Specialised Renal and Hepatic Impairment Trials
With over 30 years of expertise, CRS Kiel is a recognised global leader in early-phase clinical research involving patients with renal and hepatic impairments. We are dedicated to advancing therapies for kidney and liver diseases, including complex conditions where organ impairments impact standard of care.
Our team specializes in the high-precision management of complex trial designs, including studies involving dose titration, diverse drug formulations and delivery methods, as well as food- and drug-interaction assessments. This expertise ensures accurate, reliable results even in challenging pharmacological contexts.
Located adjacent to Kiel University Hospital, CRS Kiel offers a warm, patient-friendly environment tailored to the needs of clinical trial participants.
The unit focuses primarily on small to mid-sized studies and complex pharmacokinetic (PK) and pharmacodynamic (PD) evaluations in patients with varying degrees of renal and hepatic impairment, as well as elderly populations.
Below are examples of the renal and hepatic assessments on offer, combining both standard and specialised methods tailored to each patient’s needs:
Hepatic
Renal
CRS Kiel is equipped with advanced telemetric systems for continuous participant monitoring, with one to two participants typically hospitalised per room to ensure individualised medical attention. The unit includes dedicated spaces for medical examinations and an in-house pharmacy managed by a licensed pharmacist for the secure storage and dispensation of investigational medications.
Our facility maintains a long-standing partnership with the accredited medical laboratory LKF (Laboratorium für Klinische Forschung GmbH), enabling rapid turnaround of lab results. Combined with our in-house blood and urine processing capabilities, this integrated setup ensures efficient screening and real-time safety monitoring across all studies.
CRS Kiel also benefits from direct access to a broad clinical network, including leading hepatologists, nephrologists, outpatient clinics, dialysis centers, and other specialist departments at the University Hospital Schleswig-Holstein (UKSH). This close collaboration with expert partners supports alignment with current standards of care and facilitates the rapid identification and recruitment of qualified participants—including elderly control subjects—ensuring timely study start-up and execution.
CRS Kiel stands at the forefront of clinical trials for patients with renal and hepatic impairments under the leadership of Dr. Maria Lehretz, Medical Director. The staff’s extensive experience with this patient population is continuously enhanced through training, ensuring comprehensive knowledge of potential risks and effective management strategies.
Our experienced team of scientists, investigators, project managers, data managers, biostatistics and PK consultants, medical writers, and more can guide you through all stages of your clinical trial, from study design and protocol development through to results interpretation and reporting.
Reach out today to find out how we can help achieve your clinical trial objectives with our patient-centered approach and wealth of expertise in hepatology, nephrology, and clinical development.
