Comparison of the Impact of Dialysis Treatment Type on Patient Survival
Comparison of the Impact of Dialysis Treatment Type on Patient Survival
As the influence of type of dialysis on survival of end stage renal disease (ESRD) patients
 remains unanswered, the present study is designed (randomized, prospective, multicenter,
 interventional) to assess clinical outcomes, and compare mortality, morbidity, Quality of
 Life (QOL) and cost effectiveness between maintenance In-center Hemodialysis (ICHD) and
 Continuous Ambulatory Peritoneal dialysis (CAPD). These data will ultimately bring clarity on
 whether or not any difference in patient survival exists between the two modalities.

 In order to test the feasibility of patients' willingness to be randomized to two different
 modality groups and retained in the randomized group, a pilot study is planned before the
 conduct of a main study.

 This pilot study comprises of a 6 months study, plus a 6 months observation if there is
 possibility to switch the patients into the main study.

 All ESRD patients requiring dialysis treatment within 8 weeks after a pre-study visit will be
 recorded in each site. Patients who provide written inform consent for collecting relevant
 information will be screened using certain inclusion/exclusion criteria. Eligible patients
 will undergo a standardized education regarding ESRD and treatment options. Thereafter the
 patient will be required to provide a second inform consent allowing for randomization and
 entrance into the study. Eligible patient will be randomized to either PD or HD treatment.

 The patients will be followed for a period of 6 months, during which patients will be treated
 with PD or HD as prescribed at each site, while meeting the dialysis adequacy and other
 indicators. For the first 3 months monthly visits are required, after which an every 3 months
 visit is planned.

 In this pilot study, the main objective is to assess the willingness of ESRD patients to be
 randomized to either PD or HD treatment; thereby determining if an adequate number of
 eligible patients can be recruited for a future large-scale study.
refer to brief summary
Inclusion Criteria:

 1. Male or female patients who are at least 18 years of age.

 2. Patients who have read, understood and given written informed consent after the nature
 of the study has been explained.

 3. Patients who have a diagnosis of ESRD (GFR ≤ 10 ml/min), without a permanent access
 for dialysis.

 4. Patients who are able to comprehend a modality education program.

 5. Patients who are judged as capable of being trained for home based PD.

 6. 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)

 7. Patients who are expected to remain on dialysis for at least 6 months.

 8. Patients must have a negative HIV test at screening. -

 Exclusion Criteria:

 1. 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).

 2. Patients who previously have received renal transplantation and are still prescribed
 immunosuppressive therapy.

 3. Patients who are unwilling or unable to follow the protocol.

 4. 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.

 5. 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.

 6. Patients who have a history of drug or alcohol abuse within the six months prior to
 entering the study

 7. Patients who have active systemic infections, such as tuberculosis, septicemia or
 systemic fungal infections.

 8. Patients who have malignancies requiring active chemotherapy or radiation therapy.

 9. The presence of other terminal illness likely to cause death within 6 months

 10. Patients who have any other serious acute or active conditions that in the
 investigator's opinion would preclude their participation in the study.

 11. Female patients who are pregnant, lactating or planning on becoming pregnant during
 the study period.

 12. Patients who are allergic to starch-based polymers, maltose or isomaltose

 13. Patients who have glycogen storage disease.

 14. 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 -