A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Condition: Moderate to Severe Secondary Hyperparathyroidism; Stage 5 Chronic Kidney Diseases
MeSH terms: Kidney Diseases; Renal Insufficiency, Chronic; Hyperparathyroidism; Hyperparathyroidism, Secondary
Intervention: Paricalcitol; Darbepoetin alfa
Intervention description: Paricalcitol was administered by intravenous bolus. The initial dose was calculated according to the following formula:
[Paricalcitol (µg) = iPTH (pg/mL) / 80]. Subsequent doses were determined based on iPTH, calcium and phosphorus levels.; Routine darbepoetin alfa use was allowed when transferrin saturation (TSAT) was ≥ 20% and ferritin ≥ 200 μg/L, and hemoglobin level < 11.5 g/dL. The initial dose was 0.25 to 0.75 µg/kg/week, and the maintenance dose was 0.13 to 0.35 µg/kg/week. Target hemoglobin level was between 10 to 11.5 g/dL.
Intervention MeSH terms: Darbepoetin alfa
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Intervention model: Single Group Assignment
Masking: None (Open Label)
Enrollment: 65.0
Sex: All
Minimum age: 18 Years
Healthy volunteers: No
Keywords: Hemodialysis; Chronic kidney disease; Secondary hyperparathyroidism,

Summary:

      To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant
      patients with stage 5 chronic kidney disease.
    

Eligibility criteria:

        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.