Clinical trial NCT01413074: Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
Official title: A Prospective, Randomized, Multicenter, Open-Label, Interventional Study Comparing Survival in Subjects Receiving Peritoneal Dialysis vs Hemodialysis in China
Study type: INTERVENTIONAL
Overall status: TERMINATED
Phase: PHASE4
Conditions: End Stage Renal Disease
Keywords: End Stage Renal Disease
ESRD
Peritoneal Dialysis
PD
Hemodialysis
HD
Lead sponsor: Baxter Healthcare Corporation
Sponsor class: INDUSTRY
First posted: 2011-08-10
Enrollment: 416
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.


Eligibility criteria: Inclusion Criteria:

1. Subjects of either sex, aged 18 years or older at time of randomization.
2. 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.
3. 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.
4. Subjects, or their legal representative, who, as judged by the investigator, are capable of being trained for home-based PD.
5. Subjects, or their legal representative, who are able to understand and voluntarily sign an ICF.
6. Subjects who are able to adhere to the study visit schedule and other protocol requirements.
7. Subjects who are able to regularly visit a HD center for HD therapy (≥ 3 times per week).
8. Subjects who, as judged by the investigator, are expected to remain on dialysis for at least 48 weeks.
9. Subjects who have normal liver function, as judged by the investigator.
10. Female subjects of childbearing potential who have a negative serum or urine pregnancy test at screening. Sexually active women of childbearing potential must agree to use adequate contraceptive methods, as judged by the investigator, while in the study.

Exclusion Criteria:

1. Subjects who are HIV positive.
2. 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.
3. 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.
4. Subjects who have dementia or a mental status that would significantly affect the subject's understanding of the Informed Consent Form (ICF).
5. Subjects who are pregnant, intend to become pregnant during the study period, or are breast-feeding.
6. 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.
7. Subjects who have previously received renal transplantation and are still being prescribed immunosuppressive therapy.
8. 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.
9. Subjects who are unwilling or expected to be unable to fully comply with the visits and assessments required by the protocol.
10. Subjects who have previously been randomized in this study.
11. Subjects who are not eligible for either PD or HD, as judged by the investigator, due to:

    PD: documented extensive intra-peritoneal adhesions or other condition contraindicated for PD.

    HD: severe cardiac instability or other condition contraindicated for HD.
12. Subjects who have a serious or acute condition that, as judged by the investigator, would preclude participation in the study.
13. Subjects who have a malignancy requiring chemotherapy or radiation therapy.
14. Subjects undergoing temporary dialysis treatment between the screening visit and Day 1 that is expected to exceed 6 weeks in duration.
15. Subjects who have a life expectancy of less than 48 weeks.

Primary outcomes:
measure: Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment
timeFrame: 2-5 yrs.
Secondary outcomes:
measure: Assess and compare technique failure
timeFrame: 2-5 yrs.
measure: Residual Renal Function (RRF)
timeFrame: 2-5 yrs
measure: Dialysis Adequacy
timeFrame: 2-5 yrs.
measure: Co-morbidity Assessment
timeFrame: 2-5 yrs.
measure: Occurrence of Bacterial and Other Infections Infection rates
timeFrame: 2-5 yrs.
measure: Hospitalization
timeFrame: 2-5 yrs.
measure: Transplantation Rate
timeFrame: 2-5 yrs.
measure: Cause of Death
timeFrame: 2-5 yrs.
measure: Change in Erythropoiesis-stimulating agent (ESA)
timeFrame: 2-5 yrs.
measure: Change in blood pressure, hemoglobin, and S-phosphate
timeFrame: 2-5 yrs.
measure: Subjective Global Assessment for Nutritional Status
timeFrame: 2-5 yrs.
measure: Systemic inflammation as assessed by hs-CRP
timeFrame: 2-5 yrs.
measure: Quality of Life Quality of life (QOL)
timeFrame: 2-5 yrs.
Other outcomes:
Locations:
city: Guangzhou
country: China
facility: The First Affiliated Hospital , Sun Yet-Sen University
state: Guangdong
city: Shanghai
country: China
facility: Shanghai Changzheng Hospital
state: Shanghai
city: Shanghai
country: China
facility: Ruijin Hospital,Shanghai Jiaotong University , School of Medicine
state: Shanghai
city: Shanghai
country: China
facility: Huashan Hospital ,Fudan University
state: Shanghai
city: Shanghai
country: China
facility: Renji Hospital , Shanghai Jiaotong University , School of Medicine
state: Shanghai
city: Hangzhou
country: China
facility: The First Affiliated Hospital , Zhejiang University, School of Medicine
state: Zhejiang
city: Hangzhou
country: China
facility: Hangzhou Hospital of Tranditional Chinese Medicine
state: Zhejiang
Study officials:
affiliation: Shanghai Jiao Tong University School of Medicine
name: Quian Jia-Qi, Prof.
role: PRINCIPAL_INVESTIGATOR
affiliation: First Affiliated Hospital, Sun Yat-Sen University
name: Yu Xue-qing, Prof.
role: PRINCIPAL_INVESTIGATOR
References: