Peritoneal Dialysis Solution Adverse ReactionPhase 4NCT05943470
The Difference Between Daily and Alternative Day Use of Icodextrin
A Phase 4 study testing Icodextrin Peritoneal Dialysis Solution in people with Peritoneal Dialysis Solution Adverse Reaction, run by RenJi Hospital.
Trial summary
Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis Solution Adverse Reaction
- What is being tested?
- Icodextrin Peritoneal Dialysis Solution
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 74 participants
- Where
- No sites listed yet
- Study dates
- 1 Aug 2023to 28 Dec 2024
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 1. End-stage renal failure
- 2. Patients with regular peritoneal dialysis in our center
- 3. 18-75 years old
- 4. Patients who currently use glucose dialysate for prolonged abdominals
- 5. Sign informed consent
Who cannot join
- 1. The expected survival time is less than 3 months
- 2. Known peritoneal dialysis tube dysfunction
- 3. Peritonitis occurred within one month
- 4. Known peritoneal effusion
- 5. Known allergy to icodextrin
About this study
Official title: The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis
Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients.
However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use.
Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.
Read the detailed description
- Patients who met the inclusion criteria will be enrolled in this study.
- Randomization.
- Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization.
- Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort.
- Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.
- Being tested
- Icodextrin Peritoneal Dialysis Solution
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Icodextrin Peritoneal Dialysis SolutionDrug
Also called Extraneal
alternative day use of icodextrin comparing with daily use of icodextrin
| Study group | Role | What they receive |
|---|---|---|
| daily | Active comparator | daily use of one exchange of icodextin as long dwell Receives: Drug: Icodextrin Peritoneal Dialysis Solution |
| alternative day | Experimental | alternative day use of one exchange of icodextin as long dwell Receives: Drug: Icodextrin Peritoneal Dialysis Solution |
What is being measured
The primary outcome is the main question the study is designed to answer.
ultrafiltration measured in ml
ultrafiltration volume for single icodextrin dwell
Measured: 2 weeks
Secondary outcomes (1)
daily treatment cost measured in Chinese Yuan
daily treatment cost
Measured: 2 weeks
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Jul 2023
- Study start1 Aug 2023 (estimated)
- Primary completion31 Dec 2023 (estimated)
- Study completion28 Dec 2024 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis Solution Adverse ReactionStudies of the same condition, open and under way.
- More trials run by RenJi 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
- Crossover
- Masking
- None (open label)
- Enrolment
- 74 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Zanzhe Yu, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05943470
- Sponsor's protocol ID
- LY2023-083
- Status last verified
- Jul 2023
- First submitted
- 11 Jun 2023
- Last updated
- 13 Jul 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 13 Jul 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Difference Between Daily and Alternative Day Use of Icodextrin in Peritoneal Dialysis
- ClinicalTrials.gov ID
- NCT05943470
- Acronym / sponsor ID
- LY2023-083
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 74 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Aug 2023 (estimated)
- Primary completion
- 31 Dec 2023 (estimated)
- Study completion
- 28 Dec 2024 (estimated)
- First posted
- 13 Jul 2023 (actual)
- 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.
Volume overload is an important cause of technical failure in peritoneal dialysis patients. Icodextrin can provide continuous ultrafiltration, which provides a new option for peritoneal dialysis patients.
However, icodextrin metabolites are known to accumulate to some extent in the body, resulting in less ultrafiltration with long-term icodextrin use comparing with newly use.
Therefore, the investigator hypothesized that a single dose of icodextrin would produce more ultrafiltration volume with the use of icodextrin dialysate on alternate days than with the use of icodextrin dialysate on daily uses.
Detailed description
- Patients who met the inclusion criteria will be enrolled in this study.
- Randomization.
- Treatment A: daily icodextrin for 2 weeks. Treatment B: icodextrin is used every other day and original glucose-based dialysate is used every other day for a total of 2 weeks. The duration of icodextrin exchange is unchanged from the participants' original dialysate exchange regimen (typically, 8 to 14 hours). The interval is two weeks (the original dialysate was resumed). Participants would receive treatment A-B or B-A, depending on randomization.
- Participants would record daily peritoneal ultrafiltration volume, long dwell ultrafiltration volume, dialysis prescription, urine volume, body weight, home blood pressure monitoring and complaints of discomfort.
- Before the start of treatment (day 0), after the end of treatment period 1 (day14), at the end of washout period (day28), and at the end of treatment period 2 (day42), blood samples are collected for blood glucose, blood lipids, BNP, amylase, blood electrolytes, alkaline phosphatase. The participants' weight, blood pressure, dialysis prescription, daily ultrafiltration volume, urine volume, long dwell ultrafiltration volume and BCM measurement results would be recorded on the visit day. In the last 10 enrolled patients, blood samples would be collected for detection of icodextrin metabolites. After the end of treatment period 2, participants could choose the prescription of dialysate according to their own wishes and would be followed up for another 2 weeks.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Crossover
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| daily | Active comparator | Drug: Icodextrin Peritoneal Dialysis Solutiondaily use of one exchange of icodextin as long dwell |
| alternative day | Experimental | Drug: Icodextrin Peritoneal Dialysis Solutionalternative day use of one exchange of icodextin as long dwell |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 1. End-stage renal failure
- 2. Patients with regular peritoneal dialysis in our center
- 3. 18-75 years old
- 4. Patients who currently use glucose dialysate for prolonged abdominals
- 5. Sign informed consent
Key exclusion criteria (5 listed)
- 1. The expected survival time is less than 3 months
- 2. Known peritoneal dialysis tube dysfunction
- 3. Peritonitis occurred within one month
- 4. Known peritoneal effusion
- 5. Known allergy to icodextrin
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 |
|---|---|---|
| Icodextrin Peritoneal Dialysis SolutionAlso: Extranealalternative day use of icodextrin comparing with daily use of icodextrin | Drug | alternative day, daily |
Primary outcome
ultrafiltration measured in ml
Time frame: 2 weeks
ultrafiltration volume for single icodextrin dwell
1 secondary outcome
daily treatment cost measured in Chinese Yuan
Time frame: 2 weeks
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 13 Jul 2023.
- Individual participant dataSharing planned: No
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.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Icodextrin Peritoneal Dialysis Solution in people with Peritoneal Dialysis Solution Adverse Reaction, run by RenJi Hospital.
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 5 inclusion and 5 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 13 Jul 2023. Status can change between updates, so confirm with the study contact before making plans.
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?
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?
ultrafiltration measured in ml (time frame: 2 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 13 Jul 2023.