Abstract
Acute kidney injury is associated with significant morbidity and mortality in hospitalized patients. Clinical trials for acute kidney injury have been hampered not only by a paucity of appropriate potential therapeutic agents, but also by several clinical trial design challenges. First, for novel therapies to have the best chance at efficacy, early patient identification is critical. Second, for certain novel therapies with a mechanism of action directed at the underlying disease state (e.g., sepsis) or a specific pathogenic process, careful disease phenotyping may be required. Third, even among patients with AKI, risk stratification may be required to select a higher-risk subset for clinical trials. Finally, clinical endpoints for clinical trials must be considered carefully, as patients may die for reasons unrelated to AKI, including withdrawal of support. However, these challenges are not unique to AKI; some possible solutions including alternative endpoints used in other clinical trial settings are reviewed here.
Keywords: Acute kidney injury, acute tubular necrosis, clinical trial design, surrogate endpoint, biomarker
Current Drug Targets
Title: Clinical Trials for Acute Kidney Injury: Design Challenges and Possible Solutions
Volume: 10 Issue: 12
Author(s): Kathleen D. Liu and David V. Glidden
Affiliation:
Keywords: Acute kidney injury, acute tubular necrosis, clinical trial design, surrogate endpoint, biomarker
Abstract: Acute kidney injury is associated with significant morbidity and mortality in hospitalized patients. Clinical trials for acute kidney injury have been hampered not only by a paucity of appropriate potential therapeutic agents, but also by several clinical trial design challenges. First, for novel therapies to have the best chance at efficacy, early patient identification is critical. Second, for certain novel therapies with a mechanism of action directed at the underlying disease state (e.g., sepsis) or a specific pathogenic process, careful disease phenotyping may be required. Third, even among patients with AKI, risk stratification may be required to select a higher-risk subset for clinical trials. Finally, clinical endpoints for clinical trials must be considered carefully, as patients may die for reasons unrelated to AKI, including withdrawal of support. However, these challenges are not unique to AKI; some possible solutions including alternative endpoints used in other clinical trial settings are reviewed here.
Export Options
About this article
Cite this article as:
Liu D. Kathleen and Glidden V. David, Clinical Trials for Acute Kidney Injury: Design Challenges and Possible Solutions, Current Drug Targets 2009; 10 (12) . https://dx.doi.org/10.2174/138945009789753282
DOI https://dx.doi.org/10.2174/138945009789753282 |
Print ISSN 1389-4501 |
Publisher Name Bentham Science Publisher |
Online ISSN 1873-5592 |
Call for Papers in Thematic Issues
New drug therapy for eye diseases
Eyesight is one of the most critical senses, accounting for over 80% of our perceptions. Our quality of life might be significantly affected by eye disease, including glaucoma, diabetic retinopathy, dry eye, etc. Although the development of microinvasive ocular surgery reduces surgical complications and improves overall outcomes, medication therapy is ...read more
- Author Guidelines
- Graphical Abstracts
- Fabricating and Stating False Information
- Research Misconduct
- Post Publication Discussions and Corrections
- Publishing Ethics and Rectitude
- Increase Visibility of Your Article
- Archiving Policies
- Peer Review Workflow
- Order Your Article Before Print
- Promote Your Article
- Manuscript Transfer Facility
- Editorial Policies
- Allegations from Whistleblowers
Related Articles
-
Pharmacotherapeutic Potential of Garlic in Age-Related Neurological Disorders
CNS & Neurological Disorders - Drug Targets Emerging Treatment Strategies and Potential Therapeutic Targets in Primary Sjogrens Syndrome
Inflammation & Allergy - Drug Targets (Discontinued) Current Advances in Therapy for Metastatic Melanoma
Current Cancer Therapy Reviews New Physiological Targets Within the Kidney for Antihypertensive Therapy
Drug Design Reviews - Online (Discontinued) Diverse Thiophenes as Scaffolds in Anti-cancer Drug Development: A Concise Review
Mini-Reviews in Medicinal Chemistry A Systematic Review of Randomized Controlled Trials Examining the Nephroprotective Properties of Antihypertensive Medications
Current Hypertension Reviews Disentangling the Intricacies of Migraine: A Review
CNS & Neurological Disorders - Drug Targets The Effect of Sex and Gender on Diabetic Complications
Current Diabetes Reviews New Antipsychotics and Schizophrenia: A Review on Efficacy and Side Effects
Current Medicinal Chemistry Deletion of Endoplasmic Reticulum Stress-Induced CHOP Protects Microvasculature Post-Spinal Cord Injury
Current Neurovascular Research Safety of Nanoparticles in Medicine
Current Drug Targets Waste Material of Propolis as a Film Forming Agent Intended to Modify the Metronidazole Release: Preparation and Characterization
Current Drug Delivery Dopamine: The Forgotten Felon in Type 2 Diabetes
Recent Patents on Endocrine, Metabolic & Immune Drug Discovery Nitric Oxide, Peroxynitrite, Peroxynitrous Acid, Nitroxyl, Nitrogen Dioxide, Nitrous Oxide: Biochemical Mechanisms and Bioaction
Current Bioactive Compounds Modification Strategies of Lipid-Based Nanocarriers for Mucosal Drug Delivery
Current Pharmaceutical Design Bortezomib – First Therapeutic Proteasome Inhibitor for Cancer Therapy: A Review of Patent Literature
Recent Patents on Anti-Cancer Drug Discovery Effects of Flavonoids in Experimental Models of Arterial Hypertension
Current Topics in Medicinal Chemistry Stenting and Prevention of Ischemic Stroke
Current Drug Targets Therapeutic Angiogenesis in Ischemic Heart Disease: Gene or Recombinant Vascular Growth Factor Protein Therapy?
Current Gene Therapy CD20-based Immunotherapy of B-cell Derived Hematologic Malignancies
Current Cancer Drug Targets