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

Primary Purpose

End Stage Renal Disease, Chronic Kidney Disease

Status

Completed

Phase

Not Applicable

Locations

United States

Study Type

Interventional

Intervention

More frequent hemodialysis

Conventional Hemodialysis

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring Hemodialysis, Adequacy, Frequency

Eligibility Criteria

undefined - undefined (Child, Adult, Older Adult)All SexesDoes not accept healthy volunteers

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.

Sites / Locations

Satellite Healthcare, Inc.
WellBound, Inc.

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm 4

Arm 5

Arm 6

Arm 7

Arm Type

Experimental

Active Comparator

Arm Label

Arm Description

Six Day per week short daily hemodialysis

Six nights per week nocturnal hemodialysis

Every other day short daily hemodialysis

Every other night hemodialysis

5 days per week short daily hemodialysis

5 nights per week hemodialysis

Conventional three time per week short daily hemodialysis

Outcomes

Primary Outcome Measures

Hospitalization days per year

Secondary Outcome Measures

Nutritional Status measured by Subjective Global Assessment

Anemia, measured by erythropoetin dose

Control of hypertension, as measured by number of antihypertensive tablets taken per day

Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day

Full Information

NCT ID

NCT00575497

First Posted

December 14, 2007

Last Updated

April 17, 2019

Sponsor

Satellite Healthcare

1. Study Identification

Unique Protocol Identification Number

NCT00575497

Brief Title

More Frequent Dialysis (>3 Treatments Per Week)

Acronym

MFD

Official Title

Study of Clinical Outcomes of More Frequent Hemodialysis

Study Type

Interventional

2. Study Status

Record Verification Date

April 2019

Overall Recruitment Status

Completed

Study Start Date

January 2005 (undefined)

Primary Completion Date

August 7, 2012 (Actual)

Study Completion Date

August 7, 2012 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

Satellite Healthcare

4. Oversight

Data Monitoring Committee

5. Study Description

Brief Summary

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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study

End Stage Renal Disease, Chronic Kidney Disease

Keywords

Hemodialysis, Adequacy, Frequency

7. Study Design

Primary Purpose

Treatment

Study Phase

Not Applicable

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Non-Randomized

Enrollment

46 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Arm Type

Experimental

Arm Description

Six Day per week short daily hemodialysis

Arm Title

Arm Type

Experimental

Arm Description

Six nights per week nocturnal hemodialysis

Arm Title

Arm Type

Experimental

Arm Description

Every other day short daily hemodialysis

Arm Title

Arm Type

Experimental

Arm Description

Every other night hemodialysis

Arm Title

Arm Type

Experimental

Arm Description

5 days per week short daily hemodialysis

Arm Title

Arm Type

Experimental

Arm Description

5 nights per week hemodialysis

Arm Title

Arm Type

Active Comparator

Arm Description

Conventional three time per week short daily hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

Six Day per week short daily hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

Six nights per week nocturnal hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

Every other day short daily hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

Every other night hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

5 days per week short daily hemodialysis

Intervention Type

Procedure

Intervention Name(s)

More frequent hemodialysis

Intervention Description

5 nights per week hemodialysis

Intervention Type

Procedure

Intervention Name(s)

Conventional Hemodialysis

Intervention Description

3 days per week short daily hemodialysis

Primary Outcome Measure Information:

Title

Hospitalization days per year

Time Frame

Ongoing

Secondary Outcome Measure Information:

Title

Nutritional Status measured by Subjective Global Assessment

Time Frame

Ongoing

Title

Anemia, measured by erythropoetin dose

Time Frame

Ongoing

Title

Control of hypertension, as measured by number of antihypertensive tablets taken per day

Time Frame

Ongoing

Title

Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day

Time Frame

Ongoing

10. Eligibility

Sex

All

Accepts Healthy Volunteers

Eligibility Criteria

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.

Overall Study Officials:

First Name & Middle Initial & Last Name & Degree

John Moran, MD

Organizational Affiliation

Satellite Healthcare, Inc.

Official's Role

Study Director

First Name & Middle Initial & Last Name & Degree

Brigittte Schiller-Moran, MD

Organizational Affiliation

Satellite Healthcare, Inc.

Official's Role

Principal Investigator

Facility Information:

Facility Name

Satellite Healthcare, Inc.

City

Mountain View

State/Province

California

ZIP/Postal Code

64041

Country

United States

Facility Name

WellBound, Inc.

City

Mountain View

State/Province

California

ZIP/Postal Code

94041

Country

United States

12. IPD Sharing Statement

Learn more about this trial

More Frequent Dialysis (>3 Treatments Per Week)

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