Clinical trial NCT01506947: A Pilot Clinical Study Evaluating the Effect of Parathyroid Hormone (PTH) Lowering On Erythropoietin Consumption in Calcitriol-Resistant Patients
Official title: A Prospective, Non-randomised, Single-arm, Open-Label Pilot Clinical Study Evaluating the Effect of PTH Lowering on Erythropoietin Consumption in Calcitriol-Resistant Patients
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Moderate to Severe Secondary Hyperparathyroidism
Stage 5 Chronic Kidney Diseases
Keywords: Hemodialysis
Chronic kidney disease
Secondary hyperparathyroidism,
Lead sponsor: AbbVie
Sponsor class: INDUSTRY
First posted: 2012-01-10
Enrollment: 65
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: NA
Intervention model: SINGLE_GROUP
Primary purpose: TREATMENT

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 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.

Primary outcomes:
measure: Mean Erythropoietin Dose Per Visit
timeFrame: Baseline and Months 1, 2, 3, 4, 5 and 6
Secondary outcomes:
measure: Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire
timeFrame: Baseline and Month 6
measure: Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Mean Calcium Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Mean Phosphorus Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Mean Alkaline Phosphatase Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Vitamin B12 Levels
timeFrame: Baseline and month 6
measure: Folic Acid Levels
timeFrame: Baseline and month 6
measure: Mean High Sensitivity C-reactive Protein (hsCRP) Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Mean Fibroblast Growth Factor-23 (FGF-23) Level at Baseline and Month 6
timeFrame: Baseline and Month 6
measure: Number of Participants With Adverse Events
timeFrame: From the time of study drug administration until 4 weeks after the discontinuation of the study drug; up to 7 months.
Other outcomes:
Locations:
Study officials:
affiliation: AbbVie
name: Mahmut Gücük, MD
role: STUDY_DIRECTOR
References:
citation: Poordad F, Landis CS, Asatryan A, Jackson DF 3rd, Ng TI, Fu B, Lin CW, Yao B, Kort J. High antiviral activity of NS5A inhibitor ABT-530 with paritaprevir/ritonavir and ribavirin against hepatitis C virus genotype 3 infection. Liver Int. 2016 Aug;36(8):1125-32. doi: 10.1111/liv.13067. Epub 2016 Feb 3.