Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China (NCT01413074) | Clinical Trial Compass
TerminatedNot Applicable
Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
China416 participantsStarted 2011-06
Plain-language summary
Primary Objective: The primary objective is to prospectively assess and compare survival in subjects with End Stage Renal Disease (ESRD) randomized to Peritoneal Dialysis (PD) or Hemodialysis (HD) treatment.
Secondary Objectives: The secondary objectives are to prospectively assess and compare the following parameters in subjects receiving PD or HD treatment:
* Technique failure
* Cause of death
* Comorbidity status at baseline and changes throughout the study
* Change in residual renal function (RRF)
* Dialysis adequacy (i.e., Kt/Vurea)
* Change in blood pressure, hemoglobin, and S-phosphate
* Change in nutritional status
* Occurrence of bacterial and other infections
* Hospitalization, including number, duration, and underlying reason(s)
* Systemic inflammation as assessed by high-sensitivity C reactive protein (hs-CRP)
* Quality of life (QOL)
Safety Objectives: To compare the nature and frequency of adverse events (AEs) and serious adverse events (SAEs), including abnormal laboratory test findings with clinical significance, in subjects receiving PD or HD treatment.
Who can participate
Age range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion criteria
. Subjects of either sex, aged 18 years or older at time of randomization.
. Subjects diagnosed with ESRD (glomerular filtration rate \[GFR\] ≤ 15 mL/min/m2 body surface area \[BSA\]) and predicted by the investigator to need dialysis therapy within 10 weeks after the pre-screening period.
. Subjects who, as judged by the investigator, are able to comprehend the pre-defined, standardized, modality education program and have undertaken this education during the screening period.
. Subjects, or their legal representative, who, as judged by the investigator, are capable of being trained for home-based PD.
. Subjects, or their legal representative, who are able to understand and voluntarily sign an ICF.
. Subjects who are able to adhere to the study visit schedule and other protocol requirements.
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
What they're measuring
1
Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment
. Subjects who are able to regularly visit a HD center for HD therapy (≥ 3 times per week).
. Subjects who, as judged by the investigator, are expected to remain on dialysis for at least 48 weeks.
Exclusion criteria
. Subjects who are HIV positive.
. Subjects who have already received a permanent PD catheter or HD access that is intended for permanent use before receiving modality education or have already received permanent dialysis. Subjects are not excluded if an access is present within 4 weeks before screening for back-up purposes or for acute treatment of life-threatening uremic symptoms, electrolyte abnormalities, or fluid overload.
. Subjects who have a serious, uncontrolled medical disorder or active infection, which, as judged by the investigator, would jeopardize their ability to receive the prescribed dialysis treatment.
. Subjects who have dementia or a mental status that would significantly affect the subject's understanding of the Informed Consent Form (ICF).
. Subjects who are pregnant, intend to become pregnant during the study period, or are breast-feeding.
. Subjects with a history of drug (defined as illicit drug use) or alcohol (defined as regular or daily consumption of more than 4 alcoholic drinks per day) abuse in the 2 years before screening.
. Subjects who have previously received renal transplantation and are still being prescribed immunosuppressive therapy.
. Subjects who are currently using or have used an investigational product within five half-lives of the physiological action or 30 days, whichever is longer, before screening.