Nocturnal APD vs. CAPD in Non-diabetic ESKD

NCT05449067 | Completed DMC

• 1 other identifier: NFEC-2022-188
• Study Type: interventional
• Target: 137
• Locations: 1 country
• Sites: 1

Brief Summary

Background: Continuous ambulatory peritoneal dialysis (CAPD) imposes a substantial daytime burden. Nocturnal automated peritoneal dialysis (APD) may improve patient-centered outcomes, but high-quality evidence is lacking. We aimed to determine whether nocturnal APD is non-inferior to CAPD in solute clearance and to evaluate patient-centered outcomes. Design: A multicenter, randomized, open-label, crossover non-inferiority trial. Primary Objective: To compare the adequacy of peritoneal dialysis between nocturnal APD and CAPD in non-diabetic patients. Secondary Objective: To compare the effects of nocturnal APD and CAPD on the quality of life, social functioning, sleep quality, blood pressure, and daily ultrafiltration volume. Hypothesis: In non-diabetic patients, nocturnal APD is non-inferior to CAPD in peritoneal dialysis adequacy. Methods:Eligible participants were randomly assigned in a 1:1 ratio to one of two treatment groups using a centralized block randomization system, stratified by study center. Group A consisted of 12 weeks of nocturnal APD followed by 12 weeks of CAPD; Group B consisted of the reverse order. The randomization code was generated by an independent statistical center. The trial comprised a screening period, two 12-week treatment periods, and a follow-up period. After screening and baseline assessments, participants initiated their assigned treatment sequence. Scheduled outpatient visits occurred every 4 weeks (±5 days) for safety monitoring and routine laboratory testing. Comprehensive outcome assessments were performed at week 12 (end of the first period) and week 24 (end of the second period). Additional unscheduled visits were arranged as needed in the event of adverse events or clinical changes.

Conditions

End-Stage Kidney Disease; Peritoneal Dialysis

Keywords

Nocturnal Automated Peritoneal Dialysis; Continuous Ambulatory Peritoneal Dialysis; Dialysis Adequacy; Sleep quality; Health-related Quality of Life

Outcome Measures

Primary Outcomes (1)

• Total Weekly Kt/V

  The primary outcome was the steady-state weekly total Kt/V. For the first treatment period, it was defined as the arithmetic mean of weekly total Kt/V values measured at weeks 8 and 12; for the second treatment period, as the arithmetic mean of values measured at weeks 20 and 24. If one measurement was missing within a period, the single available value was used as the steady-state value for that period.Weekly total Kt/V was calculated as (24-hour dialysate urea clearance + 24-hour urine urea clearance) / (serum urea nitrogen concentration × urea distribution volume) × number of dialysis days per week. Urea distribution volume was estimated using the Watson formula.

  Week 0, 4, 8, 12, 16, 20, and 24

Secondary Outcomes (5)

• Sleep Quality

  Week 12, and 24

• Health-related Quality of Life and Social Function

  Week 0, 12, and 24

• Ambulatory Blood Pressure (ABP)

  Week 0, 12, and 24

• Ultrafiltration Volume (UV)

  UV is recorded daily, with analysis based on the mean of the final 7 days of each treatment period

• Social functioning

  Week 0, 12, and 24

Study Arms (2)

Group A

EXPERIMENTAL

Participants receive nocturnal APD for 12 weeks and then switch to CAPD for another 12 weeks.

Procedure: Nocturnal automated peritoneal dialysis (APD); Procedure: Continuous Ambulatory Peritoneal Dialysis (CAPD)

Group B

EXPERIMENTAL

Participants receive CAPD for 12 weeks and then switch to nocturnal APD for another 12 weeks

Procedure: Nocturnal automated peritoneal dialysis (APD); Procedure: Continuous Ambulatory Peritoneal Dialysis (CAPD)

Interventions

Nocturnal automated peritoneal dialysis (APD) PROCEDURE

Nocturnal APD was delivered using automated cyclers (Dongze Medical, Fuzhou, China).During the night, a total of 4 exchanges were conducted, with 2000ml of dialysate infused into the abdominal cavity each time and retained for 2.5 hours, resulting in a total treatment duration of 10 hours; during the day, 2000ml of dialysate was retained.

