ArticleClinical and translational science2021
Design and conduct considerations for studies in patients with impaired renal function.
Article in Clinical and translational science, 2021. The graph could read no effect estimate from its abstract, so it casts no vote on the map. Cited by 13 papers, 1 of them a synthesis that pooled it.
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Trials whose registry record cites this paper, or whose number appears in the abstract. A trial that started after this paper was published is citing it as background, not reporting it.
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Who cites it
13 citing papers in PubMed, 1 synthesis or guideline pooled it, 25 citations in OpenAlex.
- Re-discover the value of protein binding assessments in hepatic and renal impairment studies and its contributions in drug labels and dose decisions.Clinical and translational science · 2024Pooled it
- Effects of renal impairment and hemodialysis on the pharmacokinetics and safety of HRS-8427, a siderophore cephalosporin for Gram-negative bacterial infections.Antimicrobial agents and chemotherapy · 2026Article
- A short review of dose-finding adaptive trial designs for clinical pharmacologists and non-statisticians in oncology.European journal of clinical pharmacology · 2026Review
- Evaluation of Adefovir PBPK Model to Assess Biomarker-Informed OAT1 Drug-Drug Interaction and Effect of Chronic Kidney Disease.CPT: pharmacometrics & systems pharmacology · 2025Article
- Operating Characteristics of the Simulated Healthy Participant Approach in Impaired Clearance Studies.The AAPS journal · 2025Article
- Development and validation of a deep learning algorithm for the prediction of serum creatinine in critically ill patients.JAMIA open · 2024Article
- Simulating Healthy Participant Pharmacokinetics for Renal and Hepatic Impairment Studies: Retrospective Assessment of the Approach.The AAPS journal · 2024Article
- Efficacy and safety of prucalopride in patients with chronic idiopathic constipation stratified by age, body mass index, and renal function: a post hoc analysis of phase III and IV, randomized, placebo-controlled clinical studies.Therapeutic advances in gastroenterology · 2024Article
- Anticoagulation in Patients with Chronic Kidney Disease.American journal of nephrology · 2024Review
- Physiologically Based Pharmacokinetic Modelling to Predict Imatinib Exposures in Cancer Patients with Renal Dysfunction: A Case Study.Pharmaceutics · 2023Article
- Design and conduct considerations for studies in patients with hepatic impairment.Clinical and translational science · 2023Review
- Estimation of glomerular filtration rate for drug dosing in patients with very high or low body mass index.Clinical and translational science · 2022Article
- Translation of Pharmacodynamic Biomarkers of Antibiotic Efficacy in Specific Populations to Optimize Doses.Antibiotics (Basel, Switzerland) · 2021Review
Corrections and comments
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Authors and funding
3 authors at 2 institutions in 2 countries.
Funding
No grant is acknowledged in the PubMed record.
Abstract
An impaired renal function, including acute and chronic kidney disease and end-stage renal disease, can be the result of aging, certain disease conditions, the use of some medications, or as a result of smoking. In patients with renal impairment (RI), the pharmacokinetics (PKs) of drugs or drug metabolites may change and result in increased safety risks or decreased efficacy. In order to make specific dose recommendations in the label of drugs for patients with RI, a clinical trial may have to be conducted or, when not feasible, modeling and simulations approaches, such as population PK modeling or physiologically-based PK modelling may be applied. This tutorial aims to provide an overview of the global regulatory landscape and a practical guidance for successfully designing and conducting clinical RI trials or, alternatively, on applying modeling and simulation tools to come to a dose recommendation for patients with RI in the most efficient manner.
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Registered trials
Read under generation 80e0d062 · epoch 390. Bibliography from PubMed, PubMed Central and OpenAlex; grants from NIH RePORTER; trial links from ClinicalTrials.gov; estimates, votes and beliefs from the OpenQuestion graph.