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Kidney Toxicity


  • Kidney toxicity assays
  • Renal drug safety evaluation


  • aProximate™ kidney proximal tubule cells (static)
  • Glomerulus podocyte cells


  • 2-3 months

Predictive and investigative kidney toxicity and drug safety evaluation, in vitro

Drug-induced nephrotoxicity is one of the leading causes of drug failure as the prediction of kidney toxicity during new drug development remains inaccurate. Therefore, early detection of  is key to reducing both costs and timelines. The FDA recommends in vitro nephrotoxicity assessment of new drugs and biologics prior to in vivo assessments in animal models. Additional regulatory guidance from both the FDA and EMA also recommends the detection of early markers of kidney toxicity such as KIM-1 and clusterin, which can only be quantified in more complex in vitro nephrotoxicity models. Such models are therefore needed for reliably predictive and early evaluation of renal safety profiles. Newcells aProximate™ proximal tubule cell model and glomerulus model are the ideal tools for assessing renal toxicity.

Service outputs

  • aProximate:
    Assessment of FDA-approved biomarkers of kidney toxicity: KIM-1, NGAL and clusterin
    Cell viability: ATP, LDH and TEER measurements
  • Glomerulus podocyte model:
    Permeability of 70 kDa FITC-dextran (increased podocyte permeability)
    Cell viability: ATP and TEER measurements
  • Customised outputs

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Full safety profile

Multiple species


Newcells kidney tissue models

Accelerate your lead compound selection by understanding their mode of action in kidney tissue.


Fully differentiated and polarised kidney proximal tubule and podocyte cells


Measurement of FDA-approved renal toxicity biomarkers


High predictivity of in vivo and clinical outcomes

Example: In vitro nephrotoxicity screening Close Open

The aProximate™ model has been used in a collaborative drug safety evaluation study with Takeda Pharmaceuticals. The study used 36 compounds with known in vivo safety profiles (toxic or non-toxic) using aProximate™ PTCs as a training set. FDA-qualified kidney-specific biomarkers of kidney toxicity such as KIM-1, NGAL and clusterin can be detected in the model, confirming its suitability to assess renal toxicity and evaluate renal drug safety during drug discovery. The model was then used to assess other compounds and correctly classified four of six true positives and two of three true negatives, showing validation of the in vitro nephrotoxicity model for detection of tubular toxicants. This work thus shows the potential application of quantifying translational biomarkers in freshly isolated aProximate™ PTCs for the assessment of nephrotoxicity within the drug discovery pipeline.

Renal toxicity graphs
High content comparison of two compounds for drug safety prediction using aProximate™ PTCs, indicating a possible nephrotoxic effect for compound B with increased levels of injury biomarkers and decrease of non-specific injury end points. Compound A is predicted as non-toxic.


Freshly isolated primary human proximal tubule cells as an in vitro model for the detection of renal tubular toxicity

View Publication
Service overview Close Open

Our service provides insights into drug-induced nephrotoxicity:

Newcells offers a full in vitro kidney toxicity evaluation by testing your compounds of both the podocyte model and aProximate™. Evaluation of both the glomerulus (for early damage) and proximal tubule, in vitro will give a full assessment of the renal safety profiles of your compounds, significantly accelerating your drug safety studies.

The data generated from our renal toxicity assays provides a comprehensive understanding of the safety profile of your compounds by testing parameters which follow regulatory guidelines, giving you confidence in your lead candidates ahead of further in vivo animal testing.

aProximate™ also allows the assessment of nephrotoxicity across a range of pre-clinical species such as mouse, rat and dog to help you identify the most appropriate in vivo model for your compound.

Our project timelines are short due to our regular supply of fresh kidney tissue. The robust data generated by our scientific experts will guide you in confidence for key decision-making steps during drug development.

An example of renal toxicity packages includes assessment of FDA-approved biomarkers (KIM-1, NGAL and clusterin) in our aProximate™ proximal tubule cell model and permeability of FITC-dextran in our glomerulus podocyte model. Both kidney tissue models can be used to assess drug-induced cell health and monolayer integrity. Data can be aquired from three separate biological donor kidneys across multiple species.

Assay design

aProximate™ primary isolated kidney proximal tubule cells (static)

Glomerulus podocyte cells

Assay format

96-well Transwell® plates

  • Human
  • Mouse
  • Rat
  • Dog
  • Non-human primate
Assay readout
  • Assessment of FDA-approved biomarkers of renal toxicity: KIM-1, NGAL and clusterin (aProximate™ only)
  • Permeability of 70 kDa FITC-dextran (podocyte cells only)
  • Cell viability: ATP, LDH and TEER measurements
Time points and replicates
  • 0, 24H up to 3 days, multiple dosing
  • Data points are usually performed in triplicates


A microscope image of a nephron model
Zo-1 Immunocytochemistry staining of PTCs (red) and Hoescht nuclear staining.
Kidney podocin
Podocyte immunostaining for podocin and CD2AP

Models to choose from for this service

aProximate™ proximal tubule cells

aProximate™ is one of the most advanced, near physiological, in vitro, kidney proximal tubule cell (PTCs) models. aProximate™ PTCs are derived from fresh human kidney tissue and grown on Transwells® where they remain well differentiated as a polarised cell layer forming tight junctions.

Find out more
A microscope image of a nephron model

Glomerulus model

The first fully differentiated, primary podocyte model derived from human kidney tissue. The effect of a drug on the glomerular filtration barrier and the podocyte glomerular permeability can now be easily evaluated in vitro. Podocyte injury and proteinuria can be modelled in vitro at high throughput and assessed by measuring podocyte damage biomarkers, TEER and podocyte permeability.

Find out more
A microscope image of a convoluted tubules

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