Peritoneal Dialysis ComplicationNCT06119373
Incremental PD With Single Icodextrin Exchange
A study testing Single daily icodextrin exchange and Conventional PD group in people with Peritoneal Dialysis Complication and Residual Kidney Function, run by RenJi Hospital.
Trial summary
Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD). Subjects: Seventy-two incident PD patients. Methods: A single-center randomized controlled trial. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Peritoneal Dialysis Complication, Residual Kidney Function, Survival
- What is being tested?
- Single daily icodextrin exchange and Conventional PD group
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 72 participants
- Where
- No sites listed yet
- Study dates
- 1 Dec 2023to 30 Nov 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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
- male or female patients aged 18 to 75 years;
- patients with chronic kidney disease stage 5 who are to start PD;
- eGFR ≥ 5 ml/min;
- urine output ≥ 800 ml/d.
Who cannot join
- documented anaphylaxis with icodextrin or glucose-based dialysate;
- concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;
- ongoing severe infection;
- planned or ongoing pregnancy or lactation;
- currently enrolled in other clinical studies;
- patients who have a life expectancy of <12 months;
- refusal to give a written consent.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: Initiation of Incremental Dialysis With Single Daily Icodextrin Exchange: a Randomized Controlled Trial
Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD).
Subjects: Seventy-two incident PD patients.
Methods: A single-center randomized controlled trial.
Primary outcome: Change in residual kidney function in 48 weeks after recruitment.
Read the detailed description
Incremental peritoneal dialysis (PD) has become a more prevalently adopted strategy in incident PD patients. There is significant variation in regimens of incremental PD. Initiation of PD with a single daily icodextrin exchange in patients with considerable residual kidney function is able to achieve successful water, sodium removal and solute clearance, while it has not been investigated and validated in randomized controlled trials.
This single-center, randomized, controlled study is to compare the effects of two prescriptions for initiation of incremental PD, a single daily icodextrin exchange versus 2-3 exchanges of glucose-based dialysate, on patients' residual kidney function, survival, peritonitis, and quality of life, in order to develop a new paradigm of incremental PD.
The primary outcome is change of residual kidney function, and the secondary outcomes include mortality, peritonitis-free survival, health-related quality of life, volume status, adequacy of small molecular solute clearance, and glucose exposure to dialysate.
Seventy-two eligible incident PD patients will be enrolled and randomly assigned to either the experimental or the control group in a ration of 1:1. Patients of the experimental group initiate PD with once daily exchange of 2-liter icodextrin dialysate, while those of the control group initiate PD with 2 to 3 exchanges of 2-liter glucose-based dialysate per day. All the enrolled patients will be prospectively followed up for 48 weeks. During the follow-up, the dose of dialysis would be incremental increased by adding exchange of glucose-based solution as required to accommodate for decline of RKF when at least one of the following indications is met: (1) clinical manifestations of uremia due to insufficient small solute clearance; (2) fluid overload which could not be corrected by salt and water intake restriction, increasing glucose concentration of dialysate, and administration of diuretics.
Residual kidney function, urine volume, peritoneal ultrafiltration, biochemical parameters, dialysate glucose exposure, volume status (measured by bioimpedence), and solute clearance are measured at baseline, and 24 and 48 weeks after recruitment, and are compared between groups. Quality of life is evaluated at baseline and 48 weeks by Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire, and are compared between two groups. Peritonitis rate for both groups are calculated and peritonitis-free survivals are compared. Differences in outcomes are evaluated by t test, Mann-Whitney test, or log-rank test where appropriate.
- Conditions
- Peritoneal Dialysis Complication, Residual Kidney Function, Survival, Health-related Quality of Life
- Being tested
- Single daily icodextrin exchange, Conventional PD group
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Single daily icodextrin exchangeOther
PD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution.
