Completed

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

0 criteria met from your profileSee at a glance how your profile meets each eligibility criteria.
What is being tested

Standard dose, low flux hemodialysis

+ Standard dose, high flux hemodialysis

+ High dose, low flux hemodialysis

Device
Who is being recruted

Chronic Disease+11

+ Female Urogenital Diseases and Pregnancy Complications

+ Kidney Diseases

From 18 to 80 Years
See all eligibility criteria
How is the trial designed

Treatment Study

Interventional
Study Start: March 1995
See protocol details

Summary

Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: September 14, 2017
Sourced from a government-validated database.Claim as a partner

Study start date: March 1, 1995

Actual date on which the first participant was enrolled.

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.

NCT00004285
Principal SponsorNational Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)
Last updated: September 14, 2017
Sourced from a government-validated database.Claim as a partner

Protocol

This section provides details of the study plan, including how the study is designed and what the study is measuring.
Design Details

1846 patients to be enrolled

Total number of participants that the clinical trial aims to recruit.

Treatment Study

These studies test new ways to treat a disease, condition, or health issue. The goal is to see if a new drug, therapy, or approach works better or has fewer side effects than existing options.



Eligibility

Researchers look for people who fit a certain description, called eligibility criteria: person's general health condition or prior treatments.
Conditions
Criteria

Any sex

Biological sex of participants that are eligible to enroll.

From 18 to 80 Years

Range of ages for which participants are eligible to join.

Healthy volunteers not allowed

If individuals who are healthy and do not have the condition being studied can participate.

Conditions

Pathology

Chronic DiseaseFemale Urogenital Diseases and Pregnancy ComplicationsKidney DiseasesPathologic ProcessesPathological Conditions, Signs and SymptomsUrologic DiseasesDisease AttributesRenal Insufficiency, ChronicRenal InsufficiencyFemale Urogenital DiseasesMale Urogenital DiseasesUrogenital DiseasesKidney Failure, ChronicRare Diseases

Criteria

PROTOCOL ENTRY CRITERIA: --Disease Characteristics-- End stage renal disease that requires in-center hemodialysis 3 times/week On hemodialysis for at least 3 months (6 months following renal transplant) No scheduled renal transplant from living donor --Prior/Concurrent Therapy-- No concurrent intervention studies unless ancillary to this protocol No concurrent investigational drugs --Patient Characteristics-- Hepatic: Albumin at least 2.6 g/dL by nephelometry No cirrhosis with encephalopathy or abnormal PT Renal: Urea clearance (interdialytic) no greater than 1.5 mL/min per 35 liters total urea volume Cardiovascular: No New York Heart Association class IV congestive heart failure despite maximal therapy No unstable angina No new onset angina No recent exacerbation of frequency, duration, or severity of angina Pulmonary: No chronic pulmonary disease requiring supplemental oxygen Other: Not hospitalized in acute or long term care facility at entry No active malignancy requiring chemotherapy or radiotherapy No AIDS No active systemic infection, e.g., tuberculosis or fungal infection No mental incompetence or other contraindication to protocol therapy Not pregnant Geographically available for treatment at participating institution No more than 20 missed treatments/year

Study Plan

Find out more about all the medication administered in this study, their detailed description and what they involve.
Treatment Groups
Study Objectives

4 intervention groups are designated in this study

This study does not include a placebo group 

Treatment Groups

Group I

Active Comparator

Group II

Experimental

Group III

Experimental

Group IV

Experimental

Study Objectives

Primary Objectives

Secondary Objectives

Study Centers

These are the hospitals, clinics, or research facilities where the trial is being conducted. You can find the location closest to you and its status.

This study has 1 location

University of Rochester School of Medicine

Rochester, United StatesOpen University of Rochester School of Medicine in Google Maps
CompletedOne Study Center