Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
NOT_YET_RECRUITING
NA
72 participants
INTERVENTIONAL
2023-12-01
2026-11-30
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
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.
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Icodextrin Postpones the Shift of Low Dose to Full Dose Dialysis in the First Year of Incremental Peritoneal Dialysis
NCT05721404
The Difference Between Daily and Alternative Day Use of Icodextrin
NCT05943470
Observational Study of the Use of Extraneal in Peritoneal Dialysis in Patients
NCT06492031
Efficacy and Safety of a 7.5% Icodextrin Peritoneal Dialysis Solution in Once-Daily Long Dwell Exchange
NCT00725517
Ultrafiltration Efficacy of a PD Solution Containing Icodextrin-Xylitol-Carnitine
NCT04086212
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
NONE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Single daily icodextrin exchange group
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.
Single daily icodextrin exchange
PD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution.
Conventional PD group
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.
Conventional PD group
PD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution.
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Single daily icodextrin exchange
PD initiation with single daily exchange of 2-liter icodextrin-based dialysis solution.
Conventional PD group
PD is initiated with 2 to 3 exchanges of 2-liter glucose-based dialysis solution.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. patients with chronic kidney disease stage 5 who are to start PD;
3. eGFR ≥ 5 ml/min;
4. urine output ≥ 800 ml/d.
Exclusion Criteria
2. concomitant severe chronic diseases such as malignancy, hepatitis, severe cardiac diseases, etc.;
3. ongoing severe infection;
4. planned or ongoing pregnancy or lactation;
5. currently enrolled in other clinical studies;
6. patients who have a life expectancy of \<12 months;
7. refusal to give a written consent.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
RenJi Hospital
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Wei Fang
Clinical Professor
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Wei Fang, MD., PhD.
Role: PRINCIPAL_INVESTIGATOR
RenJi Hospital
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
IIT-2022-0224
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.