NCT00575497

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
46

participants targeted

Target at P25-P50 for not_applicable

Timeline
Completed

Started Jan 2005

Longer than P75 for not_applicable

Geographic Reach
1 country

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

January 1, 2005

Completed
3 years until next milestone

First Submitted

Initial submission to the registry

December 14, 2007

Completed
4 days until next milestone

First Posted

Study publicly available on registry

December 18, 2007

Completed
4.6 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

August 7, 2012

Completed
Same day until next milestone

Study Completion

Last participant's last visit for all outcomes

August 7, 2012

Completed
Last Updated

April 19, 2019

Status Verified

April 1, 2019

Enrollment Period

7.6 years

First QC Date

December 14, 2007

Last Update Submit

April 17, 2019

Conditions

Keywords

HemodialysisAdequacyFrequency

Outcome Measures

Primary Outcomes (1)

  • Hospitalization days per year

    Ongoing

Secondary Outcomes (4)

  • Nutritional Status measured by Subjective Global Assessment

    Ongoing

  • Anemia, measured by erythropoetin dose

    Ongoing

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

    Ongoing

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

    Ongoing

Study Arms (7)

A

EXPERIMENTAL

Six Day per week short daily hemodialysis

Procedure: More frequent hemodialysis

B

EXPERIMENTAL

Six nights per week nocturnal hemodialysis

Procedure: More frequent hemodialysis

C

EXPERIMENTAL

Every other day short daily hemodialysis

Procedure: More frequent hemodialysis

D

EXPERIMENTAL

Every other night hemodialysis

Procedure: More frequent hemodialysis

E

EXPERIMENTAL

5 days per week short daily hemodialysis

Procedure: More frequent hemodialysis

F

EXPERIMENTAL

5 nights per week hemodialysis

Procedure: More frequent hemodialysis

G

ACTIVE COMPARATOR

Conventional three time per week short daily hemodialysis

Procedure: Conventional Hemodialysis

Interventions

Six Day per week short daily hemodialysis

A

3 days per week short daily hemodialysis

G

Eligibility Criteria

Sexall
Healthy VolunteersNo
Age GroupsChild (0-17), Adult (18-64), Older Adult (65+)

You may qualify if:

  • Stable vascular access, i.e., lack of needling difficulties and stable flow rates. Accesses will include fistulae, grafts, catheters and ports.
  • 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.

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Satellite Healthcare, Inc.

Mountain View, California, 64041, United States

Location

WellBound, Inc.

Mountain View, California, 94041, United States

Location

MeSH Terms

Conditions

Kidney Failure, ChronicRenal Insufficiency, Chronic

Condition Hierarchy (Ancestors)

Renal InsufficiencyKidney DiseasesUrologic DiseasesFemale Urogenital DiseasesFemale Urogenital Diseases and Pregnancy ComplicationsUrogenital DiseasesMale Urogenital DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Study Officials

  • John Moran, MD

    Satellite Healthcare, Inc.

    STUDY DIRECTOR
  • Brigittte Schiller-Moran, MD

    Satellite Healthcare, Inc.

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NON RANDOMIZED
Masking
NONE
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 14, 2007

First Posted

December 18, 2007

Study Start

January 1, 2005

Primary Completion

August 7, 2012

Study Completion

August 7, 2012

Last Updated

April 19, 2019

Record last verified: 2019-04

Locations