End Stage Renal DiseaseHEMONCT00004285

Effect of Dialysis Dose and Membrane Flux in Maintenance Hemodialysis

A study testing Standard dose, low flux hemodialysis, Standard dose, high flux hemodialysis and High dose, low flux hemodialysis in people with End Stage Renal Disease, run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK) at 1 site in United States.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record

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Trial 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. Read more about this study

Who is it for?: Ages 18 to 80 years
Conditions the study is for: End Stage Renal Disease
What is being tested?: Standard dose, low flux hemodialysis, Standard dose, high flux hemodialysis and High dose, low flux hemodialysis
Type of treatment: Medical device
Could I receive a placebo?: No, everyone receives an active treatment
How many people: 1,846 participants
Where: 1 siteUnited States
Study dates: Mar 1995to 31 Dec 2001
Phase: Interventional
Are there results?: None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

Ages 18 to 80 years
All sexes
No healthy volunteers
Adult, Older adult

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

Trial locations and contacts

1 site in 1 country.

United States1 site

University of Rochester School of Medicine
Rochester, New York, 14642

Other trials in United States

About this study

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

II. Compare the efficacy of high versus low flux dialyzer membranes.

Read the 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
Being tested: Standard dose, low flux hemodialysis, Standard dose, high flux hemodialysis, High dose, low flux hemodialysis, High dose, high flux hemodialysis
Keywords: end stage renal disease, rare disease, renal and genitourinary disorders
Medical subject headings: Kidney Failure, Chronic, Rare Diseases, Urogenital Diseases

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

Standard dose, low flux hemodialysisDevice
Standard dose, high flux hemodialysisDevice
High dose, low flux hemodialysisDevice
High dose, high flux hemodialysisDevice

Study groups in NCT00004285
Study group	Role	What they receive
Standard dose, low flux hemodialysis	Active comparator	Not described Receives: Device: Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis	Experimental	Not described Receives: Device: Standard dose, high flux hemodialysis
High dose, low flux hemodialysis	Experimental	Not described Receives: Device: High dose, low flux hemodialysis
High dose, high flux hemodialysis	Experimental	Not described Receives: Device: High dose, high flux hemodialysis

What is being measured

The primary outcome is the main question the study is designed to answer.

Death from any cause
Measured: 5 years

Secondary outcomes (8)

First hospitalization for cardiac causes or death from any cause
Measured: 5 years
First hospitalization for infection or death from any cause
Measured: 5 years
First >15% decrease in albumin or death from any cause
Measured: 5 years
All hospitalizations not related to vascular access
Measured: 5 years
Death due to cardiac causes
Measured: 5 years
First hospitalization or death due to cardiac causes
Measured: 5 years
Death due to infection
Measured: 5 years
First hospitalization or death due to infection
Measured: 5 years

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

Mar 199531 Dec 2001

First posted19 Oct 1999 (estimated)
Study startMar 1995
Primary completion31 Dec 2001
Study completion31 Dec 2001

Resources

Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
Publications (2)Papers the sponsor has linked to this study.
Other trials for End Stage Renal DiseaseStudies of the same condition, open and under way.
More trials run by National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)The sponsor's other registered studies.
What the trial phases meanHow a treatment moves from first tests in people to approval.

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design

Study type: Interventional
Phase: Phase N/A
Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Enrolment: 1,846 participants (actual)

IDs, dates and publications

ClinicalTrials.gov ID: NCT00004285
Sponsor's protocol ID: 199/11704
Other IDs: U01DK046109, U01DK046114, U01DK046126, U01DK046140, U01DK046143, U01DK049240, U01DK049241, U01DK049242
Acronym: HEMO
Status last verified: Sep 2017
First submitted: 18 Oct 1999
Last updated: 14 Sep 2017
Results posted: No
Data monitoring committee: Yes
FDA-regulated drug: No
FDA-regulated device: Yes
Individual data sharing: Yes: Data and samples are available at the NIDDK central repository

Publications

Greene T, Beck GJ, Gassman JJ, Gotch FA, Kusek JW, Levey AS, Levin NW, Schulman G, Eknoyan G. Design and statistical issues of the hemodialysis (HEMO) study. Control Clin Trials. 2000 Oct;21(5):502-25. doi: 10.1016/s0197-2456(00)00062-3.
PubMed 11018567
Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
PubMed 12490682

Want to know more?

The sponsor has not listed a contact. The official record may have more details.

Talk to your doctor first and take this page with you. Only the study team can confirm whether you can join.

Questions to ask the study team

What is the study trying to find out?
What would I need to do, and how often would I visit?
Could I receive a placebo instead of the treatment?
What are the possible risks and benefits for me?
Will it cost me anything? Are travel or time paid for?
Can I keep seeing my own doctor during the study?
What happens when the study ends?

See locations

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Physical Impairments in Children With Chronic Renal Failure
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A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
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All End Stage Renal Disease trials

Study at a glance

From the registry record, last updated by the sponsor on 14 Sep 2017. Recruitment status is as the sponsor reported it: confirm with the study team.

