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

January 21, 2016 updated by: Fresenius Medical Care Korea
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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1075

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 75 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Non-Randomized
  • Interventional Model: Crossover Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Active Comparator: 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.
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.
Experimental: 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.
Procedure: 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.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Time Frame
Difference in overnight peritoneal ultrafiltration (UF) between KAPD-C and KAPD-A
Time Frame: at 4,8,12,16 weeks from baseline
at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal Kt/V urea between KAPD-C and KAPD-A
Time Frame: at 4,8,12,16 weeks from baseline
at 4,8,12,16 weeks from baseline
Difference in weekly peritoneal creatinine clearance between KAPD-C and KAPD-A
Time Frame: at 4,8,12,16 weeks from baseline
at 4,8,12,16 weeks from baseline

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Time Frame
Difference in phosphate dialytic removal between KAPD-C and KAPD-A
Time Frame: at 4,8,12,16 weeks from baseline
at 4,8,12,16 weeks from baseline
Difference in corrected for glucose absorption between KAPD-C and KAPD-A
Time Frame: at 4,8,12,16 weeks from baseline
at 4,8,12,16 weeks from baseline

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Fresenius Medical Care Korea

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Daejoong Kim, Prof., Division of Nephrology, Samsung Medical Center

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
June 1, 2012

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 1, 2014

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
June 1, 2014

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
November 13, 2013

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 22, 2013

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 28, 2013

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
January 22, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
January 21, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
January 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • KAAPD_01_112013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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