Conventional PD groupOther
PD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution.
| Study group | Role | What they receive |
|---|---|---|
| Single daily icodextrin exchange group | Experimental | For incident peritoneal dialysis (PD) patients assigned to the experimental arm, PD is initiated with single daily exchange of 2-liter icodextrin-based dialysis solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up. Receives: Other: Single daily icodextrin exchange |
| Conventional PD group | Active comparator | For incident peritoneal dialysis (PD) patients assigned to this arm, PD is initiated with 2 to 3 exchanges of 2-liter glucose-based solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up. Receives: Other: Conventional PD group |
What is being measured
The primary outcome is the main question the study is designed to answer.
Residual kidney function
Change of residual kidney function in 48 weeks after PD initiation
Measured: Up to 48 weeks after recruitment
Secondary outcomes (6)
Mortality
The endpoint was death. The censored events include transfer to permanent hemodialysis, recovery of renal function, loss to follow-up, transfer to other dialysis centers, or to the end of study.
Measured: Up to 48 weeks after recruitment
Peritonitis-free survival
The endpoint was first episode of PD-related peritonitis. The censored events were death, transfer to permanent hemodialysis, recovery of renal function, loss to follow-up, transfer to other dialysis centers, or to the end of study.
Measured: Up to 48 weeks after recruitment
Health-related quality of life
Change of health-related quality of life assessed using Kidney Disease Quality of Life-Short Form in 48 weeks after recruitment. The form generates a score of 0 to 100, which represents better quality of life by a higher value.
Measured: Up to 48 weeks after recruitment
Volume status
Change of volume status (Overhydration assessed by Bioelectric Impedance Analysis, etc.) in 48 weeks after recruitment
Measured: Up to 48 weeks after recruitment
Adequacy of small molecular solute clearance
Change of weekly Kt/V and clearance of creatinine assessed using standard methods in 48 weeks after recruitment
Measured: Up to 48 weeks after recuritment
glucose exposure to dialysate
change of glucose exposure to dialysate in 48 weeks after PD initiation
Measured: Up to 48 weeks after recuritment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 Nov 2023
- Study start1 Dec 2023 (estimated)
- Primary completion31 May 2026 (estimated)
- Study completion30 Nov 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Peritoneal Dialysis ComplicationStudies 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
- 72 participants (estimated)
Sponsor and investigators
- Lead sponsor
- RenJi Hospital
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Wei Fang, RenJi Hospital
- Investigators
- Wei Fang, MD., PhD., Principal investigator, RenJi Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06119373
- Sponsor's protocol ID
- IIT-2022-0224
- Status last verified
- Nov 2023
- First submitted
- 13 Oct 2023
- Last updated
- 8 Nov 2023
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 8 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Initiation of Incremental Dialysis With Single Daily Icodextrin Exchange: a Randomized Controlled Trial
- ClinicalTrials.gov ID
- NCT06119373
- Acronym / sponsor ID
- IIT-2022-0224
- Conditions
- Peritoneal Dialysis Complication, Residual Kidney Function, Survival, Health-related Quality of Life
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 72 participants (estimated)
- Lead sponsor
- RenJi HospitalUniversity, hospital or other
- Study start
- 1 Dec 2023 (estimated)
- Primary completion
- 31 May 2026 (estimated)
- Study completion
- 30 Nov 2026 (estimated)
- First posted
- 7 Nov 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.
Objectives: To investigate the efficacy and safety of single daily icodextrin exchange for initiation of incremental peritoneal dialysis (PD).
Subjects: Seventy-two incident PD patients.
Methods: A single-center randomized controlled trial.
Primary outcome: Change in residual kidney function in 48 weeks after recruitment.
Detailed description
Incremental peritoneal dialysis (PD) has become a more prevalently adopted strategy in incident PD patients. There is significant variation in regimens of incremental PD. Initiation of PD with a single daily icodextrin exchange in patients with considerable residual kidney function is able to achieve successful water, sodium removal and solute clearance, while it has not been investigated and validated in randomized controlled trials.
This single-center, randomized, controlled study is to compare the effects of two prescriptions for initiation of incremental PD, a single daily icodextrin exchange versus 2-3 exchanges of glucose-based dialysate, on patients' residual kidney function, survival, peritonitis, and quality of life, in order to develop a new paradigm of incremental PD.