Group A; Group B

Continuous Ambulatory Peritoneal Dialysis (CAPD) PROCEDURE

CAPD was performed with three to five manual exchanges per day. Single intraperitoneal infusion of 2000ml of dialysate, with a single dwell time of 4 hours during the day; and a dwell time of 10-12 hours at night

Group A; Group B

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Age 18 to 75 years;
• Maintenance peritoneal dialysis for ≥ 1 month;
• Weekly total CrCl ≥ 45 liters/week/1.73m2 body surface area;
• Total weekly Kt/V ≥ 1.7.

You may not qualify if:

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

Sponsors & Collaborators

• Nanfang Hospital, Southern Medical University: lead
• Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University: collaborator
• Fifth Affiliated Hospital, Sun Yat-Sen University: collaborator
• The First Affiliated Hospital of Guangzhou Medical University: collaborator
• Guangdong Provincial Hospital of Traditional Chinese Medicine: collaborator
• Fujian Provincial Hospital: collaborator
• The Affiliated Ganzhou Hospital of Nanchang University: collaborator
• Second Affiliated Hospital of Guangzhou Medical University: collaborator
• First People's Hospital of Yulin: collaborator
• Dongguan Tungwah Hospital: collaborator
• Guizhou Provincial People's Hospital: collaborator
• The First People's Hospital of Nanning: collaborator
• Tianjin Medical University Second Hospital: collaborator
• Guangzhou First People's Hospital: collaborator
• Fuzhou First General Hospital Affiliated with Fujian Medical University: collaborator

Study Sites (1)

Nanfang Hospital of Southern Medical University

Guangzhou, Guangdong, 510015, China

Location

Related Publications (10)

• Guo A, Mujais S. Patient and technique survival on peritoneal dialysis in the United States: evaluation in large incident cohorts. Kidney Int Suppl. 2003 Dec;(88):S3-12. doi: 10.1046/j.1523-1755.2003.08801.x.

  PMID: 14870873 BACKGROUND

• Li PK, Chow KM, Van de Luijtgaarden MW, Johnson DW, Jager KJ, Mehrotra R, Naicker S, Pecoits-Filho R, Yu XQ, Lameire N. Changes in the worldwide epidemiology of peritoneal dialysis. Nat Rev Nephrol. 2017 Feb;13(2):90-103. doi: 10.1038/nrneph.2016.181. Epub 2016 Dec 28.

  PMID: 28029154 BACKGROUND

• Bieber SD, Burkart J, Golper TA, Teitelbaum I, Mehrotra R. Comparative outcomes between continuous ambulatory and automated peritoneal dialysis: a narrative review. Am J Kidney Dis. 2014 Jun;63(6):1027-37. doi: 10.1053/j.ajkd.2013.11.025. Epub 2014 Jan 11.

  PMID: 24423779 BACKGROUND

• Rabindranath KS, Adams J, Ali TZ, Daly C, Vale L, Macleod AM. Automated vs continuous ambulatory peritoneal dialysis: a systematic review of randomized controlled trials. Nephrol Dial Transplant. 2007 Oct;22(10):2991-8. doi: 10.1093/ndt/gfm515. Epub 2007 Sep 17.

  PMID: 17875571 BACKGROUND

• Roumeliotis A, Roumeliotis S, Leivaditis K, Salmas M, Eleftheriadis T, Liakopoulos V. APD or CAPD: one glove does not fit all. Int Urol Nephrol. 2021 Jun;53(6):1149-1160. doi: 10.1007/s11255-020-02678-6. Epub 2020 Oct 13.

