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Frequent Hemodialysis Network: Daily Trial

Primary Purpose

End Stage Renal Disease

Status

Completed

Phase

Phase 2

Locations

United States

Study Type

Interventional

Intervention

Conventional hemodialysis

Frequent hemodialysis

About this trial

This is an interventional treatment trial for End Stage Renal Disease focused on measuring randomized controlled clinical trial, hemodialysis, end stage renal disease

Eligibility Criteria

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

Inclusion Criteria: Patients with end stage renal disease requiring chronic renal replacement therapy Age 13 years or greater Achieved mean eKt/V of > 1.0 on at least two baseline sessions Weight 30 kg or greater Exclusion Criteria: Residual renal urea clearance > 3 mL/min per 35 L. Expectation that native kidneys will recover Vascular access being used for HD is a non-tunneled catheter Inability to come for in-center 6 days a week, including inability to arrange adequate transportation History of poor adherence to thrice weekly HD Medical conditions that would prevent the subject from performing the cardiac MRI procedure (e.g., inability to remain still for the procedure, a metallic object in the body, including cardiac pacemaker, inner ear (cochlear) implant, brain aneurysm clips, mechanical heart valves, recently placed artificial joints, and older vascular stents) Unable to verbally communicate in English or Spanish Requires HD > 3 times per week due to medical co-morbidity (such as, but not limited to: systemic oxalosis, or requiring total parenteral nutrition). Occasional ultrafiltration on a fourth day per week is not an exclusion criterion. Currently on daily or nocturnal HD, or less than 3 months since the subject discontinued daily or nocturnal HD Scheduled for living donor kidney transplant, change to peritoneal dialysis, home HD, or plans to relocate to another center within the next 14 months Expected geographic unavailability at a participating HD unit for > 2 consecutive weeks or > 4 weeks total during the next 14 months (excluding unavailability due to hospitalizations) (frequent HD subjects who leave for vacation may resort back to conventional HD during these time periods) Less than 3 months since the patient returned to HD after acute rejection resulting in allograft failure Currently in acute or chronic care hospital Life expectancy < 6 months A medical history that might limit the subject's ability to take trial treatments for the 12 month duration of the study, including: currently receiving chemo or radiotherapy for a malignant neoplastic disease other than localized non-melanoma skin cancer, active systemic infection (including tuberculosis, disseminated fungal infection, active AIDS but not HIV, and cirrhosis with encephalopathy) Current pregnancy, or actively planning to become pregnant in the next 12 months Contraindication to heparin, including allergy or heparin induced thrombocytopenia Current use of investigational drugs or participation in another clinical trial that contradicts or interferes with the therapies or measured outcomes in this trial Unable or unwilling to follow the study protocol for any reason (including mental incompetence) Unable or unwilling to provide informed consent or sign IRB-approved consent form

Sites / Locations

University of California at San Francisco - Core center plus other centers in California and Texas
Renal Research Institute - Core center plus other centers in U.S. and Canada

Arms of the Study

Arm 1

Arm 2

Arm Type

Active Comparator

Experimental

Arm Label

Conventional hemodialysis

Frequent hemodialysis

Arm Description

Three times per week in-center hemodialysis

Six times per week in-center hemodialysis

Outcomes

Primary Outcome Measures

a composite of mortality with the change over 12 months in left ventricular mass

a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite.

Secondary Outcome Measures

cardiovascular structure and function (change in LV mass)

health-related quality of life/physical function (change in the PHC)

depression/burden of illness (change in Beck Depression Inventory)

nutrition (change in serum albumin)

cognitive function (change in the Trail Making Test B)

mineral metabolism (change in average predialysis serum phosphorus)

clinical events (rate of non-access hospitalization or death)

hypertension

anemia

Full Information

NCT ID

NCT00264758

First Posted

December 12, 2005

Last Updated

July 2, 2014

Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

1. Study Identification

Unique Protocol Identification Number

NCT00264758

Brief Title

Frequent Hemodialysis Network: Daily Trial

Official Title

Frequent Hemodialysis Network: Daily Trial

Study Type

Interventional

2. Study Status

Record Verification Date

July 2014

Overall Recruitment Status

Completed

Study Start Date

January 2006 (undefined)

Primary Completion Date

March 2010 (Actual)

Study Completion Date

March 2010 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title

Sponsor

Name of the Sponsor

National Institute of Diabetes and Digestive and Kidney Diseases (NIDDK)

4. Oversight

Data Monitoring Committee

Yes

5. Study Description

Brief Summary

The Frequent Hemodialysis Network (FHN) Daily Trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada and followed for 1 year. Subjects will be randomized to either conventional hemodialysis Daily HD delivered for at least 2.5 hours (typically 3 to 4 hours), 3 days per week, or to more frequent hemodialysis delivered for 1.5 - 2.75 hours, 6 days per week. The study has two co-primary outcomes: 1) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite (PHC) quality of life scale.