The primary outcome is change of residual kidney function, and the secondary outcomes include mortality, peritonitis-free survival, health-related quality of life, volume status, adequacy of small molecular solute clearance, and glucose exposure to dialysate.
Seventy-two eligible incident PD patients will be enrolled and randomly assigned to either the experimental or the control group in a ration of 1:1. Patients of the experimental group initiate PD with once daily exchange of 2-liter icodextrin dialysate, while those of the control group initiate PD with 2 to 3 exchanges of 2-liter glucose-based dialysate per day. All the enrolled patients will be prospectively followed up for 48 weeks. During the follow-up, the dose of dialysis would be incremental increased by adding exchange of glucose-based solution as required to accommodate for decline of RKF when at least one of the following indications is met: (1) clinical manifestations of uremia due to insufficient small solute clearance; (2) fluid overload which could not be corrected by salt and water intake restriction, increasing glucose concentration of dialysate, and administration of diuretics.
Residual kidney function, urine volume, peritoneal ultrafiltration, biochemical parameters, dialysate glucose exposure, volume status (measured by bioimpedence), and solute clearance are measured at baseline, and 24 and 48 weeks after recruitment, and are compared between groups. Quality of life is evaluated at baseline and 48 weeks by Kidney Disease Quality of Life-Short Form (KDQoL-SF) questionnaire, and are compared between two groups. Peritonitis rate for both groups are calculated and peritonitis-free survivals are compared. Differences in outcomes are evaluated by t test, Mann-Whitney test, or log-rank test where appropriate.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Single daily icodextrin exchange group | Experimental | Other: Single daily icodextrin exchangeFor incident peritoneal dialysis (PD) patients assigned to the experimental arm, PD is initiated with single daily exchange of 2-liter icodextrin-based dialysis solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up. |
| Conventional PD group | Active comparator | Other: Conventional PD groupFor incident peritoneal dialysis (PD) patients assigned to this arm, PD is initiated with 2 to 3 exchanges of 2-liter glucose-based solution. The daily dwell time ranges from 8-24 hours per day, depending on the patient's clinical conditions. Additional exchange(s) of glucose-based dialysis solution will be added to increase uremic toxins and fluid removal if necessary during the follow-up. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- male or female patients aged 18 to 75 years;
- patients with chronic kidney disease stage 5 who are to start PD;
- eGFR ≥ 5 ml/min;
- urine output ≥ 800 ml/d.
Key exclusion criteria (7 listed)
- documented anaphylaxis with icodextrin or glucose-based dialysate;
- concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;
- ongoing severe infection;
- planned or ongoing pregnancy or lactation;
- currently enrolled in other clinical studies;
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 |
|---|---|---|
| Single daily icodextrin exchangePD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution. | Other | Single daily icodextrin exchange group |
| Conventional PD groupPD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution. | Other | Conventional PD group |
Primary outcome
Residual kidney function
Time frame: Up to 48 weeks after recruitment
Change of residual kidney function in 48 weeks after PD initiation
6 secondary outcomes
Mortality
Time frame: Up to 48 weeks after recruitment
Peritonitis-free survival
Time frame: Up to 48 weeks after recruitment
Health-related quality of life
Time frame: Up to 48 weeks after recruitment
Volume status
Time frame: Up to 48 weeks after recruitment
Adequacy of small molecular solute clearance
Time frame: Up to 48 weeks after recuritment
glucose exposure to dialysate
Time frame: Up to 48 weeks after recuritment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 8 Nov 2023.
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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.
Wei Fang, MD., PhD. principal investigator
RenJi Hospital
Questions about this trial
What is this clinical trial studying?
A study testing Single daily icodextrin exchange and Conventional PD group in people with Peritoneal Dialysis Complication and Residual Kidney Function, 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 4 inclusion and 7 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: opening soon, as of the sponsor's last update on 8 Nov 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.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Hao Yan, MD. (0086-13816588689, dryanhao@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Residual kidney function (time frame: Up to 48 weeks after recruitment). 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 8 Nov 2023.