CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients

November 12, 2023 updated by: Nanfang Hospital, Southern Medical University

The Effectiveness of CAPD Versus APD in Nondiabetic Peritoneal Dialysis Patients: A Multi-center, Randomized, Crossover Study

Background: Continuous ambulatory peritoneal dialysis (CAPD) and automated peritoneal dialysis (APD) are two important PD modalities. To date, only three small sample randomized control trials(RCTs) comparing CAPD and APD have been conducted but yield inconsistent results.

Objective: Investigators plan to initiate a multicenter, prospective, randomized cross-over study to compare the quality of life and dialysis adequacy in non-diabetic PD patients.

Hypothesis: Patients' quality of life and dialysis adequacy on APD is no worse than on CAPD.

Methods: This study plans to recruit 268 non-diabetic patients on maintenance peritoneal dialysis. Patients will randomly be assigned into groups A and B in a 1:1 ratio: group A receives APD from week 1 to 12 and changes to CAPD from week 13 to 24; group B receives CAPD from week 1 to 12 and changes to APD from week 13 to 24. Outcomes were evaluated at week 12 and week 24.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

This multicenter, randomized, open-label, crossover trial plans to recruit non-diabetic peritoneal dialysis patients by trained investigators according to the inclusion and exclusion criteria. At the beginning of the recruitment visit, each participant is asked to provide written informed consent in compliance with the Declaration of Helsinki and the requirements of the Independent Ethics Committee, after a careful explanation of the purpose and the procedures of the trial. Instructions for manual fluid exchange and automated peritoneal dialysis machines will be provided for each eligible patient, and they will be randomly assigned (1:1) to receive 12-week treatment in group A (APD-CCPD) and group B (CAPD), followed by a subsequent switch to the other modality. Safety assessments and routine visits were performed every 4 weeks thereafter, and efficacy assessments were performed at week 12 and week 24.

For the primary efficacy endpoint (the difference of Kt/V compared with baseline 3 months after treatment), 172 patients could provide 80% power to detect an absolute difference of 0.27 (10% of the mean) with a common SD of 0.46 (30% of the mean) at one-sided a=0.025. For another endpoint (the quality of life), previous studies have shown that the mean of a physical composite summary(PCS) score or a mental composite summary (MCS) score in the American population is about 50 points (SD=10), and a 2-point change in PCS or MCS is considered to be clinically significant. In this non-inferiority study, 196 patients could provide 80% power to detect an absolute difference of 4 points in mean change of PCS/MCS between groups at one-sided a=0.025. Considering the 10% rate of loss to follow-up, the sample size of each group was finally determined to be 108 cases.

Study Type

Interventional

Enrollment (Estimated)

216

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact Backup

  • Name: Jun Ai, MD
  • Phone Number: +8613570972948 +86-020-62787120
  • Email: aij1980@163.com

Study Locations

  • China
    • Guangdong
      • Guangzhou, Guangdong, China, 510015
        • Recruiting
        • Nanfang Hospital of Southern Medical University
        • Contact:
          • Jun Ai, Doctoral
          • Phone Number: +8613570972948 +86-020-62787120
          • Email: aij1980@163.com

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Age 18 to 75 years;
  2. Maintenance peritoneal dialysis for ≥ 1 month;
  3. Weekly total CrCL ≥ 45 liters/week/1.73m2 body surface area;
  4. Total weekly Kt/Vurea ≥ 1.7.

Exclusion Criteria:

  1. Patients with diabetes mellitus;
  2. Maintained peritoneal dialysis solution with a glucose concentration >2.5%;
  3. Combined with acute events of cardiovascular disease(CVD), cardiac function ≥ New York Heart Association (NYHA) class III;
  4. Episodes of peritonitis in the past 1 month;
  5. Abdominal surgery other than PD catheter insertion in the past 3 months;
  6. Planned kidney transplant in the last 6 months;
  7. Active hepatitis, cirrhosis, psychiatric disease, malignancy, pregnancy.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: Automated Peritoneal Dialysis (APD)
In APD, a mechanical device is employed to assist in the delivery and drainage of dialysate. Continuous Cycling Peritoneal Dialysis (CCPD)means patients receive four automated exchanges of 2 liters of dialysate each over 10 hours a night, with 2 liters left in the peritoneal cavity during the daytime. The overall dialysate volume is 10 liters.
Procedure: Group A and Group B
Group A: Participants receive APD for 12 weeks then switch to CAPD for another 12 weeks; Group B: Participants receive CAPD for 12 weeks and switch to APD for another 12 weeks.
Active Comparator: Continuous Ambulatory Peritoneal Dialysis (CAPD)
CAPD involves the manual instillation of 2 liters(L) of dialysis fluid into the peritoneal cavity, four times a day. This typically means three short dwells during the daytime and a long dwell overnight. The total volume of dialysate is 8 liters.
Procedure: Group A and Group B
Group A: Participants receive APD for 12 weeks then switch to CAPD for another 12 weeks; Group B: Participants receive CAPD for 12 weeks and switch to APD for another 12 weeks.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Assessment of standardized total urea clearance index(Kt/V)
Time Frame: up to 24 weeks
Kt/V = Kd×T/V. Kd is peritoneal urea nitrogen removal rate. T is the time (unit: min). V represents the urea distribution volume(weight×0.58)]
up to 24 weeks
Assessment of health-related quality of Life
Time Frame: up to 24 weeks

The abbreviated version of the Kidney Disease Quality Of Life Short Form 36 (KDQOL-36) is a self-reported questionnaire for assessing health-related quality of life (HRQOL). The scores of KDQOL-36 at the 12th week will be compared to that of the 24th week.

