NCT00004285

Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 1,846 (actual)
• Sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) · NIH
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Not accepted

Summary

OBJECTIVES: I. Evaluate whether hemodialysis providing a 2-pool, variable volume urea kinetic modelling value of 1.05 versus 1.45 reduces mortality and morbidity in patients with end stage renal disease. II. Compare the efficacy of high versus low flux dialyzer membranes.

Detailed description

PROTOCOL OUTLINE: This is a randomized, multicenter study. Patients are stratified by center, age, and diabetes prior to dialysis initiation. Patients are randomly assigned to 1 of 4 groups: moderate dose dialysis, low flux membrane; high dose dialysis, low flux membrane; moderate dose dialysis, high flux membrane; or high dose dialysis, high flux membrane. Moderate dose is a target eKt/V of 1.05 and high dose is 1.45. The dose and delivery of dialysis are measured monthly by the equilibrated fractional clearance of urea (eKt/V) calculated with double pool kinetics. Patients are dialyzed 3 times a week in the shortest possible time (minimum 2.5 hours), adjusted for adequate fluid removal. General medical care, protein and calorie intake, and dialyzer reuse and other aspects of dialysis therapy are standardized. The protocol document lists approved dialyzers; no unsubstituted cellulosic membranes are permitted. The intervention phase of this study is 5 years. Patients are followed for survival.

Conditions

• End Stage Renal Disease

Interventions

Type	Name	Description
DEVICE	Standard dose, low flux hemodialysis
DEVICE	Standard dose, high flux hemodialysis
DEVICE	High dose, low flux hemodialysis
DEVICE	High dose, high flux hemodialysis

Timeline

• Start date: 1995-03-01
• Primary completion: 2001-12-31
• Completion: 2001-12-31
• First posted: 1999-10-19
• Last updated: 2017-09-14

Locations

1 site across 1 country: United States

Regulatory

• FDA-regulated device study