One year of PRIME-CKD: where are we now?
In April and May the consortium has had two important meetings: the annual consortium meeting and the annual stakeholder meeting. On April 25 and 26 over 40 consortium members met in beautiful Valencia (Spain) to meet each other and discuss the progress of the project.
Completion of the first clinical trial!
In work package 1 dr. Elisabeth Meister (UKE, Germany) reported a big step with the completion of the samples and data of 66 patients with varying stages of chronic kidney disease (stages 2, 3 and 4), both with and without diabetes. The coming months the samples will be analyzed to determine for instance how often urine should be measured to distinguish a true drug response from random variability. But also, to determine if 24-hour urine or spot urine samples should be used. These results are of critical importance to close the gap between biomarker research and clinical implementation of biomarker-guided treatment.
Watch the video with highlights from the annual meeting in Valencia.
Building on previous research
In work package 2 Dr. Wenjun Ju (University of Michigan, USA) focuses on results of previous trials in other research programmes. With the samples collected in these trials (such as plasma, serum, urine, genetics and kidney biopsies) new measurements will be done in order to validate the biomakers clusterin and EGF (epidermal growth factor).
CTIS registration completed
In work package 3 PhD-student Marte Opseth Rygg (Steno Center Kopenhagen, Denmark) reported about the important work she did for the approval of the CKD-bioMatch trial. Because clinical studies are being conducted in various countries this is a lengthy and complicated process. In the CKD-bioMatch trial we will compare standard care (current care according to guidelines) with a biomarker guided form of care. We expect the trial to start around the summer of 2024.
Registration and implementation
Next to all the scientific work being done in PRIME-CKD the participants talked about the ways to come to registration and qualification of biomarkers with regulatory agencies. This is a necessary step towards implementing a biomarker guided treatment of patients with chronic kidney disease. The participation of stakeholders (such as patients, doctors, other companies and health care systems) is another important part of the project.
Stakeholders got together
Therefore we organised an online meeting on May 15th to inform stakeholders about the progress of the project and answer their questions. Constructive feedback was given of the role of primary care physicians in the different work packages and the importance of patient representation was further underlined.
The patient’s representatives called upon the consortium leaders to develop a practical biomarker guided therapy. Or as someone put it: “The very best is not always the most practical”. Indeed for true implementation of our research findings it is crucial to work towards a method that is practical in use for both doctors and patients.
In conclusion, a lot of preparatory for all the clinical trials and other activities has been done in the first 1,5 year of the project. We will continue to share results with you! Please follow our LinkedIn-page or website to stay informed.
