Clinical trial NCT06119373: Incremental PD With Single Icodextrin Exchange
Official title: Initiation of Incremental Dialysis With Single Daily Icodextrin Exchange: a Randomized Controlled Trial
Study type: INTERVENTIONAL
Overall status: NOT_YET_RECRUITING
Phase: NA
Conditions: Peritoneal Dialysis Complication
Residual Kidney Function
Survival
Health-related Quality of Life
Lead sponsor: RenJi Hospital
Sponsor class: OTHER
First posted: 2023-11-07
Enrollment: 72
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

Brief 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.

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.

Eligibility criteria: Inclusion Criteria:

1. male or female patients aged 18 to 75 years;
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:

1. documented anaphylaxis with icodextrin or glucose-based dialysate;
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.

Primary outcomes:
measure: Residual kidney function
timeFrame: Up to 48 weeks after recruitment
Secondary outcomes:
measure: Mortality
timeFrame: Up to 48 weeks after recruitment
measure: Peritonitis-free survival
timeFrame: Up to 48 weeks after recruitment
measure: Health-related quality of life
timeFrame: Up to 48 weeks after recruitment
measure: Volume status
timeFrame: Up to 48 weeks after recruitment
measure: Adequacy of small molecular solute clearance
timeFrame: Up to 48 weeks after recuritment
measure: glucose exposure to dialysate
timeFrame: Up to 48 weeks after recuritment
Other outcomes:
Locations:
Study officials:
affiliation: RenJi Hospital
name: Wei Fang, MD., PhD.
role: PRINCIPAL_INVESTIGATOR
References: