End Stage Renal Disease
Conditions
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
Interventions
DEVICEHemodialysis treatment (no specific device is defined)
DRUGPeritoneal Dialysis treatment (no specific drug is defined)
Sponsors
Baxter Healthcare Corporation
Vantive Health LLC
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to No maximum
Healthy volunteers
No
Inclusion criteria
1. Subjects or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF) 2. Male or female subjects aged 18 years or older at the time of randomization 3. Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF 4. Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF 5. Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD 6. Subjects who are able to adhere to the study visit schedule and other protocol requirements 7. Subjects who are able to come to HD clinics as required by the protocol 8. Subjects who, as judged by the Investigator, are expected to remain on dialysis for at least 48 weeks 9. Subjects who have normal liver function, as judged by the Investigator 10. Female subjects of childbearing potential must have negative serum or urine pregnancy test at Screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the Investigator, while in the study
Exclusion criteria
1. Subjects who are HIV positive 2. Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤4 weeks before Screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities or fluid overload 3. Subjects who have an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study 4. Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening 5. Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy 6. Subjects who are currently using any investigational drug 7. Subjects who are currently enrolled in other clinical studies 8. Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol 9. Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to: * Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated * Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated 10. Subjects who have a malignancy requiring chemotherapy or radiation therapy 11. Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration 12. Subjects who have a life expectancy of \< 48 weeks
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire | 1 year |
Secondary
| Measure | Time frame |
|---|---|
| Switch (PD to HD or HD to PD) | 1 year |
| Transplantation rate | 1 year |
| Cause of death | 1 year |
| Dialysis adequacy | 1 year |
| Mortality rates | 1 year |
| Change in hemoglobin | 1 year |
| Change in serum albumin | 1 year |
| Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance | 1 year |
| Change in S-phosphate levels | 1 year |
| 24-hour urine volume | 1 year |
Countries
China
Outcome results
None listed