A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients

AbbVie

Status and phase: Completed; Phase 4

Conditions: Stage 5 Chronic Kidney Diseases; Moderate to Severe Secondary Hyperparathyroidism

Treatments: Drug: Paricalcitol; Drug: Darbepoetin alfa

Study type: Interventional

Funder types: Industry

Identifiers

NCT01506947

W12-645

Details and patient eligibility

About

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

Enrollment: 65 patients

Sex: All

Ages: 18+ years old

Volunteers: No Healthy Volunteers

Inclusion and exclusion 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.

Trial design

Primary purpose: Treatment

Allocation: N/A

Interventional model: Single Group Assignment

Masking: None (Open label)

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65 participants in 1 patient group

Paricalcitol

Experimental group

Description:

Participants received paricalcitol intravenously during hemodialysis until serum intact parathyroid hormone (iPTH) levels were below 150 pg/mL or for up to 6 months. Paricalcitol dose was based on iPTH levels and was titrated to maintain iPTH levels between 150-300 pg/mL. Participants may have also received routine darbepoetin alfa to treat anemia.

Treatment:

Drug: Paricalcitol

Drug: Darbepoetin alfa