Renal and Hepatic Impairment Clinical Trials
Clinical Pharmacology Expertise in Renal and Hepatic Impairment Clinical Studies
Renal and hepatic impairment studies have critical implications for patient safety and therapeutic efficacy, and the data informs appropriate dosing regimens. Regulatory authorities generally require at least one of these studies, depending on the elimination pathway of your drug.
Ready to Conduct a Renal and/or Hepatic Impairment Trial? Here's Why You Should Conduct It with Us
We leverage our three clinical pharmacology units and expansive site network, to efficiently access the specific impairment (mild, moderate, or severe) and matched healthy populations you need.
We have completed 100+ studies using multiple routes of administration, including parenteral injections. We offer a comprehensive turnkey solution that includes full and two-stage adaptive integrated designs in accordance with FDA and EMA guidance, project and site management, bioanalytical support, data management, biostatistics, regulatory support, and report writing.
Ready to safely accelerate your renal and hepatic clinical trials? Speak with our experts today and discover how we can help bring your drug development program to life.
Rapid and Efficient Renal and Hepatic Impairment Clinical Study Start-Up
Altasciences streamlines contract execution, regulatory document preparation, and participant recruitment to ensure efficiency and timely results. With strong project management, a dedicated internal team, and close collaboration with sites and sponsors, we can significantly reduce start-up timelines.
With three clinical pharmacology units and co-located bioanalytical laboratories, as well as a trusted network of external sites in the U.S. and Canada, we provide dual regulatory pathway options—Investigational New Drug (IND) and Clinical Trial Application (CTA).
Recruitment for Renal/Hepatic
Clinical Trials
Effective recruitment and retention are critical to your renal/hepatic clinical trial’s success. We create a project-specific recruitment plan that is customized to define the specific recruitment strategy and enrollment thresholds to allow for swift and efficient enrollment.
We employ comprehensive site selection and screening methods to develop a robust list of locations with access to renal and hepatic impaired clinical trial participants, allowing us to identify specific subpopulations of patients with renal or hepatic impairment and accurately determine the severity of their condition, along with other relevant medical history.
With a large in-house database of over 400,000 healthy normal volunteers, special populations and patients , combined with the reach of our extensive specialty site network, we can rapidly recruit and enroll participants.
We excel in the rapid enrollment of renal and hepatic impairment clinical studies, leveraging our extensive database and network along with proven recruitment strategies. For example, it took us three months to complete the enrollment of eight patients per group of severe, moderate, and mild renal impairment patients, and healthy matches. Our efficient process is driven by targeted outreach, strong relationships with local dialysis centers, and access to a comprehensive pool of renal impairment patients and healthy volunteers, ensuring timely and reliable study initiation.
Key Advantages of Our Recruitment Strategy
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Fast enrollment of renal and hepatic impaired patients and healthy populations. |
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Access to patients with mild, moderate, and severe renal impairment through our primary database or by leveraging our network of partner sites. |
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Close collaboration with dialysis centers or other specialized investigators for studies involving patients with end-stage renal disease (ESRD). |
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Access to patients with mild, moderate, and severe hepatic impairment, whether due to alcohol abuse or other causes, in every category: with NASH, Child-Pugh A, Child-Pugh B, and Child-Pugh C. |
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Access to matching healthy control subjects through a database of over 120,000 participants; 40,000 of which are active. |
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Tailored inclusion and exclusion criteria to optimize patient safety and recruitment while maintaining a diverse and representative study population. |
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Precision dosing pharmacokinetic assessments to determine dosage adjustments for patients with impaired renal or hepatic function. |
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Defined enrollment thresholds and milestones to ensure ongoing recruitment goals are achieved and strategies are implemented. |
Turnkey Solution for Renal and Hepatic Impairment Clinical Studies
Conducting clinical studies in renal and hepatic impairment requires specialized knowledge and a tailored approach. our highly experienced and dedicated early-phase team understands the intricacies of renal and hepatic impaired patient populations, ensuring effective trial design, conduct, and patient engagement, delivering end-to-end clinical trial services for your NDA-enabling clinical pharmacology trials.
Our project management team expertly leads your renal and hepatic impairment study from award through closeout and is committed to delivering high-quality results that drive informed decision-making for your drug development programs. Our ability to provide data at key milestones, such as prior to Phase III initiation, for NDA filing or as a post-marketing commitment is the cornerstone of Altasciences delivery.
With a proven track record of over 100 successful studies, we offer a comprehensive turnkey solution that includes protocol design, project and site management, bioanalytical support, data management, biostatistics, regulatory support, and report writing.
Related Resources for Renal/Hepatic Clinical Trials
Fact Sheets
Webpages
FAQS
What are renal and hepatic impairment clinical studies?
Renal and hepatic impairment trials are clinical studies designed to assess how drugs behave in patients with impaired kidney (renal) or liver (hepatic) function. These trials help determine whether dosage adjustments or additional safety precautions are needed for these populations.
Renal impairment trials study how a drug is processed (pharmacokinetics) in patients with reduced kidney function, and hepatic impairment trials study drug metabolism in patients with liver dysfunction.
What are the parameters studied in renal and hepatic impairment clinical trials?
Common parameters for renal impairment studies:
- Creatinine clearance (CrCl) or estimated glomerular filtration rate (eGFR)
- Drug half-life and plasma concentration
Common parameters for hepatic impairment studies:
- Liver function tests (ALT, AST, bilirubin, albumin)
- Pharmacokinetic changes in drug metabolism
How are renal impairment patients categorized for clinical trials?
The categorization of impairment for these studies is mild, moderate, severe, or end-stage kidney disease. Since the kidneys are responsible for eliminating many drugs and their metabolites, impaired renal function can lead to drug accumulation and toxicity, and it is important to study the impact in different levels of impairment.
What are the objectives of renal and hepatic impairment studies?
Both renal and hepatic impairment studies provide data that inform appropriate dosing recommendations and adjustments.
Renal impairment objectives
- Assess drug clearance in patients with varying degrees of renal impairment (mild, moderate, severe, or end-stage kidney disease).
- Evaluate the risk of drug accumulation and adverse effects.
Hepatic impairment objectives
- Assess how liver impairment affects drug metabolism and clearance.
- Identify potential safety concerns or toxicities.
- Determine dosing recommendations.