Status:
COMPLETED
A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Lead Sponsor:
AbbVie (prior sponsor, Abbott)
Conditions:
Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Eligibility:
All Genders
18+ years
Phase:
PHASE4
Brief Summary
To evaluate the effect of PTH lowering on erythropoietin consumption in calcitriol-resistant patients with stage 5 chronic kidney disease.
Eligibility Criteria
Inclusion
- 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
- 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.
Key Trial Info
Start Date :
May 10 2012
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
April 7 2016
Estimated Enrollment :
65 Patients enrolled
Trial Details
Trial ID
NCT01506947
Start Date
May 10 2012
End Date
April 7 2016
Last Update
July 30 2021
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