Patients enrolled in the study were randomly assigned to the treatment or the control groups. At baseline, the study groups were equivalent with respect to demographic characteristics (age and gender), etiology of renal disease and prevalence of co-existing conditions (e.g., diabetes), as well as blood tests and physical examination measures (e.g., blood pressure, weight, height).
The clinical study design was successful in achieving the intended separation in peritoneal creatinine clearance measurements, which were higher in the intervention group, and in sustaining this separation throughout the course of the study. On average, the two groups were separated by a highly significant difference of 11 liters of creatinine clearance with no difference in survival between the two groups. In addition, significant separation was also achieved between the two groups relative to urea Kt/V, another measure of small solute clearance (control group peritoneal Kt/V averaged 1.62 vs. 2.13 for the treatment group), with no resulting difference in survival rates.
Treatment Options for People with Kidney Disease
It is expected that the number of people with ESRD is growing at about 7 to 8 percent annually. Declining kidney function results in higher levels of toxins and waste products in the blood. When the kidneys no longer adequately eliminate toxins from the bloodstream, dialysis helps to remove these unwanted substances from the body.
Two treatment options are available to patients with ESRD: transplantation and dialysi
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Contact: Stephanie Lazor
Stephanie.Lazor@mslpr.com
212-213-77265
Manning Selvage & Lee
18-Apr-2002