Kidney Failure,ChronicPhase 4SEEDNCT01779557
Safety and Effectiveness Evaluation of Two Kinds of Peritoneal Dialysate
A Phase 4 study testing Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate in people with Kidney Failure,Chronic, run by Chinese PLA General Hospital at 1 site in China.
Trial summary
This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Kidney Failure,Chronic
- What is being tested?
- Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 750 participants
- Where
- 1 siteChina
- Study dates
- Feb 2013to Sep 2021
- 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
- Age ≥18, male or female
- Patients with end stage renal diseases
- Dialysis mode: CAPD
- Dialysis duration:≥30 days and ≤6 months
- Be capable of implementing home dialysis
- Diabetic nephropathy, 3ml/min≤ residual renal GFR ≤15ml/min; other renal diseases, 3ml/min≤ residual renal GFR ≤10ml/min
- Sign the written informed consent
Who cannot join
- Acute renal failure
- Planing to receive kidney transplantation in 2 years
- Hemodialysis
- Exit site infection or tunnel infection
- Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid;
- Anti-HIV positive
Show all 14Show fewer
- Allergic to components of dialysate
- Active, residual malignant tumor, or systemic infection, liver cirrhosis, severe congestive heart failure, anemia（Hb<80g/L）,malnutrition（Serum Alb<28g/L）,refractory hypertension
- Identified peritoneal high transportation by peritoneal equilibration test (PET)
- Extreme body shape (height> 185cm or height <145cm), obesity (BMI ≥ 33kg/m2)
- Poor compliance
- Pregnant or lactating, women of childbearing age do not agree to use effective contraceptive measures during the trial
- Has a history of alcoholism and drug abuse (defined as illegal drugs)
- Any circumstances when patients are believed unsuitable for this trial
Trial locations and contacts
1 site in 1 country.
About this study
Official title: The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
This study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.
Read the detailed description
This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.
- Conditions
- Kidney Failure,Chronic
- Being tested
- Huaren Peritoneal Dialysate, Baxter Peritoneal Dialysate
- Keywords
- CAPD, efficacy, safety, survival rate
- 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.
Huaren Peritoneal DialysateDrug
Huaren Peritoneal dialysate CAPD 3-5 times/d
Baxter Peritoneal DialysateDrug
Baxter Peritoneal dialysate CAPD 3-5 times/d
| Study group | Role | What they receive |
|---|---|---|
| Huaren peritoneal dialysate | Experimental | Huaren Peritoneal dialysate CAPD 3-5 times/d Receives: Drug: Huaren Peritoneal Dialysate |
| Baxter Peritoneal Dialysate | Active comparator | Baxter Peritoneal dialysate CAPD 3-5 times/d Receives: Drug: Baxter Peritoneal Dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
survival rate
Measured: 1,2,3,4,5 years
Secondary outcomes (8)
PD technique survival rate
Measured: 1,2,3,4,5 years
estimated glomerular filtration rate decline
Measured: 1,2,3,4,5 years
nutritional status
Measured: 1,2,3,4,5 years
quality of life(SF-36)
Measured: 1,2,3,4,5 years
cardiovascular events
Measured: 1,2,3,4,5 years
increments of dialysis dose
Measured: 1,2,3,4,5 years
medical costs
Measured: 1,2,3,4,5 years
dropout rate
Measured: 1,2,3,4,5 years
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted30 Jan 2013 (estimated)
- Study startFeb 2013
- Primary completionOct 2019
- Study completionSep 2021
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 Kidney Failure,ChronicStudies of the same condition, open and under way.
- More trials run by Chinese PLA General HospitalThe sponsor's other registered studies.
- 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
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 750 participants (actual)
Sponsor and investigators
- Lead sponsor
- Chinese PLA General Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Chen Xiangmei, Chinese PLA General Hospital
- Investigators
- CHEN Xiangmei, yes, Study director, Chinese PLA General Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01779557
- Sponsor's protocol ID
- HR-PD-2012
- Other IDs
- ChiCTR-TRC-13003001
- Acronym
- SEED
- Status last verified
- Mar 2022
- First submitted
- 29 Jan 2013
- Last updated
- 10 Mar 2022
- Results posted
- No
- Data monitoring committee
- Yes
Publications
Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1.
PubMed 26715594
Study at a glance
From the registry record, last updated by the sponsor on 10 Mar 2022. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Prospective, Randomized, Parallel, Controlled, Multi-center Clinical Study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate
- ClinicalTrials.gov ID
- NCT01779557
- Acronym / sponsor ID
- SEED / HR-PD-2012
- Conditions
- Kidney Failure,Chronic
- Keywords
- CAPD, efficacy, safety, survival rate
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 750 participants (actual)
- Lead sponsor
- Chinese PLA General HospitalUniversity, hospital or other
- Study start
- Feb 2013 (actual)
- Primary completion
- Oct 2019 (actual)
- Study completion
- Sep 2021 (actual)
- First posted
- 30 Jan 2013 (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 study is to evaluate the effectiveness and safety of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate, investigate the proper dialysis dose for Chinese CAPD patients.
Detailed description
This study is a prospective, randomized, parallel, controlled, multi-center clinical study of Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate.It aims to investigate the proper dialysis dose for Chinese CAPD patients.At the same time,it can evaluate the effectiveness and safety of Chinese product Huaren Peritoneal Dialysate and peritoneal dialysis product Baxter Peritoneal Dialysate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Huaren peritoneal dialysate | Experimental | Drug: Huaren Peritoneal DialysateHuaren Peritoneal dialysate CAPD 3-5 times/d |
| Baxter Peritoneal Dialysate | Active comparator | Drug: Baxter Peritoneal DialysateBaxter Peritoneal dialysate CAPD 3-5 times/d |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Age ≥18, male or female
- Patients with end stage renal diseases
- Dialysis mode: CAPD
- Dialysis duration:≥30 days and ≤6 months
- Be capable of implementing home dialysis
Key exclusion criteria (14 listed)
- Acute renal failure
- Planing to receive kidney transplantation in 2 years
- Hemodialysis
- Exit site infection or tunnel infection
- Presenting 2/3 of the following: a. abdominal pain, turbid ascites, with or without fever; b. drainage fluid WBC>100×106/L, neutrophil ratio>50%; c.culture positive/ Gram stain positive in drainage fluid;
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 |
|---|---|---|
| Huaren Peritoneal DialysateHuaren Peritoneal dialysate CAPD 3-5 times/d | Drug | Huaren peritoneal dialysate |
| Baxter Peritoneal DialysateBaxter Peritoneal dialysate CAPD 3-5 times/d | Drug | Baxter Peritoneal Dialysate |
Primary outcome
survival rate
Time frame: 1,2,3,4,5 years
8 secondary outcomes
PD technique survival rate
Time frame: 1,2,3,4,5 years
estimated glomerular filtration rate decline
Time frame: 1,2,3,4,5 years
nutritional status
Time frame: 1,2,3,4,5 years
quality of life(SF-36)
Time frame: 1,2,3,4,5 years
cardiovascular events
Time frame: 1,2,3,4,5 years
increments of dialysis dose
Time frame: 1,2,3,4,5 years
medical costs
Time frame: 1,2,3,4,5 years
dropout rate
Time frame: 1,2,3,4,5 years
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 10 Mar 2022.
- Derived from this study: PubMed 26715594Zhou J, Cao X, Lin H, Ni Z, He Y, Chen M, Zheng H, Chen X. Safety and effectiveness evaluation of a domestic peritoneal dialysis fluid packed in non-PVC bags: study protocol for a randomized controlled trial. Trials. 2015 Dec 29;16:592. doi: 10.1186/s13063-015-1131-1.
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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.
CHEN Xiangmei, yes study director
Chinese PLA General Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Huaren Peritoneal Dialysate and Baxter Peritoneal Dialysate in people with Kidney Failure,Chronic, run by Chinese PLA General Hospital at 1 site 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 7 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 10 Mar 2022. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
survival rate (time frame: 1,2,3,4,5 years). 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 NCT01779557, 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 10 Mar 2022.