Anemia Clinical Trial
The aim of this study is to explore and identify the effects of acetylcysteine, a common mucolytic with anti-oxidant property, on alleviating the damage caused by increased oxidative stress in hemodialysis patients.
Oxidative stress in patients with renal failure is higher than in healthy controls. Once
undergoing hemodialysis (HD) therapy, patients with end-stage renal disease even have more
oxidative stress. Reactive oxygen species (ROS) denature the vital molecules, such as
lipids, proteins, and nucleic acids.
Increased ROS produce oxidized low-density lipoproteins (ox-LDL), which, in turn, induce
atherosclerosis and subsequent cardiovascular disease. Cardiovascular disease is the leading
cause of death of HD patients. On the other hand, ROS damage RBC membrane and cause
hemolysis. Hemolysis exaggerates uremic anemia and results in resistance to erythropoietin
(EPO) therapy.
Acetylcysteine, a common mucolytic, is an antioxidant as well. In vivo experiments,
acetylcysteine has been demonstrated to inhibit the production of ox-LDL by ROS.
Acetylcysteine has also been shown as an effective drug for prevention of contrast
media-induced nephropathy in high-risk patients.
Thus we hypothesize HD patients taking acetylcysteine may have less ox-LDL produced by ROS
and, consequently, lower risk of cardiovascular disease. Moreover, having less damage to RBC
membrane by ROS, HD patients taking acetylcysteine may have milder anemia and better
responsiveness to erythropoietin therapy. Therefore, we plan to conduct a prospective trial,
in which acetylcysteine is administrated to the enrolled HD patients for three months. The
primary goals of the study are to realize the changes of 1) plasma ox-LDL levels, 2) the
anemia status, 3) the responsiveness to EPO therapy, and 4) severity of atherosclerosis. The
secondary goals are to identify the changes of oxidative stress and pro-inflammatory status
in the patients.
;
Allocation: Non-Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Single Group Assignment, Masking: Open Label, Primary Purpose: Treatment
| Status | Clinical Trial | Phase | |
|---|---|---|---|
| Terminated |
NCT00801931 -
Double Cord Blood Transplant for Patients With Malignant and Non-malignant Disorders
|
Phase 1/Phase 2 | |
| Completed |
NCT02948283 -
Metformin Hydrochloride and Ritonavir in Treating Patients With Relapsed or Refractory Multiple Myeloma or Chronic Lymphocytic Leukemia
|
Phase 1 | |
| Completed |
NCT03341338 -
Genes-in-Action - Hepcidin Regulation of Iron Supplementation
|
||
| Completed |
NCT00060398 -
Epoetin Alfa With or Without Dexamethasone in Treating Fatigue and Anemia in Patients With Hormone-Refractory Prostate Cancer
|
Phase 3 | |
| Recruiting |
NCT05384691 -
Efficacy of Luspatercept in ESA-naive LR-MDS Patients With or Without Ring Sideroblasts Who do Not Require Transfusions
|
Phase 2 | |
| Not yet recruiting |
NCT06309641 -
Methemoglobinemia Following Intravenous Iron Treatment
|
||
| Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
| Completed |
NCT02912533 -
A Long-term Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| Completed |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
| Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
| Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
N/A | |
| Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
| Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
| Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
| Completed |
NCT01693029 -
Study to Compare Safety and Efficacy of HX575 Epoetin Alfa and US-licensed Epoetin Alfa
|
Phase 3 | |
| Completed |
NCT01458028 -
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
|
Phase 1 | |
| Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A |