Impact of Recent Clinical Trials on Nephrology Practice: Are We in a Stagnant Era?

Abstract

Background: Although renal replacement therapy prevents death from uremia, survival among patients with acute and chronic kidney diseases (CKD) remains an imperative concern. The expected life span of US dialysis patients 60–64 years of age is approximately 4.5 years; this is similar to that of patients with lung cancer. Despite substantial progress in many medical specialties over the past decades (e.g., notable reductions in myocardial infarction, stroke, and mortality rates in the general population), survival among dialysis patients has not improved significantly over the same period. A few decades ago, HIV infection and AIDS were pretty much a death sentence. Because of progress in HIV treatment, now it can be controlled with a daily pill, and ongoing research is pushing treatment even further and controls the virus with longer-acting treatment. A cure is no longer impossible for HIV and other viral infections such as hepatitis B and C and many malignancies, but so far there is no cure for CKD. Summary: Billions of dollars have been spent on kidney disease research in the past decades, with no tangible progress in clinical practice. The challenges of improving the quantity and quality of trials in nephrology are enormous. The number of randomized controlled trials (RCTs) published in nephrology is lower than that in other medical subspecialties, and most of the big RCTs in nephrology yield negative results. Nephrology studies evaluating hard clinical endpoints or surrogate endpoints are scarce. Key Message: Herein we discuss the slow progress in nephrology research that has impacted clinical practice over the last couple of decades and highlight the major obstacles, challenges, and potential solutions.

Trends in Adaptive Design Methods in Dialysis Clinical Trials: A Systematic Review

“…The comparatively low number of trials are postulated to be due to difficult recruitment, previous history of underpowered trials and lack of funding (4,5). Although the number of trials are increasing, nephrology continues to lag behind other specialities such as cardiology, haematology/oncology and gastroenterology (6,7).…”

Predictors of Survival in Chronic Hemodialysis Patients: A 10-Year Longitudinal Follow-Up Analysis

“…One obstacle hindering this improvement is that observing hard outcomes is time consuming in the field of nephrology [2]. Therefore, most research on the prognosis is based on retrospective observational studies.…”

Emperor’s syndrome in the COVID-19 era: Time for patient-centered nephrology?

“…Apart from this foreseen emerging treatment, the field of nephrology regarding CKD management suffers from stagnation, due mainly to a lack of robust clinical trials for clinically meaningful endpoints, or lack of positive results[ 5 ]. There are also factors inherent to CKD, such as the high percentage of older patients with many comorbidities who are excluded from randomized controlled trials[ 6 ], and the complex pathophysiology of the interaction of heart kidney adverse outcomes[ 7 ].…”