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

NCT ID: NCT01506947

Last Updated: 2021-07-30

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: PHASE4
• Total Enrollment: 65 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2012-05-10
• Study Completion Date: 2016-04-07

Brief Summary

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

Conditions

Moderate to Severe Secondary Hyperparathyroidism; Stage 5 Chronic Kidney Diseases

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Primary Study Purpose: TREATMENT
• Blinding Strategy: NONE

Study Groups

Paricalcitol

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.

Group Type: EXPERIMENTAL

Paricalcitol

Intervention Type: DRUG

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.

Darbepoetin alfa

Intervention Type: DRUG

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.

Interventions

Paricalcitol

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.

Intervention Type: DRUG

Darbepoetin alfa

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 Type: DRUG

Other Intervention Names

ABT-358; Zemplar

Eligibility Criteria

Inclusion Criteria

• 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.

• Minimum Eligible Age: 18 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

AbbVie (prior sponsor, Abbott)

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Mahmut Gücük, MD

Role: STUDY_DIRECTOR

AbbVie

References

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.

Reference Type: BACKGROUND

PMID: 26778412 (View on PubMed)

Related Links

http://rxabbvie.com

Related Info

Other Identifiers

W12-645

Identifier Type: -

Identifier Source: org_study_id