  PMID: 33051854 BACKGROUND

• Beduschi Gde C, Figueiredo AE, Olandoski M, Pecoits-Filho R, Barretti P, de Moraes TP; all centers that contributed to the BRAZPD. Automated Peritoneal Dialysis Is Associated with Better Survival Rates Compared to Continuous Ambulatory Peritoneal Dialysis: A Propensity Score Matching Analysis. PLoS One. 2015 Jul 27;10(7):e0134047. doi: 10.1371/journal.pone.0134047. eCollection 2015.

  PMID: 26214801 BACKGROUND

• Jung HY, Jang HM, Kim YW, Cho S, Kim HY, Kim SH, Bang K, Kim HW, Lee SY, Jo SK, Lee J, Choi JY, Cho JH, Park SH, Kim CD, Kim YL; EQLIPS Study Group. Depressive Symptoms, Patient Satisfaction, and Quality of Life Over Time in Automated and Continuous Ambulatory Peritoneal Dialysis Patients: A Prospective Multicenter Propensity-Matched Study. Medicine (Baltimore). 2016 May;95(21):e3795. doi: 10.1097/MD.0000000000003795.

  PMID: 27227956 BACKGROUND

• Michels WM, van Dijk S, Verduijn M, le Cessie S, Boeschoten EW, Dekker FW, Krediet RT; NECOSAD Study Group. Quality of life in automated and continuous ambulatory peritoneal dialysis. Perit Dial Int. 2011 Mar-Apr;31(2):138-47. doi: 10.3747/pdi.2010.00063. Epub 2011 Feb 28.

  PMID: 21357936 BACKGROUND

• Cortes-Sanabria L, Paredes-Cesena CA, Herrera-Llamas RM, Cruz-Bueno Y, Soto-Molina H, Pazarin L, Cortes M, Martinez-Ramirez HR. Comparison of cost-utility between automated peritoneal dialysis and continuous ambulatory peritoneal dialysis. Arch Med Res. 2013 Nov;44(8):655-61. doi: 10.1016/j.arcmed.2013.10.017. Epub 2013 Nov 8.

  PMID: 24211750 BACKGROUND

• Driehuis E, Eshuis M, Abrahams A, Francois K, Vernooij RW. Automated peritoneal dialysis versus continuous ambulatory peritoneal dialysis for people with kidney failure. Cochrane Database Syst Rev. 2024 Sep 11;9(9):CD006515. doi: 10.1002/14651858.CD006515.pub2.

  PMID: 39258519 DERIVED

MeSH Terms

Conditions

Kidney Failure, Chronic; Sleep Initiation and Maintenance Disorders

Interventions

Peritoneal Dialysis, Continuous Ambulatory

Condition Hierarchy (Ancestors)

Renal Insufficiency, Chronic; Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Sleep Disorders, Intrinsic; Dyssomnias; Sleep Wake Disorders; Nervous System Diseases; Mental Disorders

Intervention Hierarchy (Ancestors)

Ambulatory Care; Patient Care; Therapeutics; Peritoneal Dialysis; Renal Dialysis; Renal Replacement Therapy; Sorption Detoxification; Health Services; Health Care Facilities Workforce and Services

Study Officials

• Fanfan Hou, MD,PhD

  Nanfang Hospital, Southern Medical University

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: The trial was open-label with respect to treatment assignment, as the nature of the interventions precluded blinding of participants and treating clinicians. However, outcome adjudicators and data analysts were masked to treatment allocation throughout the analysis period. All outcome data were reviewed by an independent clinical events committee whose members were unaware of treatment assignment.
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Model Details: Eligible participants were randomly assigned in a 1:1 ratio to one of two treatment sequences using a centralized block randomization system, stratified by study center. Sequence A consisted of 12 weeks of nocturnal APD followed by 12 weeks of CAPD; sequence B consisted of the reverse order. The randomization code was generated by an independent statistical center.

Study Record Dates

• First Submitted: June 22, 2022
• First Posted: July 8, 2022
• Study Start: May 26, 2022
• Primary Completion: February 11, 2026
• Study Completion: February 11, 2026
• Last Updated: April 28, 2026

Record last verified: 2026-04

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)