More Frequent Dialysis (>3 Treatments Per Week)

Chronic Kidney Disease Clinical Trial

— MFD  

Official title:

Study of Clinical Outcomes of More Frequent Hemodialysis

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT00575497
• Other study ID #: SR002MFD
• Status: Completed
• Phase: N/A
• Start date: January 2005
• Est. completion date: August 7, 2012

Study information

• Verified date: April 2019
• Source: Satellite Healthcare
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 46
• Est. completion date: August 7, 2012
• Est. primary completion date: August 7, 2012
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

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.

Related Conditions & MeSH terms

• Chronic Kidney Disease
• End Stage Renal Disease
• Kidney Diseases
• Kidney Failure, Chronic
• Renal Insufficiency, Chronic

Intervention

Procedure:
• More frequent hemodialysis
Six Day per week short daily hemodialysis
• More frequent hemodialysis
Six nights per week nocturnal hemodialysis
• More frequent hemodialysis
Every other day short daily hemodialysis
• More frequent hemodialysis
Every other night hemodialysis
• More frequent hemodialysis
5 days per week short daily hemodialysis
• More frequent hemodialysis
5 nights per week hemodialysis
• Conventional Hemodialysis
3 days per week short daily hemodialysis

Locations

Country	Name	City	State
United States	Satellite Healthcare, Inc.	Mountain View	California
United States	WellBound, Inc.	Mountain View	California

Sponsors (1)

Lead Sponsor	Collaborator
Satellite Healthcare

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Hospitalization days per year		Ongoing
Secondary	Nutritional Status measured by Subjective Global Assessment		Ongoing
Secondary	Anemia, measured by erythropoetin dose		Ongoing
Secondary	Control of hypertension, as measured by number of antihypertensive tablets taken per day		Ongoing
Secondary	Control of hyperphosphatemia, as measured by number of phosphate binder tablets taken per day		Ongoing