Dear Partners,

Thank you for your participation in the first meeting of the CLIgAN project, held at the Palazzo dei Congressi in Rimini on the occasion of the 63rd National Congress of the Italian Society of Nephrology, I am sending a summary of what was discussed.
The non-profit project approved by AIFA was illustrated to the participating Centers.
The study represents the first randomized clinical trial that takes into consideration the histological findings of the kidney biopsy after the diagnosis made with immunofluorescence which highlights mesangial deposits of IgA. Based on the presence of active, chronic or moderate renal lesions with eGFR ≥ 30 ml/min/1.73m2 and proteinuria ≥ 0.5 g/24 hours patients will be enrolled in the study with different therapies. Patients with active lesions will receive therapy within 2 weeks of the kidney biopsy and those with chronic or moderate lesions within four weeks of the biopsy.
The study will start after the approval of the Coordinating Ethics Committee and the Local Ethics Committee.
The Contract Research Organization (CRO) CRT (Clinical Research Technology) of Naples, with which you have already had contact, will contact the Directors of the Centers to complete the bureaucratic process of the study. After the approval by the Ethics Committee and the patient's informed consent, the patients will be enrolled by contacting the eResult Company that oversaw the eCRF (electronics case report form) and will carry out the patient randomisation. It is desirable that each Center be able to enroll 15 actual cases of patients with documented IgAN. If the enrollment proceeds in a short time, we will have the possibility to see the effect of therapy on proteinuria (primary outcome) and on renal function (secondary outcome) which will be evaluated with the slope over time.
As regards the prescription of Dapagliflozine, I have received news that by the end of November AIFA should give the authorization to prescribe the drug to non-diabetic patients suffering from CKD.
It is recommended that the practical conduct of the study be entrusted to young doctors who can follow the study throughout its duration.
It has been decided to adopt a common protocol for the processing of the kidney biopsy and the reading of the tissue sections. The technical news of the CLIgAN study will be sent after the approval of the Local Ethics Committee. However, I have attached the model to be filled in for reading the kidney biopsy. This will reduce biases that could affect the outcome of the CLIgAN study.
The Peer Reiew process on the kidney biopsies will be performed by 3 centers which are located in Monza, Bari and Los Angeles. The Peer review process is essential for the purpose of publishing the data obtained with the study because it is required by all scientific journals.
A website will be set up where, through personal access, it will be possible to obtain all the technical news and follow-up data of one's patients who will have a code in order to respect anonymity.
Finally, it has been specified that non-responsive patients may be subjected to a second kidney biopsy in order to be able to adopt further therapeutic measures with drugs already available; however, they cannot be randomized for or enter in other experimental studies. While waiting to move on to the implementation phase, I send you my best regards

F.P. Schena
Mob. 3336771291
E-mail: paolo.schena@uniba.it