Clareo Health | A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Saves the questions and what to expect into your notes, next to the visit they belong to.
Keep this study
Lead
AbbVie (prior sponsor, Abbott)
Age
18–any
Sex
ALL
Healthy volunteers
Not accepted
You may be eligible if
Patients ≥ 18 years of age
Stage 5 chronic kidney disease (CKD) patients receiving hemodialysis and with moderate to severe secondary hyperparathyroidism (SHPT)
Patients with anemia due to renal insufficiency but who are iron replete:; Transferrin saturation (TSAT) \> 20% and Ferritin levels \> 200 ng/mL and requiring treatment with erythropoietin (EPO)
Patients with vitamin B levels \> lower limit of normal (LLN) and folic acid levels \> LLN
Patients treated only with intravenous calcitriol for at least 6 months
Patients with calcium phosphate product (Ca × PO4) \< 65 mg²/dL²
Patients willing to sign "written informed consents" before participating in any the study related activity.
Patients with phosphorus levels \< 6.5 mg/dL and calcium levels \< 11.2 mg/dL
You may not be if
A subject will be excluded from the study if he/she meets any of the following criteria:
Patients who have known hypersensitivity and/or toxicity to vitamin D metabolites and/or to paricalcitol and/or to other product ingredients.
Patients who have participated in a clinical study within the last month.
Patients whose previous concomitant medication and laboratory data for 6 months prior to the baseline visit are not available.
Patients with known contraindication to selective Vitamin D receptor activators (VDRAs) according to the Summary of Product Characteristics (SmPC).
Pregnancy, breast-feeding or planning a pregnancy within next 6 months after enrollment. Sexually active female patients not accepting appropriate contraceptive methods during the course of the study will also be excluded.
Hypertensive and diabetic patients who are not on an optimal and steady medication regimen for more than 30 days.
Patients with microcytic (mean corpuscular volume \[MCV\] \< 80 fL) and macrocytic (MCV \> 100 fL) anemia at screening that may be caused by diseases such as for microcytic anemias - Iron Deficiency, Thalassemias, Anemia of Chronic Disease, Copper Deficiency, Zinc poisoning, Sideroblastic Anemia, macrocytic anemias -ethanol abuse, myelodysplastic syndromes, acute myeloid leukemias, reticulocytosis, drug induced anemia, liver disease.
