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

NCT01997385 | Completed Phase 4

• 1 other identifier: KAAPD_01_112013
• Study Type: interventional
• Target: 1,075
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Renal Insufficiency, Chronic

Keywords

adapted APD; dwell time; fill volume

Outcome Measures

Primary Outcomes (3)

• Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A

  at 4,8,12,16 weeks from baseline

• Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A

  at 4,8,12,16 weeks from baseline

• Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A

  at 4,8,12,16 weeks from baseline

Secondary Outcomes (2)

• Difference in phosphate dialytic removal between KAPD-C and KAPD-A

  at 4,8,12,16 weeks from baseline

• Difference in corrected for glucose absorption between KAPD-C and KAPD-A

  at 4,8,12,16 weeks from baseline

Study Arms (2)

KAPD-C

ACTIVE COMPARATOR

KAPD-C is a treatment prescribed 2000 mL fill volume per each 4 cycles of dialysis session with an exchange cycle of 90 minutes.

Procedure: KAPD-C

KAPD-A

EXPERIMENTAL

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.

Procedure: KAPD-A

Interventions

KAPD-C PROCEDURE

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-C

KAPD-A PROCEDURE

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.

KAPD-A

Eligibility Criteria

• Age: 20 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Fresenius Medical Care Korea: lead

Study Sites (1)

Samsung Medical Center

Seoul, South Korea

Location

MeSH Terms

Conditions

Renal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

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

Study Officials

• Daejoong Kim, Prof.

  Division of Nephrology, Samsung Medical Center

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NON RANDOMIZED
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: CROSSOVER
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: November 13, 2013
• First Posted: November 28, 2013
• Study Start: June 1, 2012
• Primary Completion: April 1, 2014
• Study Completion: June 1, 2014
• Last Updated: January 22, 2016

Record last verified: 2016-01

Data Sharing

• IPD Sharing: Will not share

Locations

KR (1)