Peritoneal Dialysis Versus Haemodialysis

This study is currently recruiting participants.
Verified February 2013 by University Hospital, Ghent
Sponsor:
Information provided by (Responsible Party):
University Hospital, Ghent
ClinicalTrials.gov Identifier:
NCT00752583
First received: September 12, 2008
Last updated: February 1, 2013
Last verified: February 2013
  Purpose

Study in order to quantify toxin removal during dialysis


Condition Intervention
Hemodialysis
Procedure: Peritoneal dialysis
Procedure: Haemodialysis

Study Type: Interventional
Study Design: Allocation: Randomized
Endpoint Classification: Efficacy Study
Intervention Model: Crossover Assignment
Masking: Open Label
Primary Purpose: Treatment
Official Title: Clinical Study in Order to Quantify Solute Removal in Peritoneal Dialysis Versus Haemodialysis

Resource links provided by NLM:


Further study details as provided by University Hospital, Ghent:

Primary Outcome Measures:
  • Registration of toxin removal efficiency [ Time Frame: After 1 week and after 1, 3, 6, 9, 12, 18 and 24 months ] [ Designated as safety issue: No ]

Estimated Enrollment: 75
Study Start Date: September 2008
Estimated Study Completion Date: December 2013
Estimated Primary Completion Date: May 2013 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 1
Peritoneal dialysis
Procedure: Peritoneal dialysis
Blood, urine and dialysate sampling
Active Comparator: 2
Haemodialysis
Procedure: Haemodialysis
Blood, urine and dialysate sampling

  Eligibility

Ages Eligible for Study:   18 Years and older
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   No
Criteria

Inclusion Criteria:

  • Substudy 1: includes new starting dialysis patients on peritoneal dialysis PD or haemodialysis HD
  • Substudy 2: stabile haemodialysis patients and peritoneal dialysis patients. Patients will be matched for gender, time on dialysis, diabetes, renal function at the start of dialysis.
  • Substudy 3: patients on CAPD (continuous ambulant PD) or CCPD (continuous cyclic PD).
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT00752583

Contacts
Contact: Sunny Eloot, PhD Sunny.eloot@ugent.be

Locations
Belgium
University Hospital Ghent Recruiting
Ghent, Belgium, 9000
Principal Investigator: Raymond Vanholder, MD, PhD         
Sub-Investigator: Sunny Eloot, PhD         
Sponsors and Collaborators
University Hospital, Ghent
Investigators
Principal Investigator: Raymond Vanholder, MD, PhD University Hospital, Ghent
  More Information

Additional Information:
No publications provided

Responsible Party: University Hospital, Ghent
ClinicalTrials.gov Identifier: NCT00752583     History of Changes
Other Study ID Numbers: 2008/232
Study First Received: September 12, 2008
Last Updated: February 1, 2013
Health Authority: Belgium: Institutional Review Board

Keywords provided by University Hospital, Ghent:
Chronic renal insufficiency (patients under dialysis)

ClinicalTrials.gov processed this record on April 16, 2014