Increasing the Removal of Protein-Bound Solutes During Extended Hours Hemodialysis

Hemodialysis keeps patients with renal failure alive but does not restore normal health. Retention of chemicals that bind to plasma proteins and are therefore poorly removed by dialysis may contribute to ill health in patients receiving conventional treatment. This proposal will test the effect of a new method designed to improve the removal of protein-bound solutes during dialysis. The effects on blood chemical levels of two different dialysis prescriptions will be tested in patients already undergoing nocturnal in-center hemodialysis three times weekly.

Study Overview

• Status: Unknown
• Conditions: End Stage Renal Failure on Dialysis
• Intervention / Treatment: Other: high dialysate flow, larger dialyzer; Other: low dialysate flow, smaller dialyzer

• Study Type: Interventional
• Enrollment (Anticipated): 24
• Phase: Not Applicable

Contacts and Locations

Study Locations

• United States
  • California
    • Redwood City, California, United States, 94063
      • Recruiting
      • Satellite Redwood City
      • Contact: Tim Meyer, MD; Phone Number: 650-852-3314; Email: twmeyer@stanford.edu
      • Contact: Orlando Camacho, MD; Phone Number: 650-852-3314; Email: orlandoc@stanford.edu
    • Stanford, California, United States, 94301
      • Recruiting
      • Stanford University
      • Contact: Orlando Camacho, MD; Phone Number: 650-852-3314; Email: orlandoc@stanford.edu
      • Contact: Timothy Meyer, MD; Phone Number: 650-852-3314; Email: twmeyer@stanford.edu
      • Principal Investigator: timothy w meyer, md

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: 18 years to 85 years (Adult, Older Adult)
• Accepts Healthy Volunteers: No
• Genders Eligible for Study: All

Description

Inclusion Criteria:

• stable on nocturnal in-center dialysis located close to Stanford University and VA Palo Alto

Exclusion Criteria:

• recent use of antibiotics
• gastrointestinal disease

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Basic Science
• Allocation: Randomized
• Interventional Model: Crossover Assignment
• Masking: None (Open Label)

Number of Arms

2

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: high dialysate flow, larger dialyzer	Other: high dialysate flow, larger dialyzer; The subject will receive dialysis on the usual schedule and for the usual time but with a higher than usual dialysate flow and large dialyzer.
Active Comparator: low dialysate flow, smaller dialyzer	Other: low dialysate flow, smaller dialyzer; The subject will receive dialysis on the usual schedule and for the usual time but with a lower than usual dialysate flow and small dialyzer.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Plasma levels of the chemical p-cresol sulfate	Participants will be followed for 2-3 weeks on different dialysis prescriptions and plasma chemical levels will be measured at the end of this period.

Collaborators and Investigators

• Sponsor: Palo Alto Veterans Institute for Research
• Investigators: Principal Investigator: Timothy W Meyer, MD, PAIRE

Study record dates

Study Major Dates

• Study Start: July 1, 2013
• Primary Completion (Anticipated): December 1, 2015
• Study Completion (Anticipated): December 1, 2016

Study Registration Dates

• First Submitted: June 27, 2013
• First Submitted That Met QC Criteria: July 1, 2013
• First Posted (Estimate): July 4, 2013

Study Record Updates

• Last Update Posted (Estimate): July 13, 2015
• Last Update Submitted That Met QC Criteria: July 9, 2015
• Last Verified: July 1, 2015

More Information

Terms related to this study

• Additional Relevant MeSH Terms: Kidney Diseases; Urologic Diseases; Renal Insufficiency; Renal Insufficiency, Chronic; Kidney Failure, Chronic; Pharmaceutical Solutions; Dialysis Solutions
• Other Study ID Numbers: MEY0026APR

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No