Artegraft Versus Propaten Dialysis Grafts

Status Terminated

Clinical Trial Summary

Compare Artegraft and Propaten grafts for use in dialysis access to see if one performs better than the other. How long each one lasts until a complication arises or until the graft is no longer used will be compared.

The study hypothesis is that the Artegraft, being an actual blood vessel, will work better than the manufactured Propaten graft.

Clinical Trial Description

Approximately 50 eligible patients with End Stage Renal Disease (ESRD) requiring hemodialysis will be randomized to receive one of these two grafts as part of their standard care. Patients will be assessed at 2-3 weeks post-operatively and again at 6 and 12 months for flow characteristics, dialysis adequacy and graft associated complications such as stenosis, infection and thrombosis. Data on urea reduction ratio (URR), kinetic modeling (Kt/V), and access flow (QB) will be collected at 3, 6, 9 and 12 months via phone call to the hemodialysis center in order to evaluate patency and function.

Access complications (stenosis, thrombosis, infection) will be treated per our standard protocol. These data will be recorded and then primary, assisted primary and secondary patency rates will be calculated and the graft arms compared using life table analysis. ;

Study Design

Related Conditions & MeSH terms

Clinical Trial Details

NCT number	NCT02099344
Study type	Interventional
Source	Kaiser Permanente
Contact
Status	Terminated
Phase	Phase 4
Start date	April 2014
Completion date	November 2014

View Details

See also
Status	Clinical Trial	Phase
Completed	`NCT02763410` - Impact of the Composition of Packed Red Blood Cell Supernatant on Renal Dysfunction and Posttransfusion Immunomodulation
Active, not recruiting	`NCT03183245` - Comparison of the Human Acellular Vessel (HAV) With Fistulas as Conduits for Hemodialysis	Phase 3
Completed	`NCT04084301` - Impact of Cardiopulmonary Bypass Flow on Renal Oxygenation, Blood Flow and Tubular Injury	N/A
Completed	`NCT03292029` - Pilot Medical Evaluation of the T50 Test	N/A
Suspended	`NCT04589065` - SCD for CRS in Congestive Heart Failure (CHF) (No Left Ventricular Assist Device)	N/A
Completed	`NCT03806998` - Effects of a Ketoacid Supplementation in Patients With Stage III to IV Renal Failure	Phase 3
Active, not recruiting	`NCT03672110` - Slow and Low Start of a Tacrolimus Once Daily Immunosuppressive Regimen	Phase 3
Completed	`NCT02325726` - RRI Compared With NephroCheckTM to Predict Acute Renal Failure After Cardiac Surgery.	N/A
Completed	`NCT02116270` - Accelerated Immunosenescence and Chronic Kidney Disease	N/A
Completed	`NCT01859273` - Adherence Enhancement for Renal Transplant Patients	N/A
Completed	`NCT01388270` - Effect of a Pre Heparin Coated Dialysis Filter on Coagulation During Hemodialysis	Phase 4
Completed	`NCT01187953` - Double-Blind,Double-Dummy,Efficacy/Safety,LCP-Tacro™ Vs Prograf®,Prevention Rejection,De Novo Adult Kidney Tx	Phase 3
Completed	`NCT01476995` - Prognostic Indicators as Provided by the EPIC ClearView	N/A
Completed	`NCT00966615` - The Effect of Neutral Peritoneal Dialysis (PD) Solution With Minimal Glucose-Degradation-Product (GDP) on Fluid Status and Body Composition	Phase 4
Completed	`NCT01008631` - The Pharmacologic Profile of Sodium Thiosulfate in Renal Failure and Healthy Volunteers	N/A
Completed	`NCT00737672` - GORE VIABAHN Endoprosthesis Versus Percutaneous Transluminal Angioplasty (PTA) to Revise AV Grafts in Hemodialysis	Phase 3
Completed	`NCT00765661` - Pharmacokinetics of LCP-Tacro(TM) Once Daily And Prograf® Twice A Day in Adult De Novo Kidney Transplant Patients	Phase 2
Completed	`NCT00808691` - Microcirculation and Oxidative Stress in Critical Ill Patients in Surgical Intensive Care Unit	N/A
Recruiting	`NCT00470769` - The Efficacy of Color-Doppler Ultrasonography to Assess the Renal Blood Flow With the Estimation of GFR	N/A
Terminated	`NCT00338455` - Natrecor (Nesiritide) in Transplant-Eligible Management of Congestive Heart Failure-TMAC	Phase 2