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PD-Improved Dialysis Efficiency With Adapted APD (PD-IDEA)

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT02470598
Recruitment Status : Completed
First Posted : June 12, 2015
Last Update Posted : August 6, 2020
Sponsor:
Information provided by (Responsible Party):
Fresenius Medical Care Deutschland GmbH

Tracking Information
First Submitted Date April 28, 2015
First Posted Date June 12, 2015
Last Update Posted Date August 6, 2020
Study Start Date March 2015
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Current Primary Outcome Measures
 (submitted: June 9, 2015)
Hydration status [ Time Frame: Every three months during one year ]
Assessed via body composition measurements
Original Primary Outcome Measures Same as current
Change History
Current Secondary Outcome Measures
 (submitted: June 9, 2015)
  • Residual renal function [ Time Frame: Every three months during one year ]
  • Changes in prescription [ Time Frame: Every three months during one year ]
  • Achievement of adequate solute removal [ Time Frame: Every three months during one year ]
  • Therapy tolerability [ Time Frame: Every three months during one year ]
Original Secondary Outcome Measures Same as current
Current Other Pre-specified Outcome Measures
 (submitted: June 9, 2015)
Change of therapy modality [ Time Frame: Every three months during one year ]
Original Other Pre-specified Outcome Measures Same as current
 
Descriptive Information
Brief Title PD-Improved Dialysis Efficiency With Adapted APD
Official Title PD-Improved Dialysis Efficiency With Adapted APD - PD-IDEA
Brief Summary The aim of this study is to observe the effect of adapted APD (aAPD) on maintenance and/or improvement of the hydration status of more than 250 PD patients, and to observe the tolerability of the therapy over a long period.
Detailed Description

In some studies it has been observed that the use of a combination of short dwell/small volume and long dwell/large volume can improve the effectiveness of APD. However, these studies have been performed in a small number of patients during a short observation period.

The aim of this study is to assess the hydration status of PD patients treated with aAPD and observe its development during one year using the BCM-Body Composition Monitor (BCM), a bioimpedance spectroscopy (BIS) device. In addition, it is intended to observe the variability of aAPD prescriptions and their influence on the hydration status of the patients.

This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists.

Study Type Observational
Study Design Observational Model: Cohort
Time Perspective: Prospective
Target Follow-Up Duration Not Provided
Biospecimen Not Provided
Sampling Method Non-Probability Sample
Study Population Patients with chronic kidney disease (CKD) being treated or starting renal replacement therapy with aAPD
Condition Chronic Renal Failure
Intervention Other: Treatment with Adapted Automated Peritoneal Dialysis (aAPD)
This is a purely non-interventional, observational study, where treatment decisions are completely guided by the discretion of the attending nephrologists
Study Groups/Cohorts Not Provided
Publications * Not Provided

*   Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline.
 
Recruitment Information
Recruitment Status Completed
Actual Enrollment
 (submitted: August 5, 2020)
182
Original Estimated Enrollment
 (submitted: June 9, 2015)
250
Actual Study Completion Date June 30, 2020
Actual Primary Completion Date June 30, 2020   (Final data collection date for primary outcome measure)
Eligibility Criteria

Inclusion Criteria:

  • CKD patients with indication for renal replacement therapy
  • Patient treated or to be treated with aAPD
  • Fluid status regularly monitored with BCM

Exclusion Criteria:

  • Patients who have any condition prohibiting the use of BCM like patients with major amputations (e.g. lower leg)
  • Participation in an interventional study which could have an effect on the study objectives hydration status and dialysis adequacy (e.g. studies on PD solutions, studies on diuretics)
Sex/Gender
Sexes Eligible for Study: All
Ages 18 Years and older   (Adult, Older Adult)
Accepts Healthy Volunteers No
Contacts Contact information is only displayed when the study is recruiting subjects
Listed Location Countries Czechia,   Denmark,   Finland,   Malaysia,   Spain,   Sweden
Removed Location Countries Czech Republic
 
Administrative Information
NCT Number NCT02470598
Other Study ID Numbers PD-aAPD-01-INT
Has Data Monitoring Committee No
U.S. FDA-regulated Product Not Provided
IPD Sharing Statement Not Provided
Responsible Party Fresenius Medical Care Deutschland GmbH
Study Sponsor Fresenius Medical Care Deutschland GmbH
Collaborators Not Provided
Investigators
Study Director: Michel Fischbach, Prof. University Hospital Hautepierre
Study Director: Manel Vera, Dr. Hospital Clinic i Provinvial de Barcelona
Study Director: Emilio Galli, Dr. Ospedale "Treviglio-Caravaggio" di Treviglio
Study Director: Cecile Courivaud, Dr. University Hospotal Besancon
Study Director: Virpi Rauta, Dr. Helsinki Univerity Hospital
PRS Account Fresenius Medical Care Deutschland GmbH
Verification Date July 2020