More Frequent Dialysis (>3 Treatments Per Week)

NCT ID: NCT00575497

Last Updated: 2019-04-19

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

COMPLETED

Clinical Phase

NA

Total Enrollment

46 participants

Study Classification

INTERVENTIONAL

Study Start Date

2005-01-31

Study Completion Date

2012-08-07

Brief Summary

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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.

Detailed Description

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Conditions

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End Stage Renal Disease Chronic Kidney Disease

Study Design

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Allocation Method

NON_RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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A

Six Day per week short daily hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

Six Day per week short daily hemodialysis

B

Six nights per week nocturnal hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

Six nights per week nocturnal hemodialysis

C

Every other day short daily hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

Every other day short daily hemodialysis

D

Every other night hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

Every other night hemodialysis

E

5 days per week short daily hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

5 days per week short daily hemodialysis

F

5 nights per week hemodialysis

Group Type EXPERIMENTAL

More frequent hemodialysis

Intervention Type PROCEDURE

5 nights per week hemodialysis

G

Conventional three time per week short daily hemodialysis

Group Type ACTIVE_COMPARATOR

Conventional Hemodialysis

Intervention Type PROCEDURE

3 days per week short daily hemodialysis

Interventions

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More frequent hemodialysis

Six Day per week short daily hemodialysis

Intervention Type PROCEDURE

More frequent hemodialysis

Six nights per week nocturnal hemodialysis

Intervention Type PROCEDURE

More frequent hemodialysis

Every other day short daily hemodialysis

Intervention Type PROCEDURE

More frequent hemodialysis

Every other night hemodialysis

Intervention Type PROCEDURE

More frequent hemodialysis

5 days per week short daily hemodialysis

Intervention Type PROCEDURE

More frequent hemodialysis

5 nights per week hemodialysis

Intervention Type PROCEDURE

Conventional Hemodialysis

3 days per week short daily hemodialysis

Intervention Type PROCEDURE

Eligibility Criteria

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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.
Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Satellite Healthcare

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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John Moran, MD

Role: STUDY_DIRECTOR

Satellite Healthcare, Inc.

Brigittte Schiller-Moran, MD

Role: PRINCIPAL_INVESTIGATOR

Satellite Healthcare, Inc.

Locations

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Satellite Healthcare, Inc.

Mountain View, California, United States

Site Status

WellBound, Inc.

Mountain View, California, United States

Site Status

Countries

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United States

Other Identifiers

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SR002MFD

Identifier Type: -

Identifier Source: org_study_id

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