Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
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|ClinicalTrials.gov Identifier: NCT01413074|
Recruitment Status : Terminated
First Posted : August 10, 2011
Last Update Posted : May 19, 2016
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.
|Condition or disease||Intervention/treatment||Phase|
|End Stage Renal Disease||Other: Peritoneal Dialysis treatment Other: Hemodialysis treatment||Phase 4|
|Study Type :||Interventional (Clinical Trial)|
|Actual Enrollment :||416 participants|
|Intervention Model:||Parallel Assignment|
|Masking:||None (Open Label)|
|Official Title:||A Prospective, Randomized, Multicenter, Open-Label, Interventional Study Comparing Survival in Subjects Receiving Peritoneal Dialysis vs Hemodialysis in China|
|Study Start Date :||June 2011|
|Primary Completion Date :||December 2013|
|Study Completion Date :||December 2013|
Active Comparator: ESRD patients receiving HD treatment
no investigational drug involved. Only oberseve therapy treatment
Other: Hemodialysis treatment
Experimental: ESRD patients receiving PD treatment
no investigational drug involved. Only oberseve therapy treatment
Other: Peritoneal Dialysis treatment
- Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment [ Time Frame: 2-5 yrs. ]
- Assess and compare technique failure [ Time Frame: 2-5 yrs. ]Technique failure is defined as a change of dialysis modality (PD to HD, or HD to PD) or death. However, a temporary transfer, defined as ≤ 6 weeks duration and ≤ 2 occasions per any 52-week period, will not be considered technique failure. The use of both modalities within a 7-day period for more than 4 consecutive weeks will be considered technique failure. Technique failure will be monitored in two ways: modality failure including deaths and technique failure not including deaths.
- Residual Renal Function (RRF) [ Time Frame: 2-5 yrs ]RRF will be estimated if the subject's urine volume is ≥ 100 mL/24 h. RRF will be assessed by calculating GFR from a 24-h urine urea and creatinine collection and normalized to 1.73 m2 Body Surface Area. RRF will be measured at screening, visit 1 and every 12 weeks after visit 1 till the end of the study. Subjects who have a permanent modality transfer will be followed up for RRF (with the frequency of assessment determined by the modality they are switched to) until the end of the study, transplantation, stopping dialysis, lost to follow-up, or death.
- Dialysis Adequacy [ Time Frame: 2-5 yrs. ]In subjects receiving PD, dialysis adequacy (Kt/Vurea) will be assessed at 4 weeks (visit 2), 12 weeks (visit 4) and then every 12 weeks (±14 days) until the end of the study (±14 days). Kt/Vurea target for PD patients is ≥ 1.7 per week. Kt/Vurea target for HD patients is ≥ 1.2 per dialysis session. Subjects who have a permanent modality transfer will be followed up for Kt/Vurea (with the frequency of assessment determined by the modality they are switched to) until the end of the study, transplantation, stopping dialysis, lost to follow-up, or death.
- Co-morbidity Assessment [ Time Frame: 2-5 yrs. ]The Charlson Comorbidity Index contains 19 categories of comorbidity which are primarily defined using ICD-9-CM diagnoses codes, as well as a few procedure codes. The overall comorbidity score reflects the cumulative increased likelihood of one-year survival; the higher the score, the more severe the burden of comorbidity. Every diagnosis and procedure code is analyzed to see if it falls within one of the 16 comorbid conditions. In this study, the comorbidity assessment will be measured at visit 1, every 24 weeks (±14 days) after visit 1 to visit 23, and at the end-of-study visit.
- Occurrence of Bacterial and Other Infections Infection rates [ Time Frame: 2-5 yrs. ]Occurrence of bacterial and other infections infection rates, especially regarding exit sites and peritoneal, will be monitored for HD and PD patients.
- Hospitalization [ Time Frame: 2-5 yrs. ]Hospitalization rates and duration for each underlying reason will be monitored for HD and PD patients.
- Transplantation Rate [ Time Frame: 2-5 yrs. ]Kidney transplantation is the best outcome that a patient can expect. By default, a patient will be discontinued from the study after transplantation. Imbalance of the transplantation rate between HD and PD will be assessed. However, all patients will be followed to the end of the study to assess the primary endpoint which is all-cause mortality.
- Cause of Death [ Time Frame: 2-5 yrs. ]Cause of deaths due to acute myocardial infarction (AMI), congestive heart failure (CHF), infection (except peritonitis), peritonitis, malnutrition, stroke, cardiovascular and non-cardiovascular causes, etc., will be monitored for HD and PD patients
- Change in Erythropoiesis-stimulating agent (ESA) [ Time Frame: 2-5 yrs. ]Dose changes in ESA dose will affect patient's status for anemia control, and will be monitored for HD and PD patients.
- Change in blood pressure, hemoglobin, and S-phosphate [ Time Frame: 2-5 yrs. ]Blood pressure, hemoglobin, and S-phosphate will be monitored for HD and PD patients.
- Subjective Global Assessment for Nutritional Status [ Time Frame: 2-5 yrs. ]Subjective Global Assessment (SGA) is a technique to assess a patient's nutritional status. The SGA will be measured by one dedicated, trained physician per site at visit 1, every 24 weeks (±14 days) from visit 1 to visit 23, and at the end-of-study visit.
- Systemic inflammation as assessed by hs-CRP [ Time Frame: 2-5 yrs. ]Scores of systemic inflammation will be assessed using high-sensitivity C reactive protein (hs-CRP). Hs-CRP will be assessed at visits 1, 4-23, and at the end-of-study visit.
- Quality of Life Quality of life (QOL) [ Time Frame: 2-5 yrs. ]Quality of Life Quality of life (QOL) will be assessed using the EQ-5D-3L (European Quality of Life - 5 Dimensions - 3L translation), the KDQoL-SF (Kidney Disease Quality of Life Short Form) questionnaires, and the Karnofsky Index. QOL will be assessed at visit 1, every 24 weeks (±14 days) from visit 1 to visit 23, and at the end-of-study visit.
To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.
Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT01413074
|The First Affiliated Hospital , Sun Yet-Sen University|
|Guangzhou, Guangdong, China, 510080|
|Shanghai Changzheng Hospital|
|Shanghai, Shanghai, China, 200003|
|Ruijin Hospital,Shanghai Jiaotong University , School of Medicine|
|Shanghai, Shanghai, China, 200025|
|Huashan Hospital ,Fudan University|
|Shanghai, Shanghai, China, 200040|
|Renji Hospital , Shanghai Jiaotong University , School of Medicine|
|Shanghai, Shanghai, China|
|The First Affiliated Hospital , Zhejiang University, School of Medicine|
|Hangzhou, Zhejiang, China, 310003|
|Hangzhou Hospital of Tranditional Chinese Medicine|
|Hangzhou, Zhejiang, China, 310007|
|Principal Investigator:||Quian Jia-Qi, Prof.||Shanghai Jiao Tong University School of Medicine|
|Principal Investigator:||Yu Xue-qing, Prof.||First Affiliated Hospital, Sun Yat-Sen University|