ESRD Clinical Trial
Official title:
Nutrition, Inflammation and Insulin Resistance in End-Stage Renal Disease
By 2030 an estimated 2 million people in the US will need dialysis or transplantation for
advanced kidney failure. An even more disturbing statistic is that mortality in End Stage
Renal Disease (ESRD) is six times higher than in the general Medicare population with
adjustment for age, gender and ethnicity. Protein energy wasting is highly prevalent in these
patients and is one of the most important determinants of their poor clinical outcome.
Despite its well-recognized occurrence, the etiology and the mechanisms leading to protein
energy wasting observed in chronic hemodialysis patients cannot be attributed to any single
factor. However, irrespective of the specific etiologic mechanisms, it appears that the
common pathway for all the metabolic derangements is related to exaggerated protein
degradation relative to protein synthesis (47).
Two well-recognized and presumably interrelated metabolic abnormalities, insulin resistance
and chronic inflammation, may be the major determinants of protein catabolism in coronary
heart disease (CHD) patients. There are no studies examining the effects of anti-inflammatory
interventions and/or insulin sensitizers on protein homeostasis in CHD. Due to their
established anti-inflammatory and other pleiotropic effects, Interleukin-1 receptor
antagonist Anakinra and insulin sensitizer peroxisome proliferator-activated receptors (PPAR)
agonist Actos represent two such promising interventions. By modulating inflammatory response
and insulin signaling through two pharmacological interventions, the investigators will have
the unique opportunity to clarify mechanisms contributing of these two particular metabolic
derangements in the development of protein energy wasting observed in chronic hemodialysis
patients.
The overall goal is to elucidate the mechanisms by which chronic inflammation and insulin
resistance influence the development of protein energy wasting in hemodialysis patients.
Specific Aim: To test the hypothesis that inhibiting inflammatory response by administration
of an Interleukin1receptor antagonist (Anakinra) or increasing insulin sensitivity by
administration of a PPAR agonist (Actos) will improve net protein metabolism.
Hypothesis: The chronic inflammatory component of protein energy wasting (PEW) observed in
hemodialysis patients is, at least in part, mediated by insulin resistance.
Interim analysis may be performed (no specific plan at this time).
n/a
| 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 |
NCT03943212 -
The Effect of Blood Flow Rate on Dialysis Recovery Time in Patients Undergoing Maintenance Hemodialysis
|
N/A | |
| Completed |
NCT03456648 -
Apixaban in End-stage Kidney Disease : A Pharmacokinetics Study
|
Phase 2 | |
| 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 |
NCT01252771 -
Phosphate Kinetic Modeling 2
|
Phase 4 | |
| Completed |
NCT00850252 -
Use of a Lifeline Graft in the A-V Shunt Model
|
Phase 1/Phase 2 | |
| Completed |
NCT00294502 -
Antibiotic Lock Solutions in the Prevention of Catheter Related Bacteremia
|
Phase 4 | |
| Completed |
NCT05011136 -
Physician Reimbursement Home Patients
|
||
| Completed |
NCT05144971 -
StatStrip A Glucose/Creatinine Meter System Lay User Study Evaluation
|
||
| Completed |
NCT01424787 -
Non-interventional Study to Evaluate the Ease of Reaching Individual Goals in Serum Phosphorus (Steering)
|
N/A | |
| Terminated |
NCT00580762 -
Bariatric Surgery for ESRD Patients vs Control
|
N/A | |
| Recruiting |
NCT05339139 -
SAfety of Regional Citrate Anticoagulation (SARCA Study)
|
Phase 3 | |
| Completed |
NCT03242343 -
VasQ External Support for Arteriovenous Fistula
|
N/A | |
| Recruiting |
NCT05309785 -
Safety and Efficacy of Canagliflozin in Advanced CKD
|
Phase 4 | |
| Completed |
NCT02966028 -
Effect of SNF472 on Progression of Cardiovascular Calcification in End-Stage-Renal-Disease (ESRD) Patients on Hemodialysis (HD)
|
Phase 2 | |
| Completed |
NCT02513303 -
Trial to Evaluate the Sirolimus-Eluting Collagen Implant on AV Fistula Outcomes
|
Phase 3 | |
| Not yet recruiting |
NCT02596386 -
Examination of Potassium Levels in Saliva in ESRD Patients
|
N/A | |
| Active, not recruiting |
NCT02270515 -
Bringing Care to Patients: Patient-Centered Medical Home for Kidney Disease
|
N/A | |
| Recruiting |
NCT06001827 -
SAVE-FistulaS: the SelfWrap-Assisted ArterioVEnous Fistulas Study
|
N/A | |
| Terminated |
NCT03303391 -
Using Intradialytic Blood Pressure Slopes to Guide Ultrafiltration
|
N/A |