Comparing nighttime and daytime peritoneal dialysis effectiveness
Comparison of Efficacy Between Nighttime vs Daytime Peritoneal Dialysis in Non-diabetic Patients: a Randomized, Open-label, Cross-over, Multi-center Clinical Trial
This study is testing whether nighttime peritoneal dialysis works better than daytime dialysis for people with end-stage kidney disease who don’t have diabetes.
Quick facts
| Phase | Not applicable |
|---|---|
| Study type | Interventional |
| Enrollment | 124 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Nanfang Hospital, Southern Medical University Academic / other |
| Locations | 1 site (Guangzhou, Guangdong) |
| Trial ID | NCT05449067 on ClinicalTrials.gov |
What this trial studies
This clinical trial investigates the efficacy of nocturnal continuous cyclic peritoneal dialysis (NCPD) compared to continuous ambulatory peritoneal dialysis (CAPD) in non-diabetic patients with end-stage kidney disease. The study is designed as a randomized, open-label, cross-over, multi-center trial involving 124 participants. The primary objective is to assess the adequacy of peritoneal dialysis between the two methods, while secondary objectives include evaluating quality of life factors such as sleep quality and blood pressure. Participants will be monitored for changes in dialysis adequacy over a specified treatment period.
Who should consider this trial
Good fit: Ideal candidates are non-diabetic patients aged 18 to 75 who have been on maintenance peritoneal dialysis for at least one month.
Not a fit: Patients with diabetes mellitus or those with certain acute medical conditions may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide insights into a more effective dialysis method that improves patients' quality of life.
How similar studies have performed: Previous studies have explored similar dialysis methods, but this specific comparison of NCPD and CAPD is novel.
Eligibility criteria
Show full inclusion / exclusion criteria
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/V ≥ 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.
Where this trial is running
Guangzhou, Guangdong
- Nanfang Hospital of Southern Medical University — Guangzhou, Guangdong, China (Recruiting)
Study contacts
- Principal investigator: Fanfan Hou, MD,PhD — Nanfang Hospital, Southern Medical University
- Study coordinator: Fanfan Hou, MD,PhD
- Email: ffhouguangzhou@163.com
- Phone: +86-020-61641591
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.