Overview

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

Status:
Completed
Trial end date:
2016-04-07
Target enrollment:
0
Participant gender:
All
Summary
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
Phase:
Phase 4
Accepts Healthy Volunteers?
No
Details
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Treatments:
Calcitriol
Darbepoetin alfa
Epoetin Alfa
Ergocalciferols
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.