Anemia Clinical Trial
Official title:
Single Ascending Dose Study of Intraperitoneal Triferic (Ferric Pyrophosphate Citrate) in Patients on Chronic Peritoneal Dialysis
The main purpose is to determine the pharmacokinetic (PK) profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of Triferic iron administered intraperitoneally in patients with chronic kidney disease on peritoneal dialysis (CKD-5 PD). It is an open label, dose escalation study.
This is a phase 1, open-label, dose escalation study assessing the pharmacokinetic (PK)
profile, maximum concentration (Cmax) and Area Under the Concentration Time Curve (AUC0-t) of
Triferic iron administered intraperitoneally in chronic kidney disease patients on peritoneal
dialysis (Continuous Cycling Peritoneal Dialysis (CCPD) or Continuous Ambulatory Peritoneal
Dialysis (CAPD)).
Screening can be up to 4 weeks, and the enrollment period is approximately one week. There
are two treatment (dosing) visits and one follow-up visit during the enrollment period.
At each treatment visit, the patients will be randomly assigned to receive either a single
ascending dose of Triferic administered intraperitoneal (IP) during a long (12 hour)
peritoneal dialysis dwell or a single 6.6 mg dose of Triferic administered IV over 4 hours.
Blood samples will be obtained at defined times over 12 hours to establish the total serum
iron PK of IP Triferic as well as the clinical serum iron profile.
The IP dose of the first Cohort will be 5 mg Triferic iron/liter IP. Subsequent Cohort IP
doses will be 12.5 mg Triferic iron/liter, and 20 mg Triferic iron/liter, with the final
Cohort dose to be determined (TBD). The IV dose will be 6.6. mg for all Cohorts. Six patients
will be enrolled in each Cohort, with enrollment in the subsequent (higher dose) Cohort not
being initiated until the completion and evaluation of the previous (lower dose) Cohort.
;
| 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 |
NCT02912494 -
A Phase III Study of JR-131 in Renal Anemia Patients With Chronic Kidney Disease (CKD)
|
Phase 3 | |
| Completed |
NCT02930850 -
Spot-Check Noninvasive Hemoglobin (SpHb) Clinical Validation
|
N/A | |
| 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 |
NCT02912533 -
A Long-term 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 | |
| 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 |
NCT01432717 -
Study of ACE-536 in Healthy Postmenopausal Women
|
Phase 1 | |
| Completed |
NCT01458028 -
Age and Gender Effects on the Pharmacokinetics of BAY85-3934
|
Phase 1 |