End Stage Renal DiseaseNCT01413074
Survival on Peritoneal Dialysis (PD) Versus Hemodialysis (HD) in China
A study testing Peritoneal Dialysis treatment and Hemodialysis treatment in people with End Stage Renal Disease, run by Vantive Health LLC at 7 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- End Stage Renal Disease
- What is being tested?
- Peritoneal Dialysis treatment and Hemodialysis treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 416 participants
- Where
- 7 sitesChina
- Study dates
- Jun 2011to Dec 2013
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
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- 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.
- Subjects who have normal liver function, as judged by the investigator.
- 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.
Who cannot join
- 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.
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- 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.
- Subjects who are unwilling or expected to be unable to fully comply with the visits and assessments required by the protocol.
- Subjects who have previously been randomized in this study.
- 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.
- Subjects who have a serious or acute condition that, as judged by the investigator, would preclude participation in the study.
- Subjects who have a malignancy requiring chemotherapy or radiation therapy.
- Subjects undergoing temporary dialysis treatment between the screening visit and Day 1 that is expected to exceed 6 weeks in duration.
- Subjects who have a life expectancy of less than 48 weeks.
Trial locations and contacts
7 sites in 1 country.
7 sites in 1 country
China7 sites
The First Affiliated Hospital , Sun Yet-Sen University
Guangzhou, Guangdong, 510080
The First Affiliated Hospital , Zhejiang University, School of Medicine
Hangzhou, Zhejiang, 310003
Hangzhou Hospital of Tranditional Chinese Medicine
Hangzhou, Zhejiang, 310007
Shanghai Changzheng Hospital
Shanghai, Shanghai Municipality, 200003
Ruijin Hospital,Shanghai Jiaotong University , School of Medicine
Shanghai, Shanghai Municipality, 200025
Huashan Hospital ,Fudan University
Shanghai, Shanghai Municipality, 200040
Renji Hospital , Shanghai Jiaotong University , School of Medicine
Shanghai, Shanghai Municipality
About this study
Official title: A Prospective, Randomized, Multicenter, Open-Label, Interventional Study Comparing Survival in Subjects Receiving Peritoneal Dialysis vs Hemodialysis in China
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:
Read more
- 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.
- Conditions
- End Stage Renal Disease
- Being tested
- Peritoneal Dialysis treatment, Hemodialysis treatment
- Keywords
- End Stage Renal Disease, ESRD, Peritoneal Dialysis, PD, Hemodialysis, HD
- Medical subject headings
- Kidney Failure, Chronic
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Peritoneal Dialysis treatmentOther
PD treatment
Hemodialysis treatmentOther
HD treatment
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients receiving HD treatment | Active comparator | no investigational drug involved. Only oberseve therapy treatment Receives: Other: Hemodialysis treatment |
| ESRD patients receiving PD treatment | Experimental | no investigational drug involved. Only oberseve therapy treatment Receives: Other: Peritoneal Dialysis treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment
Measured: 2-5 yrs.
Secondary outcomes (13)
Assess and compare technique failure
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.
Measured: 2-5 yrs.
Residual Renal Function (RRF)
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.
Measured: 2-5 yrs
Dialysis Adequacy
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.
Measured: 2-5 yrs.
Co-morbidity Assessment
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.
Measured: 2-5 yrs.
Occurrence of Bacterial and Other Infections Infection rates
Occurrence of bacterial and other infections infection rates, especially regarding exit sites and peritoneal, will be monitored for HD and PD patients.
Measured: 2-5 yrs.
Hospitalization
Hospitalization rates and duration for each underlying reason will be monitored for HD and PD patients.
Measured: 2-5 yrs.
Transplantation Rate
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.
Measured: 2-5 yrs.
Cause of Death
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
Measured: 2-5 yrs.
Change in Erythropoiesis-stimulating agent (ESA)
Dose changes in ESA dose will affect patient's status for anemia control, and will be monitored for HD and PD patients.
Measured: 2-5 yrs.
Change in blood pressure, hemoglobin, and S-phosphate
Blood pressure, hemoglobin, and S-phosphate will be monitored for HD and PD patients.
Measured: 2-5 yrs.
Subjective Global Assessment for Nutritional Status
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.
Measured: 2-5 yrs.
Systemic inflammation as assessed by hs-CRP
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.
Measured: 2-5 yrs.
Quality of Life Quality of life (QOL)
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.
