The Laboratory of Advanced Stages of Drug Development in Humans is responsible for conducting clinical trials related to chronic kidney disease, with a focus on innovative drug protocols that can slow or halt the progression of rare or more common nephropathies and for which there is as yet no optimal or curative treatment.
In addition, clinical research work in this unit focuses on the advanced design of cell therapies to induce immunological tolerance to kidney transplantation in humans.
Activities
- Designing academic phase II and III monocentric/single-centre or multicentre national and international clinical trials
- Participating in international phase II and III clinical trials sponsored by the pharmaceutical industry
- Selecting eligible patients for clinical trials based on the inclusion and exclusion criteria in the protocol
- Periodic clinical and immunological monitoring of patients enrolled in the studies, according to the protocol
- Evaluating and following up on any adverse events during the course of the clinical trial
- Collecting blood and urine samples as stipulated in the clinical protocol for specific mechanistic studies to further investigate responses to a particular drug treatment or cell therapy (advanced genetic, immunological, and biochemical markers)
- Epidemiological-type activities related to chronic kidney disease, part of the international Global Burden of Diseases and Injuries (GBD) project and related national-level initiative (GBD Italy)