A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant
 patients with stage 5 chronic kidney disease.
Inclusion Criteria: A subject will only be included if all the following entry criteria are
 met:

 -  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 serum intact parathyroid hormone (iPTH) level > 500 pg/mL

 -  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

 Exclusion Criteria:

 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.