Kidney Failure, Chronic Clinical Trial
Official title:
Open Randomized Phase IV Study on Intravenous Iron in Anemic Patients With Chronic Kidney Disease
The objective of this study is the evaluation of the efficacy and safety of intravenous iron sucrose in anemic patients with chronic kidney disease not on renal replacement therapy.
This is a randomized, open label, phase IV study in anemic predialysis patients (Hb between 8 and 11.5 g/dl) who require iron supplementation. The duration of the study for each patient will be approximately 6 months. Patients will be randomized to one of two treatment arms and admitted to the anemia correction phase (days 1-43). Treatment will be intravenous iron sucrose alone versus iron sucrose plus rhEPO. The main treatment evaluation will at the end of the correction phase: The primary end-point will be the change of hemoglobin during correction phase. Secondary end-points will be the change of ferritin and transferrin saturation from baseline to day 43. Safety assessments will include recording of adverse events, vital signs, physical examinations and clinical laboratory tests. Incidence and severity of adverse events will be compared between the two different treatment arms. ;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel 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 |
NCT01930396 -
Use of Tinzaparin for Anticoagulation in Hemodialysis
|
Phase 4 | |
| Completed |
NCT01922843 -
A Phase 2 Study of an Oral Vitamin D Compound (DP001) in Secondary Hyperparathyroidism in Patients on Hemodialysis
|
Phase 2 | |
| 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 |