Kidney Week

Abstract: FR-PO435

Representativeness of Populations Recruited in Randomized Controlled Trials of Hemodiafiltration vs. Hemodialysis: A Systematic Analysis in Comparison with Representative Registry Data

Session Information

• Hemodialysis Epidemiology and Outcomes
  October 25, 2024 | Location: Exhibit Hall, Convention Center
  Abstract Time: 10:00 AM - 12:00 PM

Category: Dialysis

• 801 Dialysis: Hemodialysis and Frequent Dialysis

Authors

• Yuen, Tom, Fresenius Medical Care Asia Pacific Ltd, Hong Kong, Hong Kong

Tom Yuen

• Pham, Ngoc, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Ngoc Pham, MSc

• Ho, Kakiu, Fresenius Medical Care Asia Pacific Ltd, Hong Kong, Hong Kong

Kakiu Ho

• Stauss-Grabo, Manuela, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Manuela Stauss-Grabo, PhD

• Strippoli, Giovanni, Universita degli Studi di Bari Aldo Moro, Bari, Puglia, Italy

Giovanni Strippoli, MD, PhD, MBA

• Cromm, Krister, Fresenius Medical Care Deutschland GmbH, Bad Homburg, Hessen, Germany

Krister Cromm, MA, MS, MSc, MBA

Group or Team Name

• CONVINCE Scientific Committee and CONVINCE Investigators.

Background

The external validity of randomized controlled trials (RCTs) depends on the comparability of involved populations to the ones in “real life”, whose data are usually reported in registries. Following the recent publication of the CONVINCE trial, we compared patient baseline characteristics in all existing RCTs of hemodiafiltration (HDF) vs hemodialysis (HD) and with data of key renal registries from Europe, Australasia and America. Our aim was to ascertain existing heterogeneity and whether the coverage in RCTs was representative of prevalent registry populations.

Methods

We performed a systematic search for RCTs of HDF vs HD using Cochrane methodology (1966 to current). We also searched for annual reports of representative registries (2020-2023). For both RCTs and registries we extracted data on patient characteristics (age, sex, diabetes, cardiovascular disease, vascular access). We compared data between RCTs and registries using visual analysis, descriptive statistics and heterogeneity statistics (I²).

Results

Thirteen RCTs including CONVINCE and 8 registries were identified. There was substantial heterogeneity for all characteristics within RCTs, substantiating that a large and broadly representative array of people are enrolled in existing RCTs of HDF vs HD. These were in line with registry populations for age, proportion of diabetic patients and sex (p=not significant) but not for cardiovascular disease and proportion having a fistula for vascular access (p<0.05).

Conclusion

There was significant heterogeneity in the patient characteristics of existing RCTs of HD vs HDF. Overall, the data are representative of populations reported in registries of different geographies. While individual trials may appear as outliers compared to the prevalent registry population, the totality of evidence covers a broad spectrum of the end stage kidney disease population receiving renal replacement therapy either as HD or HDF. The similarity between characteristics of patients in RCTs and registries supports that existing RCTs adequately represent the real-life population.

Funding

• Government Support – Non-U.S.