Official title: Randomized Study of Standard vs High Amount of Hemodialysis Using Low vs High Flux Dialyzer Membranes for End Stage Renal Disease
ClinicalTrials.gov ID: NCT00004285
Acronym / sponsor ID: HEMO / 199/11704
Conditions: End Stage Renal Disease
Keywords: end stage renal disease, rare disease, renal and genitourinary disorders
Study type: Interventional
Recruitment status: Completed
Enrolment: 1,846 participants (actual)
Lead sponsor: National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)US National Institutes of Health
Collaborators: University of Rochester, The Cleveland Clinic, Tufts Medical Center, Vanderbilt University, Icahn School of Medicine at Mount Sinai, Lundquist Institute for Biomedical Innovation at Harbor-UCLA Medical Center, Washington University School of Medicine, University of Illinois Chicago, Main Line Health, Emory University, Duke University, University of Texas Southwestern Medical Center, Brigham and Women's Hospital, Wake Forest University Health Sciences, University of Utah, University of California, Davis, University of Alabama at Birmingham
Study start: Mar 1995 (actual)
Primary completion: 31 Dec 2001 (actual)
Study completion: 31 Dec 2001 (actual)
First posted: 19 Oct 1999 (estimated)
Results: Not posted in the source record

Clinical summary

The research question as the sponsor registered it. This describes what the study plans to test, not what it found.

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.

The intervention phase of this study is 5 years. Patients are followed for survival.

Study design

Primary purpose: Treatment
Allocation: Randomised
Intervention model: Factorial
Masking: None (open label)
Number of arms: 4

Arm	Type	Receives
Standard dose, low flux hemodialysis	Active comparator	Device: Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis	Experimental	Device: Standard dose, high flux hemodialysis
High dose, low flux hemodialysis	Experimental	Device: High dose, low flux hemodialysis
High dose, high flux hemodialysis	Experimental	Device: High dose, high flux hemodialysis

Who may qualify

Ages: 18 to 80 years
Sex: All
Healthy volunteers: Not accepted
Age groups: Adult, Older adult

Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.

Interventions

Intervention	Type	Arms
Standard dose, low flux hemodialysis	Device	Standard dose, low flux hemodialysis
Standard dose, high flux hemodialysis	Device	Standard dose, high flux hemodialysis
High dose, low flux hemodialysis	Device	High dose, low flux hemodialysis
High dose, high flux hemodialysis	Device	High dose, high flux hemodialysis

Primary outcome

Death from any cause
Time frame: 5 years

8 secondary outcomes

First hospitalization for cardiac causes or death from any cause
Time frame: 5 years
First hospitalization for infection or death from any cause
Time frame: 5 years
First >15% decrease in albumin or death from any cause
Time frame: 5 years
All hospitalizations not related to vascular access
Time frame: 5 years
Death due to cardiac causes
Time frame: 5 years
First hospitalization or death due to cardiac causes
Time frame: 5 years
Death due to infection
Time frame: 5 years
First hospitalization or death due to infection
Time frame: 5 years

Results and safety

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

Research links

Official record on ClinicalTrials.govLast updated by the sponsor 14 Sep 2017.
Background: PubMed 11018567Greene T, Beck GJ, Gassman JJ, Gotch FA, Kusek JW, Levey AS, Levin NW, Schulman G, Eknoyan G. Design and statistical issues of the hemodialysis (HEMO) study. Control Clin Trials. 2000 Oct;21(5):502-25. doi: 10.1016/s0197-2456(00)00062-3.
Results publication: PubMed 12490682Eknoyan G, Beck GJ, Cheung AK, Daugirdas JT, Greene T, Kusek JW, Allon M, Bailey J, Delmez JA, Depner TA, Dwyer JT, Levey AS, Levin NW, Milford E, Ornt DB, Rocco MV, Schulman G, Schwab SJ, Teehan BP, Toto R; Hemodialysis (HEMO) Study Group. Effect of dialysis dose and membrane flux in maintenance hemodialysis. N Engl J Med. 2002 Dec 19;347(25):2010-9. doi: 10.1056/NEJMoa021583.
Individual participant dataSharing planned: Yes. Data and samples are available at the NIDDK central repository

Related trials for End Stage Renal Disease

Active, not recruitingPhase 2
Safety and Efficacy of Empagliflozin in Hemodialysis
End Stage Renal Disease
Not yet recruiting
Hypothermic Kidney Machine Perfusion With Omnisol
End Stage Renal Disease (ESRD), Kidney Transplant
Recruiting
Guiding Optimal Blood Pressure Management in Peritoneal Dialysis Pilot Trial
End Stage Kidney Disease (ESKD), Hypertension (HTN)
RecruitingObservational study
Physical Impairments in Children With Chronic Renal Failure
Chronic Kidney Failure, Chronic Kidney Diseases
RecruitingPhase 1
A Study to Test the Safety of the Study Drug Fosmanogepix and How the Body Handles It in Adults With Severe Kidney Failure on Dialysis
End Stage Renal Disease on Dialysis, Adult

Referral and contact

AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.

Daniel B. Ornt study chair

University of Rochester

1 site in 1 country: see every site and its status.

Questions about this trial

What is this clinical trial studying?

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 14 Sep 2017. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 1 site in United States. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

Death from any cause (time frame: 5 years). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT00004285, which also lists 2 linked publications.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 Sep 2017.