Fresenius Medical Care Holdings, Inc.

Franz Kappel

Peter Kotanko

Stephan Thijssen

Doris Helene Fuertinger

Nathan W Levin

Alice Topping

Doris Fuertinger

Aurelio A De Los Reyes, V

Anna Meyring-Wosten

Aurelio A De Los Reyes V

Doris H Fuertinger

Techniques and apparatus for generating, performing, and evaluating virtual clinical trials that include clinic modules to represent real-world operational aspects of trial entities are described. In one embodiment, for example, an apparatus may include at least one memory, and logic coupled to the at least one memory. The logic may be configured to generate a plurality of avatars configured to model a health condition associated with a population of patients, and to perform a virtual clinical trial to simulate a course of treatment for the plurality of avatars, the virtual clinical trial to include at least one clinic module associated with at least one event and a probability for the at least one event, the at least one event to model an operational aspect of an entity of the virtual clinical trial. Other embodiments are described.

Techniques for conducting virtual clinical trials

A method includes: receiving measurements of a blood-related parameter corresponding to a patient undergoing hemodialysis; estimating a value of one or more hemodialysis treatment-related parameters by applying a vascular refill model based on the received measurements of the blood-related parameter, wherein the one or more hemodialysis treatment-related parameters are indicative of an effect of vascular refill on the patient caused by the hemodialysis; determining, based on the one or more estimated values of the one or more hemodialysis treatment-related parameters, a hemodialysis treatment-related operation; and facilitating performance of the treatment-related operation. The vascular refill model is a two-compartment model based on a first compartment corresponding to blood plasma in the patient's body, a second compartment based on interstitial fluid in the patient's body, and a semi-permeable membrane separating the first compartment and the second compartment.

System for analyzing vascular refill during short-pulse ultrafiltration in hemodialysis

Described herein are computer systems and methods for generating, in silico, one or more virtual patients. The one or more virtual patients can be used, for example, to conduct a virtual clinical trial, such as to determine an efficacy of a therapy or medical device. The one or more virtual patients mathematically represent a physiological system in an actual patient for a health condition. Also, the one or more virtual patients can be used, for example, to determine an adverse effect from a therapy or any other deviation from a therapy, or compliance of a patient suffering from a health condition on a therapeutic protocol.

System and method of conducting in silico clinical trials

A method of adjusting a patient's undesired hematocrit and/or hemoglobin concentration to a value within a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen includes obtaining patient parameters required for input into a model for predicting the patient's hematocrit and/or hemoglobin concentration at a predetermined time with a selected ESA administration regimen, and employing the patient parameters and an initially selected EPO administration regimen in the model to predict the patient's hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen. Optionally, if the patient's hematocrit and/or hemoglobin concentration is not predicted by the model to be in the desired range at the predetermined time, the method includes employing the model with one or more different ESA administration regimens until the model predicts that the patient's hematocrit and/or hemoglobin concentration will be in the desired range at the predetermined time. The method then includes administering ESA to the patient with an ESA administration regimen predicted to adjust the patient's hematocrit and/or hemoglobin concentration to the desired range at the predetermined time. The method can be implemented in a computer system for adjusting a patient's undesired hematocrit and/or hemoglobin concentration to a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen.

System and method of modeling erythropoiesis and its management

A method of adjusting a patient's undesired hematocrit and/or hemoglobin concentration to a value within a desired range at a predetermined time with an erythropoiesis stimulating agent (ESA) regimen includes obtaining patient parameters required for input into a model for predicting the patient's hematocrit and/or hemoglobin concentration at a predetermined time with a selected ESA administration regimen, the model including iron homeostasis, and employing the patient parameters and an initially selected ESA administration regimen in the model to predict the patient's hematocrit and/or hemoglobin concentration at the predetermined time with the initially selected ESA administration regimen. The method then includes administering ESA to the patient with an ESA administration regimen predicted to adjust the patient's hematocrit and/or hemoglobin concentration to the desired range at the predetermined time. The method can be implemented in a hemodialysis system.

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Graz, Austria

Franz Kappel