Anemia Clinical Trial
Official title:
A Randomized, Double-Blind, Placebo Controlled Pilot Trial of Oral Salsalate in the Treatment of the Subset of Unexplained Anemia in Elderly Patients With Elevated Interleukin-6
The purpose of this study is to determine whether treatment of unexplained anemia in older adults and elevated inflammatory markers with oral salsalate can improve hemoglobin levels and improve physical activity and quality of life.
There is well-defined morbidity and mortality associated with anemia in the elderly and the
increasing proportion of elderly adults underscores the population's attributable risk of
anemia. As a potentially modifiable factor, an urgent need exists to delineate the impact of
anemia correction in the elderly. The Partnership for Anemia: Clinical and Translational
Trials in the Elderly (PACTTE) consortium has been created to focus on treatment strategies
for anemia in elderly patients. The data presented in this protocol provides a compelling
rationale to evaluate the impact of an anti-inflammatory (Salsalate) in older anemic adults
with elevated serum iL-6 levels.
Subjects will be 65 years or older adults with unexplained anemia and a elevated serum iL-6
≥ 1.0 pg/mL.
Subjects will receive 750mg of salsalate or matching placebo (one pill) twice a day (am and
pm) for one month. After one month the dose will be increased to 1500mg (2 pills) twice a
day (am and pm) if the 750mg dose was tolerated for a further 5 months (for a total of 6
months)
The primary endpoint is to assess whether salsalate improves hemoglobin levels from baseline
to 6 month visit.
;
Allocation: Randomized, Endpoint Classification: Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Caregiver, Investigator, Outcomes Assessor), 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 |
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 |
NCT02912533 -
A Long-term 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 |
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 | |
| Withdrawn |
NCT01934842 -
A Study to Compare Analyte Levels in Blood Collected Using an Investigational Collection Device With a Commercial Predicate
|
N/A | |
| Completed |
NCT02310113 -
Transfusion and Skeletal Muscle Tissue Oxygenation
|
N/A | |
| Completed |
NCT01922479 -
Pilot Study of Ferric Carboxymaltose to Treat Iron Deficiency in Asians With Heart Failure
|
Phase 4 | |
| 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 | |
| Terminated |
NCT01535781 -
Study of the Effect of Tranexamic Acid Administered to Patients With Hip Fractures. Can Blood Loss be Reduced?
|
N/A |