The KDQOL-36 contains 5 subscales with 36 items: the Physical Component Summary (PCS), Mental Component Summary (MCS), Burden of Kidney Disease (BKD), Symptoms and Problems of Kidney Disease (SPKD), and Effects of Kidney Disease (EKD). The raw scores are transformed linearly to a range of 0(minimum value) to 100(maximum value), with higher scores indicating better health-related quality of life.
up to 24 weeks

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Social Function
Time Frame: up to 24 weeks

Social Disability Screening Schedule(SDSS) score at the 12th week will be compared to that of the 24th week.

The SDSS scales were originally developed by the Disability Assessment Schedule of World Health Organization. The SDSS scale is composed of 10 items, which is used to assess social function. Each item is scored from 0 = healthy or very minor defects to 2 = severe defects. The minimum value is 0 and the maximum value is 20. A higher score means more severe impairment of a social function.
up to 24 weeks
Episodes of Peritonitis
Time Frame: The 24th week
PD patients presenting with cloudy effluent should be presumed to have peritonitis, which should be confirmed by obtaining effluent cell count, differential and culture.
The 24th week
Residual Renal Function
Time Frame: up to 24 weeks
Residual renal function should preferably be measured by 24h urine collection and calculation of the residual glomerular filtration rate, as represented by the average 24h urinary urea and creatinine clearances.
up to 24 weeks
24-hour ambulatory blood pressure(ABP)
Time Frame: up to 24 weeks
Participants wear a 24-hour ambulatory BP(blood pressure) monitor (conventional cuff-based oscillometric device) on their upper arm programmed to measure BP every 20 minutes during awake hours and every 30 minutes during asleep hours. Ambulatory BP data are extracted and processed by a single trained investigator. Investigators applied the American Heart Association's guidelines and defined daytime as 10 AM(ante meridiem) to 8 PM(post meridiem) and nighttime as midnight to 6 AM. At least 20 daytime and 7 nighttime readings were required for a participant's data to be included in the analysis. Investigators derive average daytime and nighttime BP, BP dip ratio (average nighttime BP divided by average daytime BP), and nighttime BP dipping (absolute difference between nighttime BP and daytime BP). BP dip ratios allow for the comparison of BP dipping in relation to daytime BP, thus providing a more comprehensive assessment of ambulatory BP patterns than absolute dipping alone.
up to 24 weeks
Standardized total creatinine clearance (CrCL)
Time Frame: up to 24 weeks

The weekly total CrCL was calculated as the arithmetic sum of weekly peritoneal CrCL and GFR.The weekly peritoneal CrCL (pCrCL,L) was calculated as follows: [(dialysate Cr/serum Cr) × drainage volume] × 7.Peritoneal CrCL was measured using the 24h dialysate collection.

The weekly glomerular filtration rate (GFR, L) was calculated as follows: [(renal urea CL + renal CrCL) × 12 ] × 7.

The weekly GFR was added to the weekly pCrCL to obtain the weekly total CrCL, which was normalized to a BSA (Body Surface Area) of 1.73 m2 .
up to 24 weeks
Daily average net ultrafiltration volume
Time Frame: up to 24 weeks
Net ultrafiltration volume was calculated as the volume of the drained dialysate(L) - the volume of infused dialysis fluid(L). The volume of the drained dialysate was measured by weighing the bag and subtracting the weight of the empty bag from the full bag.
up to 24 weeks

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nanfang Hospital, Southern Medical University

Collaborators

Guangdong Provincial Hospital of Traditional Chinese Medicine
Guangzhou First People's Hospital
Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
The First Affiliated Hospital of Guangzhou Medical University
Zhujiang Hospital
Fifth Affiliated Hospital, Sun Yat-Sen University
Fujian Provincial Hospital
The Affiliated Ganzhou Hospital of Nanchang University

Investigators

  • Principal Investigator: Fanfan Hou, MD,PhD, Nanfang Hospital, Southern Medical University

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

October 28, 2022

Primary Completion (Estimated)

June 1, 2024

Study Completion (Estimated)

December 1, 2024

Study Registration Dates

First Submitted

June 22, 2022

First Submitted That Met QC Criteria

July 3, 2022

First Posted (Actual)

July 8, 2022

Study Record Updates

Last Update Posted (Actual)

November 15, 2023

Last Update Submitted That Met QC Criteria

November 12, 2023

Last Verified

November 1, 2023

More Information

Terms related to this study

Keywords

Other Study ID Numbers

  • NFEC-2022-188

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

IPD Plan Description

During the study period, IPD is shared between the sponsor and collaborators. After the study is completed, IPD is available to other researchers on the condition of obtaining consent from the principal investigator.

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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