The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients

Renal Insufficiency, Chronic Clinical Trial

Official title:

The Clinical Effects of Korean Adapted APD in Automated Peritoneal Dialysis Patients

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT01997385
• Other study ID #: KAAPD_01_112013
• Status: Completed
• Phase: Phase 4
• First received: November 13, 2013
• Last updated: January 21, 2016
• Start date: June 2012
• Est. completion date: June 2014

Study information

• Verified date: January 2016
• Source: Fresenius Medical Care Korea
• Contact: n/a
• Is FDA regulated: No
• Health authority: Korea: Institutional Review Board
• Study type: Interventional

Clinical Trial Summary

The aim of this study is to assess the impact of "adapted" Automated Peritoneal Dialysis(APD) sequentially prescribed shorter and longer dwell exchanges with smaller and larger fill volumes in comparison with "conventional APD" prescribed a standard continuous cycling peritoneal dialysis on the efficacy of dialysis.

Description:

It is well known that the efficiency of peritoneal dialysis (PD) varies with the duration of the dwell and the prescribed fill volume. Short dwell ensures adequate UF because the osmotic gradient is maintained while prolonged dwell allows for more solute clearance because the dialysate-to-plasma ratio (D/P) for uremic toxins such as creatinine and phosphate enhances. In terms of intraperitoneal fill volume, large fill volume improves the removal of uremic toxins for two reasons: a larger volume can be drained and therefore the clearance achieved is greater, and the peritoneal surface area available for the exchange is increased. Conversely, small fill volume promotes the process of UF because of the potentially low intraperitoneal pressure (IPP). Overall, choosing the optimal dwell time and exchange volume should promote UF and increase the removal of uremic toxins—urea in particular—to the dialysate.

Thus, this study proposes a new way of giving PD, using a modified version of conventional prescription which firstly uses 2 cycles of short dwell time with a small fill volume to promote UF and subsequently uses 2 cycles of longer dwell time and a larger fill volume to promote removal of uremic toxins from the blood.

Although it was already evaluated the efficiency of this modified prescription by Fischbach et al, the prescription currently prescribed in most Korean hospitals shows some differences in dwell time, fill volume and exchange cycling. The aim of this study is to assess the clinical effect of "Korean Adapted APD" (KAPD-A) compared to "Korean Conventional APD" (KAPD-C).

This is a multicenter, randomized, open-label, parallel controlled study. Patients who meet inclusion criteria will be randomized into each group at the ratio of 1:1. For incident patients, after being stable on APD and peritonitis-free at least 4 weeks, which is called as "run-in period", group 1 will start with 8 weeks of KAPD-C treatment and then cross over to 8 weeks of treatment with KAPD-A while group 2 will be performed on the contrary from KAPD-A to KAPD-C treatment.

Each patient will receive the same total amount of dialysate (8000 mL), given over the same 8-hour duration. First at the inclusion visit called "as baseline", and then visits will take place every 4 weeks for a total of 16 weeks.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 1075
• Est. completion date: June 2014
• Est. primary completion date: April 2014
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 20 Years to 75 Years

Eligibility

Inclusion Criteria:

• End stage of Renal Disease(ESRD) patients with indication for renal replacement therapy

• D/P Creatinine above 0.5 as evaluated by a 4-hour peritoneal equilibration test(PET) at screening

• Stable on APD and peritonitis-free for at least 4 weeks(run-in phase) in case of incident patients who chose APD

• Peritonitis-free within 4 weeks in case of maintaining patients who treated with APD in current

• Written informed consent to study participation and data submission

Exclusion Criteria:

• Planned to kidney transplantation within 5 months

• Patients with ascites because of the progressed cirrhosis of the liver

• Suspected or confirmed pregnancy

• Prior enrolment in another clinical trial

Study Design

Allocation: Non-Randomized, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment

Related Conditions & MeSH terms

• Renal Insufficiency
• Renal Insufficiency, Chronic

Intervention

Procedure:
• KAPD-C
KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.
• KAPD-A
KAPD-A is a treatment initially prescribed 1500 mL fill volume per each 2 cycles of dialysis session with an exchange cycle of 45 minutes and followed by 2 cycles of 2500 mL fill volume with an exchange cycle of 135 minutes.

Locations

Country	Name	City	State
Korea, Republic of	Samsung Medical Center	Seoul

Sponsors (1)

Lead Sponsor	Collaborator
Fresenius Medical Care Korea

Country where clinical trial is conducted

Korea, Republic of, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A		at 4,8,12,16 weeks from baseline	No
Primary	Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A		at 4,8,12,16 weeks from baseline	No
Primary	Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A		at 4,8,12,16 weeks from baseline	No
Secondary	Difference in phosphate dialytic removal between KAPD-C and KAPD-A		at 4,8,12,16 weeks from baseline	No
Secondary	Difference in corrected for glucose absorption between KAPD-C and KAPD-A		at 4,8,12,16 weeks from baseline	No