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 range18 Years

SexALL

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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.
✓. 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

What they're measuring

Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment

Timeframe: 2-5 yrs.

Trial details

NCT IDNCT01413074

SponsorVantive Health LLC

Sponsor typeINDUSTRY

Study typeINTERVENTIONAL

Primary completion2013-12

View on ClinicalTrials.gov More End Stage Renal Disease trials