Peritoneal Dialysis Versus Haemodialysis

This study is currently recruiting participants. (see Contacts and Locations)
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

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 October 29, 2014