVID-19.2Hirsch J.S. Ng J.H. Ross D.W. et al.Acute kidney injury in patients hospitalized with COVID-19.Kidney Int. 2020; 98: 209-218Abstract Full Text Full Text PDF PubMed Scopus (1020) Google Scholar,3Batlle D. Soler M.J. Sparks M.A. et al.Acute kidney injury in COVID-19: emerging evidence of a distinct pathophysiology.J Am Soc Nephrol. 2020; 31: 1380-1383Crossref PubMed Scopus (413) Google Scholar Moreover, patients with chronic kidney disease (CKD), who make up more than 10% of the global population,4Coresh J. Update on the burden of CKD.J Am Soc Nephrol. 2017; 28: 1020Crossref PubMed Scopus (122) Google Scholar are at high risk for severe COVID-19.5Henry B.M. Lippi G. Chronic kidney disease is associated with severe coronavirus disease 2019 (COVID-19) infection.Int Urol Nephrol. 2020; 52: 1193-1194Crossref PubMed Scopus (399) Google Scholar Patients with end-stage renal disease who make frequent visits to in-center hemodialysis facilities are at high risk for exposure to and infection with severe acute respiratory syndrome coronavirus 2 and are at high risk of developing disease once exposed because of their older average age and multiple comorbidities.6Ikizler T.A. COVID-19 and dialysis units: what do we know now and what should we do?.Am J Kidney Dis. 2020; 76: 1-3Abstract Full Text Full Text PDF PubMed Scopus (890) Google Scholar Remarkably, nearly 250 phase-3 randomized controlled trials have been planned to identify safe and effective interventions to prevent or treat COVID-19. To inform practitioners and researchers whether and how findings from these trials can be applied to patients with kidney disease (AKI, CKD, or end-stage renal disease), we conducted a systematic review of registered trials and quantified the proportion of potential subjects with kidney disease who are excluded from enrollment. Variables predicting trials with exclusion criteria regarding kidney disease were also explored using multiple logistic regression (Supplementary Methods). A total of 248 trials were identified, of which 55 trials did not meet the inclusion criteria (13 trials were for unrelated topics, 4 trials were nonrandomized single-arm interventions, and 38 trials included fewer than 100 participants). Of the remaining 193 trials (representing 258,794 participants), 83 trials (43.0%) (representing 149,294 participants [57.7%]) excluded patients with kidney disease. Criteria to exclude patients with kidney disease included abnormal estimated glomerular filtration rate (eGFR) or renal replacement therapy (n = 57 trials), abnormal serum creatinine (n = 6 trials), history of kidney stone (n = 1 trial), history of nephrotic syndrome (n = 1 trial), or renal impairment, not further specified (n = 18 trials). The eGFR thresholds provided as exclusion cutoffs are summarized in Figure 1. The exclusion of patients with kidney disease occurred across the spectra of trials with varying sample sizes, funding sources, and outpatient/inpatient settings (Table 1). Details on the exclusion criteria thresholds applied to each trial for each intervention are shown in Table 2. The corresponding appropriate thresholds at which each intervention was contraindicated are represented in Supplementary Table S1. It appears that exclusion criteria regarding kidney disease are generally applied regardless of number of enrollments (100–499, 500–999, >1,000), participant settings (outpatient, inpatient, health care workers, and not specified), locations (North America, South America, Africa, Asi","journal":"Kidney International Reports","year":2020,"id":84735,"datarank":0.0,"base_score":0.0,"endowment":0.0,"self_citation_contribution":0.0,"citation_network_contribution":0.0,"self_endowment_contribution":0.0,"citer_contribution":0.0,"corpus_percentile":null,"corpus_rank":null,"citation_count":9,"citer_count":0,"citers_with_citation_signal":0,"citers_with_endowment":0,"datacite_reuse_total":0,"is_dataset":false,"is_dataset_confidence":0.9631,"is_data_producer":false,"deposit_databanks":null,"is_oa":true,"file_count":0,"downloads":0,"has_version_chain":false,"published_date":"2020-01-01","fair_score":null,"fair_percentile":null,"algorithm_id":"datarank_citation_only_1hop_v6","ranking_scope":"data_only","authors":[{"id":434243,"name":"Yuan‐Ting Chang","orcid":"0000-0002-5716-8803","position":1,"is_corresponding":false},{"id":263649,"name":"Meghan E. Sise","orcid":"0000-0002-4327-9713","position":2,"is_corresponding":false},{"id":35850,"name":"Roby P. Bhattacharyya","orcid":"0000-0001-6955-5088","position":3,"is_corresponding":false},{"id":231936,"name":"Megan Murray","orcid":"0000-0003-0443-1986","position":4,"is_corresponding":false},{"id":434244,"name":"Sagar U. Nigwekar","orcid":"0000-0002-6750-0072","position":5,"is_corresponding":false},{"id":434242,"name":"Api Chewcharat","orcid":"0000-0002-1707-9988","position":0,"is_corresponding":true}],"reference_count":7,"raw_metadata":null,"created_at":"2026-07-18T21:55:38.506333Z","pmid":"33106779","pmcid":null,"fwci":null,"citation_percentile":null,"influential_citations":0,"oa_status":null,"license":null,"views":0,"total_file_size_bytes":0,"version_count":0,"fair_f":null,"fair_a":null,"fair_i":null,"fair_r":null,"fair_zscore":null,"fair_rationale":null,"fair_model":null,"fair_agent_version":null,"fair_fulltext_source":null,"fair_has_llm":null,"fair_computed_at":null,"clinical_trials":[],"software_tools":[],"db_accessions":[],"linked_datasets":[],"topics":[]}