Comparison of the Impact of Dialysis Treatment Type on Patient Survival

refer to brief summary

Inclusion criteria

• Male or female patients who are at least 18 years of age.
• Patients who have read, understood and given written informed consent after the nature of the study has been explained.
• Patients who have a diagnosis of ESRD (GFR ≤ 10 ml/min), without a permanent access for dialysis.
• Patients who are able to comprehend a modality education program.
• Patients who are judged as capable of being trained for home based PD.
• Patients as justified by their physicians requiring dialysis treatment within 6 weeks after randomization (Patients who require urgent temporary dialysis before randomization may also be eligible for recruitment after being stabilized with temporary HD or PD)
• Patients who are expected to remain on dialysis for at least 6 months.
• Patients must have a negative HIV test at screening. -

Exclusion criteria

• Patients that have already received a permanent catheter or access that is intended for permanent therapy use before receiving modality information, or have already received permanent dialysis (If an access is present within 4 weeks prior to screening for back-up purposes, or for acute treatment for life threatening uremic symptoms, electrolyte abnormalities or fluid overload, this does not exclude the patient from enrollment).
• Patients who previously have received renal transplantation and are still prescribed immunosuppressive therapy.
• Patients who are unwilling or unable to follow the protocol.
• Patients with concomitant participation in any other interventional study, or who have received any investigational drug, biologic or device within five half-lives of the physiological action or 30 days, whichever is longer, prior to screening.
• Patients justified as not eligible for either PD or HD due to:

• PD: documented extensive intra-peritoneal adhesions, severe infective skin disorder, or other situation contradicting PD (eg., active inflammatory bowel disease)
• HD: severe cardiac instability and inability to a gain permanent vascular access.
• Patients who have a history of drug or alcohol abuse within the six months prior to entering the study
• Patients who have active systemic infections, such as tuberculosis, septicemia or systemic fungal infections.
• Patients who have malignancies requiring active chemotherapy or radiation therapy.
• The presence of other terminal illness likely to cause death within 6 months
• Patients who have any other serious acute or active conditions that in the investigator's opinion would preclude their participation in the study.
• Female patients who are pregnant, lactating or planning on becoming pregnant during the study period.
• Patients who are allergic to starch-based polymers, maltose or isomaltose
• Patients who have glycogen storage disease.
• Patients who have a significant psychiatric disorder or mental disability that could interfere with the patient's ability to provide informed consent and/or comply with protocol procedures -