End Stage Renal DiseasePhase 4NCT02378350
Quality of Life on Peritoneal Dialysis Versus Hemodialysis in China
A Phase 4 study testing Hemodialysis treatment (no specific device is defined) and Peritoneal Dialysis treatment (no specific drug is defined) in people with End Stage Renal Disease, run by Vantive Health LLC at 21 sites in China.
Trial summary
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment. Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD)… 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?
- Hemodialysis treatment (no specific device is defined) and Peritoneal Dialysis treatment (no specific drug is defined)
- Type of treatment
- Medical device
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 668 participants
- Where
- 21 sitesChina
- Study dates
- 26 Mar 2014to 18 Sep 2017
- Phase
- Phase 4
- 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 or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
- Male or female subjects aged 18 years or older at the time of randomization
- Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF
- Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF
- Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
- Subjects who are able to adhere to the study visit schedule and other protocol requirements
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- Subjects who are able to come to HD clinics as required by the protocol
- 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 must have 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 maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤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 an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study
- Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening
- Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
- Subjects who are currently using any investigational drug
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- Subjects who are currently enrolled in other clinical studies
- Subjects who are unwilling or unable to fully comply with the visits and assessments required by the protocol
- Subjects who are not eligible for either PD or HD, as judged by the Investigator, due to:
- Peritoneal dialysis: documented extensive intra-peritoneal adhesions or other conditions in which PD is contraindicated
- Hemodialysis: severe cardiac instability or other conditions in which HD is contraindicated
- Subjects who have a malignancy requiring chemotherapy or radiation therapy
- Subjects undergoing temporary dialysis treatment between the Screening visit and Day 1 visit that is expected to exceed 6 weeks in duration
- Subjects who have a life expectancy of < 48 weeks
Trial locations and contacts
21 sites in 1 country.
21 sites in 1 country
China21 sites
The Third Xiangya Hospital of Central South University
Changsha, Hunan
Sichuan Provincial People's Hospital
Chengdu, Sichuan
First Hospital of Affiliated of Dalian Medical University
Dalian, Liaoning
The First Affiliated Hospital of Fujian Medical University
Fuzhou, Fujian
The First Affiliated Hospital , Sun Yet-Sen University
Guangzhou, Guangdong, 510080
Guangzhou Panyu Central Hospital
Guangzhou, Guangdong
The Third Hospital of Sun Yat-Sen University
Guangzhou, Guangdong
Guizhou Province People's Hospital
Guiyang, Guizhou
The Second Affiliated Hospital of Harbin Medical University
Harbin, Heilongjiang
Lanzhou University Second Hospital
Lanzhou, Gansu
Jiangxi province people's hospital
Nanchang, Jiangxi
Nanchang First Affiliated Hospital
Nanchang, Jiangxi
Renji Hospital , Shanghai Jiaotong University , School of Medicine
Shanghai, Shanghai Municipality, 200127
Shanghai 455 Hospital
Shanghai, Shanghai Municipality
Shanghai Tenth People's Hospital
Shanghai, Shanghai Municipality
Shanghai Xinhua Hospital
Shanghai, Shanghai Municipality
The 2nd Shenzhen Municipal People's Hospital
Shenzhen, Guangdong
The Second Affiliated Hospital of Soochow University
Suzhou, Jiangsu
The First Affiliated Hospital of Tianjin University of TCM
Tianjin, Tianjin Municipality
Traditional Chinese Medicine Hospital of Wuhan
Wuhan, Hubei
General Hospital of Ningxia Medical University
Yingchuan, Ningxia
About this study
Official title: A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire domain of burden of kidney disease.
Read more
Secondary Objectives: The secondary objectives are to observe and summarize the following parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items, which will be compared between the 2 treatment groups:
- Mortality rates
- Switch (PD to HD or HD to PD)
- Transplantation rate
- Cause of death
- Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the volume of distribution of urea [Kt/V urea] to determine the proportion of subjects meeting standards of care for dialysis adequacy).
- 24-hour urine volume
- Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values within the target range
- Change in serum albumin
- Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
- Conditions
- End Stage Renal Disease
- Being tested
- Hemodialysis treatment (no specific device is defined), Peritoneal Dialysis treatment (no specific drug is defined)
- 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.
Hemodialysis treatment (no specific device is defined)Device
Peritoneal Dialysis treatment (no specific drug is defined)Drug
| Study group | Role | What they receive |
|---|---|---|
| ESRD patients receiving HD treatment | Active comparator | no investigational drug involved. Only observe therapy treatment Receives: Device: Hemodialysis treatment (no specific device is defined) |
| ESRD patients receiving PD treatment | Experimental | no investigational drug involved. Only observe therapy treatment Receives: Drug: Peritoneal Dialysis treatment (no specific drug is defined) |
What is being measured
The primary outcome is the main question the study is designed to answer.
