Targeted Therapeutic Area

Renal and Hepatic Impairment Trials

CRS Clinical Research Services, part of hVIVO, is committed to advancing therapies for kidney and liver diseases, including complex conditions where organ impairments impact standard care. Below are examples of the renal and hepatic assessments on offer, combining both standard and specialised methods tailored to each patient’s needs.

Hepatic

Sonography

Fibroscan

Fibrotest

Magnetic resonance imaging (MRI) and computerised tomography (CT) imaging

Child-Pugh classification

MELD (end-stage liver disease) score

Number connection test

Comprehensive liver function tests

Specialised liver laboratory parameters and tests

Renal

Estimated glomerular filtration rate (eGFR)

Renal plasma flow rate

Urinary output and electrolyte/creatinine excretion

Body surface area (BSA) adaptations using Mosteller or DuBois formulas

Cystatin C (CysC)

Osmolarity

Iohexol

Pharmacokinetic assessments during dialysis

Dedicated to advancing therapies in renal and hepatic disease

Since the early 1990s, CRS has been a recognised leader in early-phase clinical trials for patients with renal and hepatic impairments, as well as elderly populations. Based in Germany, CRS operates specialised clinical sites that prioritise participant safety and well-being through close collaboration with local nephrologists, hepatologists, and partner clinics. The team has extensive experience designing and conducting complex pharmacokinetic (PK) and pharmacodynamic (PD) trials, managing intricate protocols involving dose titrations, multiple drug formulations, varied administration routes, and food-drug interactions. Their expertise covers a broad spectrum of conditions, including end-stage renal disease (ESRD), dialysis patients, hepatic insufficiency, metabolic dysfunction-associated steatohepatitis (MASH), and cirrhosis. 

Leveraging strong partnerships with hospital departments, CRS accesses specialised facilities such as dialysis units and advanced medical imaging, enabling innovative trial designs that deliver rigorous data and high-quality outcomes, all while maintaining the highest clinical care standards.

Patient recruitment and accredited laboratory support

With direct access to a network of leading hepatologists, hepatology outpatient clinics, nephrologists, dialysis centers, and other specialist departments at UKSH (University Hospital Schleswig-Holstein), CRS ensures its studies adhere to the highest standards of care while advancing scientific innovation. This extensive network supports the rapid identification and recruitment of suitable study participants, including matched elderly controls, facilitating prompt study start-up and timely trial completion.

CRS also collaborates closely with the accredited medical laboratory Laboratorium für Klinische Forschung GmbH (LKF) to guarantee rapid turnaround of lab results. Combined with in-house blood and urine processing facilities, this partnership streamlines screening procedures and enables real-time safety monitoring across all studies.

Contact us

Contact us today to learn how our patient-centered approach and deep expertise in hepatology, nephrology and clinical development can support your trial success.

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