Groups aim to include patients with CKD in clinical trials

Although the disease affects 850 million people worldwide, patients with chronic kidney disease are still excluded from clinical trials, according to a press release from the European Renal Association – European Dialysis and Transplant Association.

Many therapies cannot be authorized by regulatory authorities for this subgroup of patients, according to the release, meaning these therapies cannot be prescribed for patients with chronic kidney disease.

“The fact of the matter is that many innovative treatments fail to reach our patients,” Carmine Zoccali, CNR-IFC, president of the European Renal Association – European Dialysis and Transplant Association (ERA EDTA), said in the release. “Let’s take [sodium-glucose Cotransporter] SGLT inhibitors, a new group of antidiabetic drugs, as an example. We know from studies that these substances may protect kidney function, but they have not been tested in CKD patients with an eGFR below 30 ml/min. This means that kidney patients are excluded from therapies that might slow down the progression of CKD.”

According to the release, CKD is bidirectionally linked to health risks including cardiovascular disease and diabetes, making it crucial that these patients are eligible for the latest treatments. Furthermore, cancers or treatments targeting cancers may also aggravate CKD.

“It is a fact that the efficacy and the safety of treatments tested on patients without CKD cannot be assumed in CKD patients, and similarly that withholding treatment due to the presence of CKD may significantly and unfairly disadvantage those affected,” David Harris, past-president of the International Society of Nephrology, said in the release. “We need studies that include CKD patients.”

Driven by this issue, the International Society of Nephrology tasked the research community with enrolling 30% of patients with CKD by 2030, encouraging their inclusion and ensuring patients receive equal opportunity to receive evidence-based prevention and the latest treatments.

The Kidney Health Initiative, a partnership between the American Society of Nephrology’s and the FDA, addresses this issue with its “Overcoming Barriers to Including Kidney Disease Patients in Cardiovascular Trials,” which aims to understand the barriers to enrolling patients with CKD into cardiovascular trials and identifying strategies to overcome these challenges.

According to the release, the ERA EDTA has maintained a registry of dialysis and transplantation in Europe since 1964. This registry has extended its research to pre-dialysis CKD by establishing a consortium of existing CKD cohorts in Europe and, in recent years, the ERA EDTA has directly funded clinical trials in patients with renal diseases and those on dialysis.

Reference:

www.era-edta.org/190709_Press%20Release-ERA-ASN-ISN-Clinical%20Trials-Nephrology.pdf