Detailed Description

This trial is a randomized controlled trial recruiting subjects from dialysis units associated with designated Clinical Centers in the U.S. and Canada. A total of 250 ESRD patients receiving in-center HD will be randomized to continue with conventional HD, 3 days per week (control group), or switch to daily HD, 6 days per week (intervention group). Subjects will be treated and followed for 12 months. Two co-primary outcomes are designated: 1) a composite of mortality with the change over 12 months in left ventricular mass, and 2) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite. In addition, main secondary outcomes have been designated for each of seven outcome domains: 1) cardiovascular structure and function (change in LV mass), 2) health-related quality of life/physical function (change in the PHC), 3) depression/burden of illness (change in Beck Depression Inventory), 4) nutrition (change in serum albumin), 5) cognitive function (change in the Trail Making Test B), 6) mineral metabolism (change in average predialysis serum phosphorus), and 7) clinical events (rate of non-access hospitalization or death). Hypertension and anemia are also main outcome domains, but without designation of single first priority outcomes. The objectives of this study are the following: Feasibility: To determine the feasibility of recruiting and retaining patients in a randomized trial of six times per week in-center daily HD versus conventional three times per week in-center HD. To determine patient adherence with and acceptance of in-center daily HD, and to identify reasons for discontinuation from or nonadherence with the therapy. Safety: To determine the safety of in-center daily HD with a particular focus on vascular access events and participant burden. Efficacy: To evaluate the efficacy of in-center daily HD compared to conventional three times per week HD on two co-primary outcomes: i) a composite of mortality with the change over 12 months in left ventricular mass by magnetic resonance imaging (MRI), and ii) a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite score (PHC). To determine the effect of in-center daily HD on nine secondary outcome domains: i) cardiovascular structure and function, ii) health-related quality of life and physical function, iii) depression/burden of illness, iv) nutrition and inflammation, v) cognitive function, vi) mineral metabolism, vii) clinical events, viii) hypertension, and ix) anemia. Characterization of the Intervention To better understand the complex therapy of in-center daily HD, by evaluating solute clearance, treatment times, volume removal, and non-dialytic factors such as differences in the frequency of medical surveillance and treatment. Implementation: To determine the feasibility of implementing in-center daily HD in practice, by evaluating barriers to implementation such as the incremental cost of daily HD compared to 3 times per week conventional HD.

6. Conditions and Keywords

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

End Stage Renal Disease

Keywords

randomized controlled clinical trial, hemodialysis, end stage renal disease

7. Study Design

Primary Purpose

Treatment

Study Phase

Phase 2, Phase 3

Interventional Study Model

Parallel Assignment

Masking

None (Open Label)

Allocation

Randomized

Enrollment

245 (Actual)

8. Arms, Groups, and Interventions

Arm Title

Conventional hemodialysis

Arm Type

Active Comparator

Arm Description

Three times per week in-center hemodialysis

Arm Title

Frequent hemodialysis

Arm Type

Experimental

Arm Description

Six times per week in-center hemodialysis

Intervention Type

Device

Intervention Name(s)

Conventional hemodialysis

Intervention Description

Three times per week in-center hemodialysis

Intervention Type

Device

Intervention Name(s)

Frequent hemodialysis

Intervention Description

Six times per week in-center hemodialysis

Primary Outcome Measure Information:

Title

a composite of mortality with the change over 12 months in left ventricular mass

Time Frame

12 months

Title

a composite of mortality with the change over 12 months in the SF-36 RAND physical health composite.

Time Frame

12 months

Secondary Outcome Measure Information:

Title

cardiovascular structure and function (change in LV mass)

Time Frame

12 months

Title

health-related quality of life/physical function (change in the PHC)

Time Frame

12 months

Title

depression/burden of illness (change in Beck Depression Inventory)

Time Frame

12 months

Title

nutrition (change in serum albumin)

Time Frame

12 months

Title

cognitive function (change in the Trail Making Test B)

Time Frame

12 months

Title

mineral metabolism (change in average predialysis serum phosphorus)

Time Frame

12 months

Title

clinical events (rate of non-access hospitalization or death)

Time Frame

12 months

Title

hypertension

Time Frame

12 months

Title

anemia

Time Frame

12 months

10. Eligibility

Sex

All

Minimum Age & Unit of Time

13 Years

Accepts Healthy Volunteers

Eligibility Criteria

Overall Study Officials: