Introduction:
Chronic kidney disease (CKD) is a pressing global health concern affecting more than 800 million people. Over the last decade, several new therapies have been identified that have shown efficacy in reducing albuminuria and/or clinical kidney endpoints in patients with CKD with and without type 2 diabetes. There are several ongoing clinical trials testing the efficacy and safety of additional novel interventions, which provide an opportunity to develop infrastructure that allows rapid identification of patients who are eligible and interested in participating in interventional clinical trials. Here we describe the design and baseline results of the Global Kidney Patient Trials Network (GKPTN).
Methods:
The GKPTN is an ongoing multicenter registry of patients with non-dialysis CKD of different disease etiologies. It aims to recruit patients interested in participating in interventional clinical trials and to monitor their long-term treatment and clinical outcomes. It has been endorsed by the International Society of Nephrology. All incident and prevalent patients diagnosed with CKD at participating centers are eligible for inclusion. Baseline demographic data including age, sex, cause of kidney disease, current treatments, other relevant medical conditions, and pathology data including estimated glomerular filtration rate (eGFR), albuminuria, cardiac biomarkers are collected from patient records by site staff at the time of recruitment after consent. Follow-up data, including eGFR, albuminuria and clinical kidney and cardiovascular outcomes are collected from medical records during routine clinical care visits.
Results:
The GKPTN has enrolled 4334 patients since May 2020 across 119 sites in 8 countries (United States, Australia, Argentina, China, Italy, Canada, Spain and Japan). The mean participant age (Standard Deviation) at enrolment was 64.5 (16.2) years, 2542 (58.7%) were female, 1875 (43.3%) participants had diabetic kidney disease, mean eGFR was 52.9 (29) mL/min/1.73m2, and median Urine Albumin Creatinine Ratio (interquartile range) was 89 (20, 420) mg/g. Most participants were Caucasian (N=2267,52.3%), followed by Latino-Americans (N=866, 20.0%), Black or African American (N=624, 14.4%) and Asians (N=533, 12.3%). Geographically, most patients were recruited from North America (60.5%), followed by Europe (13.2%), South America (10.9%), and Asia (10.7%). With regards to kidney protective therapies, renin angiotensin aldosterone inhibitors were used in 3145 (72.6%) participants at baseline, while sodium glucose co-transport inhibitors were used in 579 (13.3%) participants. During 0.89 (0.50, 1.44) median years of follow-up, the mean annual eGFR change was -1.7 (95%CI -2.3, -1.0) mL/min/1.73m2. The rate of eGFR decline did not vary among age or sex specific subgroups with the steepest decline in people with baseline eGFR≥60 mL/min/1.73m2.
Conclusions:
The GKPTN has successfully recruited more than 4000 patients with a diverse patient population. The range of countries supports that future findings from the GKPTN are generalizable to patients around the world. The data allow descriptions of nephrology practices around the world and highlight that use of kidney protective therapies such as renin-angiotensin aldosterone inhibitors could be optimised.
I have no potential conflict of interest to disclose.
I did not use generative AI and AI-assisted technologies in the writing process.