Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 4:54 PM
Ignite Modification Date:
2025-12-24 @ 4:54 PM
NCT ID:
NCT02378350
Brief Summary:
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire domain of burden of kidney disease.
Secondary Objectives: The secondary objectives are to observe and summarize the following parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items, which will be compared between the 2 treatment groups:
* Mortality rates
* Switch (PD to HD or HD to PD)
* Transplantation rate
* Cause of death
* Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the volume of distribution of urea \[Kt/V urea\] to determine the proportion of subjects meeting standards of care for dialysis adequacy).
* 24-hour urine volume
* Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values within the target range
* Change in serum albumin
* Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Study:
NCT02378350
Study Brief:
Protocol Section:
NCT02378350