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
Measured: 1 year
Secondary outcomes (10)
Mortality rates
Measured: 1 year
Switch (PD to HD or HD to PD)
Measured: 1 year
Transplantation rate
Measured: 1 year
Cause of death
Measured: 1 year
Dialysis adequacy
Measured: 1 year
24-hour urine volume
Measured: 1 year
Change in hemoglobin
Measured: 1 year
Change in serum albumin
Measured: 1 year
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Measured: 1 year
Change in S-phosphate levels
Measured: 1 year
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted4 Mar 2015 (estimated)
- Study start26 Mar 2014
- Primary completion18 Sep 2017
- Study completion18 Sep 2017
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 668 participants (actual)
Sponsor and investigators
- Lead sponsor
- Vantive Health LLC
- Sponsor type
- Industry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02378350
- Sponsor's protocol ID
- 8339-001
- Status last verified
- Mar 2025
- First submitted
- 10 Feb 2015
- Last updated
- 13 Mar 2025
- 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 38899545
Study at a glance
From the registry record, last updated by the sponsor on 13 Mar 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Open-Label Study of Quality of Life in Peritoneal Dialysis and Conventional In-Center Hemodialysis (ChinaQ Study)
- ClinicalTrials.gov ID
- NCT02378350
- Acronym / sponsor ID
- 8339-001
- Conditions
- End Stage Renal Disease
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 668 participants (actual)
- Lead sponsor
- Vantive Health LLCIndustry (pharma, biotech, devices)
- Collaborators
- Baxter Healthcare Corporation
- Study start
- 26 Mar 2014 (actual)
- Primary completion
- 18 Sep 2017 (actual)
- Study completion
- 18 Sep 2017 (actual)
- First posted
- 4 Mar 2015 (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.
This is a multicenter, randomized, open-label study to compare QoL in subjects with end-stage renal disease (ESRD) requiring PD or conventional in-center HD treatment.
Primary Objective: The primary objective is to demonstrate non-inferiority of peritoneal dialysis (PD) treatment as compared to hemodialysis (HD) treatment after approximately 1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire domain of burden of kidney disease.
Secondary Objectives: The secondary objectives are to observe and summarize the following parameters in subjects receiving PD or HD treatment except for the remaining domains of QoL instrument KDQoL-SF™ (version 1.3) and the 2 individual QoL items scored as single items, which will be compared between the 2 treatment groups:
- Mortality rates
- Switch (PD to HD or HD to PD)
- Transplantation rate
- Cause of death
- Dialysis adequacy (ie, urea clearance time normalized by total body water, which is the volume of distribution of urea [Kt/V urea] to determine the proportion of subjects meeting standards of care for dialysis adequacy).
- 24-hour urine volume
- Change in hemoglobin and S-phosphate levels, and the percentages of subjects with values within the target range
- Change in serum albumin
- Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
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 | Device: Hemodialysis treatment (no specific device is defined)no investigational drug involved. Only observe therapy treatment |
| ESRD patients receiving PD treatment | Experimental | Drug: Peritoneal Dialysis treatment (no specific drug is defined)no investigational drug involved. Only observe 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 or their legal representative who are able to understand and have voluntarily signed the informed consent form (ICF)
- Male or female subjects aged 18 years or older at the time of randomization
- Subjects diagnosed with ESRD (ie, an estimated glomerular filtration rate ≤15 mL/min/1.73 m2 body surface area) and who the Investigator anticipates will require maintenance dialysis therapy within 10 weeks after signing the ICF
- Subjects who, as judged by the Investigator, are able to comprehend the standardized, predialysis education program and have completed this education prior to signing the ICF
- Subjects or their legal representative who, as judged by the Investigator, are capable of being trained for home-based PD
Key exclusion criteria (14 listed)
- Subjects who are HIV positive
- Subjects who have already received maintenance dialysis. Subjects are not excluded if a functional dialysis access is present ≤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 an active infection or other condition that the Investigator determines may jeopardize their ability to receive either modality of dialysis treatment or would preclude participation in the study
- Subjects who report a history of illicit drug use or a regular or daily alcohol consumption of ≥4 alcoholic drinks per day in the 2 years before Screening
- Subjects who have previously received renal transplantation and are currently prescribed immunosuppressive therapy
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 |
|---|---|---|
| Hemodialysis treatment (no specific device is defined) | Device | ESRD patients receiving HD treatment |
| Peritoneal Dialysis treatment (no specific drug is defined) | Drug | ESRD patients receiving PD treatment |
Primary outcome
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire
Time frame: 1 year
10 secondary outcomes
Mortality rates
Time frame: 1 year
Switch (PD to HD or HD to PD)
Time frame: 1 year
Transplantation rate
Time frame: 1 year
Cause of death
Time frame: 1 year
Dialysis adequacy
Time frame: 1 year
24-hour urine volume
Time frame: 1 year
Change in hemoglobin
Time frame: 1 year
Change in serum albumin
Time frame: 1 year
Frequency of adverse events (AEs) and serious AEs (SAEs), including abnormal laboratory test findings with clinical significance
Time frame: 1 year
Change in S-phosphate levels
Time frame: 1 year
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Mar 2025.
- 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.
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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.
The record lists no contact. Use the official record to reach the sponsor.
21 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Hemodialysis treatment (no specific device is defined) and Peritoneal Dialysis treatment (no specific drug is defined) in people with End Stage Renal Disease, run by Vantive Health LLC at 21 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 14 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: finished, as of the sponsor's last update on 13 Mar 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 21 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.
What does this phase mean?
Phase 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
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?
1 year of therapy using the Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire (time frame: 1 year). 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 NCT02378350, which also lists 1 linked publication.
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 13 Mar 2025.