Comparison of Efficacy Between Nighttime and Daytime Peritoneal Dialysis
NCT ID: NCT05449067
Last Updated: 2025-08-22
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
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RECRUITING
NA
124 participants
INTERVENTIONAL
2022-05-26
2025-12-30
Brief Summary
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Design: Randomized, open-label, cross-over, multi-center clinical trial.
Objective:
Primary Objective: To compare the adequacy of peritoneal dialysis between NCPD and CAPD in non-diabetic patients.
Secondary Objective: To compare the effects of NCPD and CAPD on the quality of life, including sleep quality, nocturnal blood pressure, and ultra-filtration volume in non-diabetic patients.
Hypothesis: In non-diabetic patients, NCDP is non-inferior to CAPD in peritoneal dialysis adequacy.
Methods: A total of 124 non-diabetic peritoneal dialysis patients will be enrolled and randomly assgined into two groups in a 1:1 ratio. Patients in group A will receive NCPD treatment from 1 to 12 weeks and then switch to CAPD treatment from 13 to 24 weeks, while patients in group B will receive CAPD treatment from 1 to 12 weeks and then switch to NCPD treatment from 13 to 24 weeks. All patients are required to sign an informed consent before enrollment. The enrolled patients are planned to be followed every 4 weeks, and unplanned visits will be arranged if necessary. The peritoneal dialysis adequacy (weekly total Kt/V) of the patients will be assessed at baseline and at the corresponding visit points. The average daily ultra-filtration volume during the two modalities of treatment will be compared. Sleep quality parameters will be collected using a contact-free continuous vital signs monitoring equipment at baseline, Week 12 and Week 24. The health-related quality of life and social function will be analyzed using the Kidney Disease Quality of Life 36-item short form survey (KDQOL-36) and Social Disability Screening Schedule (SDSS) questionnaire. Twenty-four-hour Ambulatory Blood Pressure (ABP) will be monitored at baseline, Week 12, and Week 24.
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Detailed Description
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Clinical data from previous studies showed that the total weekly Kt/V of non-diabetic peritoneal dialysis patients was 2.4 (95% CI: 1.46-3.38), the change in Kt/V after 3 months of treatment was -0.02 (95% CI: -0.64-0.59), and the standard deviation of the change was 0.31 (95% CI: 0.26-0.36). Based on the above data, we estimated the sample size.
For the primary efficacy outcome (the difference of Kt/V score between NCPD and CAPD patients), the non-inferiority test shows that 110 patients could provide 90% power to detect an absolute difference of 0 when the margin of non-inferiority is 0.1 with a common standard deviation of 0.36 at one-sided significance level α=0.025. Considering the 10% rate of loss to follow-up, 124 cases (62 cases in each sequence) will be enrolled.
Conditions
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Study Design
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RANDOMIZED
CROSSOVER
TREATMENT
SINGLE
Study Groups
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Nocturnal Continuous Cyclical Peritoneal Dialysis (NCPD)
In NCPD, patients uses a machine to exchange fluid to perform dialysis at night.
Group A and Group B
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Continuous Ambulatory Peritoneal Dialysis (CAPD)
In CAPD, patients perform dialysis with manual fluid change at daytime .
Group A and Group B
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Interventions
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Group A and Group B
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Group A and Group B
Group A: Participants receive NCPD for 12 weeks and then switch to CAPD for another 12 weeks.Group B: Participants receive CAPD for 12 weeks and then switch to NCPD for another 12 weeks.
Eligibility Criteria
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Inclusion Criteria
2. Maintenance peritoneal dialysis for ≥ 1 month;
3. Weekly total CrCL ≥ 45 liters/week/1.73m2 body surface area;
4. Total weekly Kt/V ≥ 1.7.
Exclusion Criteria
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.
18 Years
75 Years
ALL
No
Sponsors
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Sun Yat-Sen Memorial Hospital of Sun Yat-Sen University
OTHER
Fifth Affiliated Hospital, Sun Yat-Sen University
OTHER
The First Affiliated Hospital of Guangzhou Medical University
OTHER
Guangdong Provincial Hospital of Traditional Chinese Medicine
OTHER
Fujian Provincial Hospital
OTHER
The Affiliated Ganzhou Hospital of Nanchang University
OTHER
Second Affiliated Hospital of Guangzhou Medical University
OTHER
First People's Hospital of Yulin
OTHER
Dongguan Tungwah Hospital
OTHER
Guizhou Provincial People's Hospital
OTHER
The First People's Hospital of Nanning
UNKNOWN
Tianjin Medical University Second Hospital
OTHER
Guangzhou First People's Hospital
OTHER
Fuzhou First General Hospital Affiliated with Fujian Medical University
UNKNOWN
Nanfang Hospital, Southern Medical University
OTHER
Responsible Party
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Principal Investigators
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Fanfan Hou, MD,PhD
Role: PRINCIPAL_INVESTIGATOR
Nanfang Hospital, Southern Medical University
Locations
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Nanfang Hospital of Southern Medical University
Guangzhou, Guangdong, China
Countries
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Central Contacts
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Facility Contacts
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References
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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.
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.
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.
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.
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.
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.
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.
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.
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.
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.
Other Identifiers
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NFEC-2022-188
Identifier Type: -
Identifier Source: org_study_id
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