Anemia Clinical Trial
Official title:
Phase II Clinical Trial to Explore the Optimal Fixed Starting Dose & Dosing Interval and to Evaluate the Safety of GX-E2 in the Anemic Patients Diagnosed With Chronic Kidney Disease and Receiving Hemodialysis (HD) / Peritoneal Dialysis (PD)
The primary objective of study is
- Part A : To explore the optimal fixed starting dose and dosing interval of GX-E2
- Part B : To evaluate the proof of concept (POC) of GX-E2
The secondary objective of study is to evaluate:
- change of red blood cell indices in anemic patients with chronic kidney disease
receiving hemodialysis/peritoneal dialysis when administering GX-E2
intravenously/subcutaneously
- change of reticulocyte indices in anemic patients with chronic kidney disease receiving
hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
- safety of GX-E2 when administering intravenously/subcutaneously
- incidence of blood transfusion in anemic patients with chronic kidney disease receiving
hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
- Immunogenicity in anemic patients with chronic kidney disease receiving
hemodialysis/peritoneal dialysis when administering GX-E2 intravenously/subcutaneously
;
| 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 |
NCT03822884 -
Pharmacokinetic/Pharmacodynamic Study of 3 Subcutaneous Single Dose Epoetin Alfa Formulations in Healthy Volunteers
|
Phase 1 | |
| Completed |
NCT02888171 -
Impact of Ferric Citrate vs Ferrous Sulfate on Iron Parameters and Hemoglobin in Individuals With CKD and Iron Deficiency
|
N/A | |
| 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 |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02603250 -
Evaluation of Hemoglobin Measurement Tools for Child Anemia Screening in Rwanda
|
N/A | |
| Completed |
NCT02384122 -
Efficacy of Octreotide on Blood and Iron Requirements in Patients With Anemia Due to Angiodysplasias
|
Phase 3 | |
| Completed |
NCT02176759 -
Iron Absorption From Rice Fortified With Ferric Pyrophosphate
|
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 |
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 | |
| 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 |