Kidney Failure, Chronic Clinical Trial
Official title:
Comparison of Nocturnal Hemodialysis (NHD) and Short Daily Hemodialysis (DHD) With the NxStage® System One™
The purpose of this study is to determine whether or not nocturnal hemodialysis is equivalent to short daily hemodialysis on a per treatment basis, using the NxStage System One in the home setting.
End Stage Renal Disease (ESRD) continues to be a devastating clinical condition. The number
of patients in 2004 affected by ESRD in the United States rose to 472,000. More than 104,000
new patients began therapy for ESRD in 2004 (1.5% greater than in 2003), while the prevalent
dialysis population reached nearly 336,000 (3.4% higher). Total Medicare costs for ESRD in
2004 rose to $20.1 billion while non-Medicare costs rose to $12.4 Billion(1).
Treatment options for ESRD patients are currently limited to either transplantation or
dialysis. As daily hemodialysis (DHD) continues to gain widespread acceptance in the
dialysis community, there is also renewed interest in nocturnal hemodialysis (NHD) therapy.
NHD has the potential to provide certain advantages over both DHD and conventional
thrice-weekly in-center HD. NHD typically consists of 6 - 10 hour treatments while the
patient sleeps, providing more gentle fluid removal, more time for equilibration, improved
hemodynamic stability and superior clearance of larger solutes(2).
The proposed study plans to explore whether or not NHD is equivalent to DHD on a per
treatment basis, using the NxStage System One in the home setting.
1. United States Renal Data System 2006 Annual Data Report: Atlas of End-Stage Renal
Disease in the United States, NIH, NIDDK, Bethesda, MD, 2006
2. Lacson E, Diaz-Buxo J: Daily and Nocturnal Hemodialysis: How do they stack up? American
Journal Kidney Disease, Vol 38(2) Aug 2001: 225-239.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Crossover Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Completed |
NCT03246984 -
VALUE- Vascular Access Laminate eUropean Experience. A Post Market Surveillance Study to Assess the Safety and Effectiveness of VasQ
|
N/A | |
| Completed |
NCT02922361 -
Spending and Outcomes for Complex Medicare Advantage Patients
|
||
| Completed |
NCT02235571 -
iChoose Decision Kidney Aid for End-Stage Renal Disease Patients
|
N/A | |
| Completed |
NCT01933789 -
Improving Communication About Serious Illness
|
N/A | |
| Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
| Completed |
NCT01930396 -
Use of Tinzaparin for Anticoagulation in Hemodialysis
|
Phase 4 | |
| Not yet recruiting |
NCT01674660 -
Factors Associated With Interdialytic Blood Pressure Variability in Maintenance Hemodialysis Patients
|
N/A | |
| Not yet recruiting |
NCT01157260 -
The Effects of AST-120 on Endothelial Dysfunction in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT01209403 -
Insulin-like Growth Factor (IGF-I) in Hemodialysis Patients
|
Phase 4 | |
| Completed |
NCT00753116 -
Renal Denervation in End Stage Renal Disease Patients With Refractory Hypertension
|
Phase 1 | |
| Recruiting |
NCT00532688 -
N-Acetylcysteine in Heart Failure With Coexistent Chronic Renal Failure
|
Phase 2/Phase 3 | |
| Completed |
NCT00528788 -
How Vitamin D Analogues Affect Endothelial Cells in Patients on Dialysis
|
Phase 4 | |
| Completed |
NCT00534144 -
Comparison Between Effects of Two Iron Preparations on Protein in the Urine
|
Phase 1 | |
| Completed |
NCT00226902 -
Vascular Reactivity in Kidney Disease Patients
|
N/A | |
| Completed |
NCT00382044 -
Audit of the Effect of Changing From IV to SC Administration of ESA's in Haemodialysis Patients
|
N/A | |
| Recruiting |
NCT00235287 -
Pulse Wave Velocity, Pulse Wave Morphology and Blocking of the Reninangiotensin System in Patients With Chronic Kidney Disease
|
Phase 4 | |
| Completed |
NCT00224081 -
DRIVE Trial (Dialysis Patients' Response to Intravenous [IV] Iron With Elevated Ferritin)
|
Phase 4 | |
| Completed |
NCT00071214 -
Study to Evaluate the Effectiveness of StaphVAX in Adults on Hemodialysis
|
Phase 3 | |
| Completed |
NCT00049907 -
Cardiac and Renal Disease Study (CARDS)
|
N/A | |
| Completed |
NCT00006297 -
Risk Factors for CV Disease in a Dialysis Cohort
|
N/A |