Disorders Associated With Peritoneal DialysisNCT02393261
A Controlled and Multi-Center Study of 2500ml Huaren Peritoneal Dialysate
A study testing 2500ml Huaren peritoneal dialysate and 2000ml peritoneal dialysate in people with Disorders Associated With Peritoneal Dialysis, run by Sun Yat-sen University at 1 site in China.
Trial summary
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Disorders Associated With Peritoneal Dialysis
- What is being tested?
- 2500ml Huaren peritoneal dialysate and 2000ml peritoneal dialysate
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 300 participants
- Where
- 1 siteChina
- Study dates
- Jan 2015to Jun 2015
- 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 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- The duration of PD is more than 1 month.
- The age is range from 18 to 80 years old.
- The patient can be treated with regular PD in home.
- The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
- The patient can be visited regularly.
- The patient must be freely given informed consent
Who cannot join
- Peritonitis was happened within 1 month
- The KT/V<1.7
- Infections in the exit or tunnel
- With tumors.
- With low transport of peritoneum.
- With mental and behavior disorders.
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- With acute renal failure
- Hemodialysis meanwhile
- With heart failure( NYHA III-IV ) or cardio- cerebrovascular events
- Attending other clinical trails
- Refused to give informed consent Exit criteria
- （1）Stop PD for more than 10 days （2）The patient demand to quit from the RCT （3）With serious adverse events.
Trial locations and contacts
1 site in 1 country.
China1 site, 1 recruiting
- Recruiting
Department of Nephrology, 6th Affiliated Hospital, Sun Yat-Sen University
Guangzhou, Guangdong, 510655
Zongpei Jiang, M.D. & Ph.D., 8620-38379727, jx.home@medmail.com.cn
Zongpei Jiang, M.D. & Ph.D.
About this study
Official title: Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
This prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.
Read the detailed description
Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.
- Being tested
- 2500ml Huaren peritoneal dialysate, 2000ml peritoneal dialysate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2500ml Huaren peritoneal dialysateOther
use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night
2000ml peritoneal dialysateOther
use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night
| Study group | Role | What they receive |
|---|---|---|
| A 2500mlGroup | Experimental | use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night Receives: Other: 2500ml Huaren peritoneal dialysate |
| B 2000mlGroup | Active comparator | use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night Receives: Other: 2000ml peritoneal dialysate |
What is being measured
The primary outcome is the main question the study is designed to answer.
Adequacy of dialysis (kt/v)
kt/v
Measured: up to 8 weeks
Secondary outcomes (2)
Residual kidney function (Residual kidney kt/v)
Residual kidney kt/v
Measured: up to 6 months
Peritoneal function (Peritoneal equilibration test)
Peritoneal equilibration test
Measured: up to 6 months
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Mar 2015 (estimated)
- Study startJan 2015
- Primary completionJun 2015 (estimated)
- Study completionJun 2015 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Disorders Associated With Peritoneal DialysisStudies of the same condition, open and under way.
- More trials run by Sun Yat-sen UniversityThe 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 N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 300 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Sun Yat-sen University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Yanhong Deng, Sun Yat-sen University
- Investigators
- Zongpei Jiang, M.D. & Ph.D., Principal investigator, Sixth Affiliated Hospital, Sun Yat-sen University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT02393261
- Sponsor's protocol ID
- Usix -2500PD-001
- Status last verified
- Mar 2015
- First submitted
- 9 Mar 2015
- Last updated
- 19 Mar 2015
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Mar 2015. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Validity and Security of 2500ml Huaren Peritoneal Dialysate: A Prospective, Randomized, Controlled, Multi-Center Clinical Trial
- ClinicalTrials.gov ID
- NCT02393261
- Acronym / sponsor ID
- Usix -2500PD-001
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 300 participants (estimated)
- Lead sponsor
- Sun Yat-sen UniversityUniversity, hospital or other
- Study start
- Jan 2015
- Primary completion
- Jun 2015 (estimated)
- Study completion
- Jun 2015 (estimated)
- First posted
- 19 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 prospective, randomized, controlled, multi-center clinical trial will evaluate the validity and security of 2500ml Huaren Peritoneal Dialysate compared with normal 2000ml peritoneal dialysate.
Detailed description
Peritoneal dialysis (PD) is one of important way of renal replacement treatment worldwide. In China, about 40,000 patients suffered from end stage renal disease treated with PD, and most of them used imported dialysate, of which the price carried a great burden. Now, cheaper domestic dialysate is accessed to the ESRD patients in china, but the efficacy and safety of which are not fully clear. And according to researches from Hongkong, 6000ml of dialysate every day is able to. Thus, we presume 3 bags of 2500ml Huaren dialysate will satisfy the everyday need of an normal Asian. This will be a prospective, randomized, controlled, multi-center study. Patients in treatment group will use 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night, while those in control group will use 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night for 12 weeks. After followed-up for 12 weeks, the adequacy of PD, residual kidney function , peritoneum function and QOL of patients will be evaluated.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| A 2500mlGroup | Experimental | Other: 2500ml Huaren peritoneal dialysateuse 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night |
| B 2000mlGroup | Active comparator | Other: 2000ml peritoneal dialysateuse 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- The duration of PD is more than 1 month.
- The age is range from 18 to 80 years old.
- The patient can be treated with regular PD in home.
- The volume of peritoneal dialysate is from 8L to 10 L in 1 day.
- The patient can be visited regularly.
Key exclusion criteria (12 listed)
- Peritonitis was happened within 1 month
- The KT/V<1.7
- Infections in the exit or tunnel
- With tumors.
- With low transport of peritoneum.
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 |
|---|---|---|
| 2500ml Huaren peritoneal dialysateuse 2-3 bags of 2500ml Huaren dialysate in the daytime and keep 1 bag of 2500ml Huaren dialysate in the night | Other | A 2500mlGroup |
| 2000ml peritoneal dialysateuse 3-4 bags of normal 2000ml dialysate in the daytime and keep 1 bag of 2000ml dialysate in the night | Other | B 2000mlGroup |
Primary outcome
Adequacy of dialysis (kt/v)
Time frame: up to 8 weeks
kt/v
2 secondary outcomes
Residual kidney function (Residual kidney kt/v)
Time frame: up to 6 months
Peritoneal function (Peritoneal equilibration test)
Time frame: up to 6 months
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Mar 2015.
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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.
Zongpei Jiang, M.D. & Ph.D. principal investigator
Sixth Affiliated Hospital, Sun Yat-sen University
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing 2500ml Huaren peritoneal dialysate and 2000ml peritoneal dialysate in people with Disorders Associated With Peritoneal Dialysis, run by Sun Yat-sen University 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 6 inclusion and 12 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: status not confirmed, as of the sponsor's last update on 19 Mar 2015. 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.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Zongpei Jiang, M.D. & Ph.D. (8620-38379727, jx.home@medmail.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Adequacy of dialysis (kt/v) (time frame: up to 8 weeks). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Mar 2015.