More Frequent Dialysis (>3 Treatments Per Week) (MFD)

April 17, 2019 updated by: Satellite Healthcare

Study of Clinical Outcomes of More Frequent Hemodialysis

The study compares the benefits of short daily hemodialysis six days a week, nocturnal (night time) hemodialysis six days a week, every other day and every other night hemodialysis to traditional three days a week hemodialysis.The hypothesis is that increasing hemodialysis treatment time and/or frequency will improve outcomes.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Actual)

Phase

Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

United States
- California
  - Mountain View, California, United States, 94041
    - WellBound, Inc.
  - Mountain View, California, United States, 64041
    - Satellite Healthcare, Inc.

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

Child
Adult
Older Adult

Accepts Healthy Volunteers

Genders Eligible for Study

All

Description

Inclusion Criteria:

Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
18 years of age.
History of compliance with a dialysis treatment schedule, or if a new patient, express a willingness to be compliant with a treatment schedule.
Plan to continue care and follow-up at the investigational site.
Able to sign the informed consent and other relevant documents.

Exclusion Criteria:

History of poor compliance with thrice (or twice) weekly dialysis schedules as manifested by more than three unexplained missed treatments in the past six (6) months.
Pregnancy.
Intravenous drug abuser.
Expects to receive a transplant or transfer to another facility within six months of entering the study.

Study Plan

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

How is the study designed?

Design Details

Primary Purpose: Treatment
Allocation: Non-Randomized
Interventional Model: Parallel Assignment
Masking: None (Open Label)

Number of Arms

Arms and Interventions

Participant Group / Arm	Intervention / Treatment
Experimental: A Six Day per week short daily hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Experimental: B Six nights per week nocturnal hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Experimental: C Every other day short daily hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Experimental: D Every other night hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Experimental: E 5 days per week short daily hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Experimental: F 5 nights per week hemodialysis	Procedure: More frequent hemodialysis Six Day per week short daily hemodialysis Procedure: More frequent hemodialysis Six nights per week nocturnal hemodialysis Procedure: More frequent hemodialysis Every other day short daily hemodialysis Procedure: More frequent hemodialysis Every other night hemodialysis Procedure: More frequent hemodialysis 5 days per week short daily hemodialysis Procedure: More frequent hemodialysis 5 nights per week hemodialysis
Active Comparator: G Conventional three time per week short daily hemodialysis	Procedure: Conventional Hemodialysis 3 days per week short daily hemodialysis

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Time Frame
Hospitalization days per year Time Frame: Ongoing	Ongoing

Secondary Outcome Measures

Outcome Measure	Time Frame
Nutritional Status measured by Subjective Global Assessment Time Frame: Ongoing	Ongoing
Anemia, measured by erythropoetin dose Time Frame: Ongoing	Ongoing
Control of hypertension, as measured by number of antihypertensive tablets taken per day Time Frame: Ongoing	Ongoing
Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day Time Frame: Ongoing	Ongoing

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Satellite Healthcare

Investigators

Study Director: John Moran, MD, Satellite Healthcare, Inc.
Principal Investigator: Brigittte Schiller-Moran, MD, Satellite Healthcare, Inc.

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

January 1, 2005

Primary Completion (Actual)

August 7, 2012

Study Completion (Actual)

August 7, 2012

Study Registration Dates

First Submitted

December 14, 2007

First Submitted That Met QC Criteria

December 17, 2007

First Posted (Estimate)

December 18, 2007

Study Record Updates

Last Update Posted (Actual)

April 19, 2019

Last Update Submitted That Met QC Criteria

April 17, 2019

Last Verified

April 1, 2019

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

SR002MFD

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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More Frequent Dialysis (>3 Treatments Per Week) (MFD)

Study of Clinical Outcomes of More Frequent Hemodialysis

Study Overview

Status

Conditions

Intervention / Treatment

Study Type

Enrollment (Actual)

Phase

Contacts and Locations

Study Locations

Participation Criteria

Eligibility Criteria

Ages Eligible for Study

Accepts Healthy Volunteers

Genders Eligible for Study

Description

Study Plan

How is the study designed?

Design Details

Number of Arms

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

What is the study measuring?

Primary Outcome Measures

Outcome Measure

Time Frame

Secondary Outcome Measures

Outcome Measure

Time Frame

Collaborators and Investigators

Sponsor

Investigators

Study record dates

Study Major Dates

Study Start

Primary Completion (Actual)

Study Completion (Actual)

Study Registration Dates

First Submitted

First Submitted That Met QC Criteria

First Posted (Estimate)

Study Record Updates

Last Update Posted (Actual)

Last Update Submitted That Met QC Criteria

Last Verified

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

Clinical Trials on End Stage Renal Disease

Clinical Trials on More frequent hemodialysis

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