Measured: 2-5 yrs.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted10 Aug 2011 (estimated)
- Study startJun 2011
- Primary completionDec 2013
- Study completionDec 2013
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 416 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
- Investigators
- Quian Jia-Qi, Prof., Principal investigator, Shanghai Jiao Tong University School of MedicineYu Xue-qing, Prof., Principal investigator, First Affiliated Hospital, Sun Yat-Sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01413074
- Sponsor's protocol ID
- CHN-RENAL-CTPIV-2010-106
- Status last verified
- Feb 2026
- First submitted
- 16 Jun 2011
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
PubMed 38899545Quinn RR, Lam NN. Home Dialysis in North America: The Current State. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1351-1358. doi: 10.2215/CJN.0000000000000273. Epub 2023 Jul 31.
PubMed 37523194
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective, Randomized, Multicenter, Open-Label, Interventional Study Comparing Survival in Subjects Receiving Peritoneal Dialysis vs Hemodialysis in China
- ClinicalTrials.gov ID
- NCT01413074
- Acronym / sponsor ID
- CHN-RENAL-CTPIV-2010-106
- Conditions
- End Stage Renal Disease
- Keywords
- End Stage Renal Disease, ESRD, Peritoneal Dialysis, PD, Hemodialysis, HD
- Study type
- Interventional
- Recruitment status
- Terminated
- Enrolment
- 416 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- Jun 2011
- Primary completion
- Dec 2013 (actual)
- Study completion
- Dec 2013 (actual)
- First posted
- 10 Aug 2011 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| ESRD patients receiving HD treatment | Active comparator | Other: Hemodialysis treatmentno investigational drug involved. Only oberseve therapy treatment |
| ESRD patients receiving PD treatment | Experimental | Other: Peritoneal Dialysis treatmentno investigational drug involved. Only oberseve therapy treatment |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- 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.
Key exclusion criteria (17 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Peritoneal Dialysis treatmentPD treatment | Other | ESRD patients receiving PD treatment |
| Hemodialysis treatmentHD treatment | Other | ESRD patients receiving HD treatment |
Primary outcome
Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment
Time frame: 2-5 yrs.
13 secondary outcomes
Assess and compare technique failure
Time frame: 2-5 yrs.
Residual Renal Function (RRF)
Time frame: 2-5 yrs
Dialysis Adequacy
Time frame: 2-5 yrs.
Co-morbidity Assessment
Time frame: 2-5 yrs.
Occurrence of Bacterial and Other Infections Infection rates
Time frame: 2-5 yrs.
Hospitalization
Time frame: 2-5 yrs.
Transplantation Rate
Time frame: 2-5 yrs.
Cause of Death
Time frame: 2-5 yrs.
Change in Erythropoiesis-stimulating agent (ESA)
Time frame: 2-5 yrs.
Change in blood pressure, hemoglobin, and S-phosphate
Time frame: 2-5 yrs.
Subjective Global Assessment for Nutritional Status
Time frame: 2-5 yrs.
Systemic inflammation as assessed by hs-CRP
Time frame: 2-5 yrs.
Quality of Life Quality of life (QOL)
Time frame: 2-5 yrs.
Results and safety
The study was stopped early. Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 17 Feb 2026.
- Derived from this study: PubMed 38899545Ethier I, Hayat A, Pei J, Hawley CM, Johnson DW, Francis RS, Wong G, Craig JC, Viecelli AK, Htay H, Ng S, Leibowitz S, Cho Y. Peritoneal dialysis versus haemodialysis for people commencing dialysis. Cochrane Database Syst Rev. 2024 Jun 20;6(6):CD013800. doi: 10.1002/14651858.CD013800.pub2.
- Derived from this study: PubMed 37523194Quinn RR, Lam NN. Home Dialysis in North America: The Current State. Clin J Am Soc Nephrol. 2023 Oct 1;18(10):1351-1358. doi: 10.2215/CJN.0000000000000273. Epub 2023 Jul 31.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Quian Jia-Qi, Prof. principal investigator
Shanghai Jiao Tong University School of Medicine
Yu Xue-qing, Prof. principal investigator
First Affiliated Hospital, Sun Yat-Sen University
7 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Peritoneal Dialysis treatment and Hemodialysis treatment in people with End Stage Renal Disease, run by Vantive Health LLC at 7 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 10 inclusion and 17 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: stopped early, as of the sponsor's last update on 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 7 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study was stopped early. Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Assess and compare survival or all cause mortality in subjects undergoing PD or HD treatment (time frame: 2-5 yrs.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT01413074, which also lists 2 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 17 Feb 2026.