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

NCT01506947 | Completed Phase 4 Results

• 1 other identifier: W12-645
• Study Type: interventional
• Target: 65
• Locations: 0 countries
• Sites: N/A

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

Keywords

Hemodialysis; Chronic kidney disease; Secondary hyperparathyroidism,

Outcome Measures

Primary Outcomes (1)

• Mean Erythropoietin Dose Per Visit

  The requirement of erythropoietin (EPO) treatment to maintain serum hemoglobin levels between 10 to 11.5 g/dL during the study was assessed by analysis of the dose of darbepoetin alfa used at baseline and during each month of the study. The mean EPO dosage per injection for each study month is reported.

  Baseline and Months 1, 2, 3, 4, 5 and 6

Secondary Outcomes (10)

• Mean Scores of Short Form Health Survey 36 (SF-36) Questionnaire

  Baseline and Month 6

• Mean Intact Parathyroid Hormone (iPTH) Level at Baseline and Month 6

  Baseline and Month 6

• Mean Calcium Level at Baseline and Month 6

  Baseline and Month 6

• Mean Phosphorus Level at Baseline and Month 6

  Baseline and Month 6

• Mean Alkaline Phosphatase Level at Baseline and Month 6

  Baseline and Month 6

Study Arms (1)

Paricalcitol

EXPERIMENTAL

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.

Drug: Paricalcitol; Drug: Darbepoetin alfa

Interventions

Paricalcitol 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.

Also known as: ABT-358, Zemplar

Paricalcitol

Darbepoetin alfa 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.

Paricalcitol

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• AbbVie (prior sponsor, Abbott): lead

Related Publications (1)

• 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.

  PMID: 26778412 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Renal Insufficiency, Chronic; Hyperparathyroidism, Secondary

Interventions

paricalcitol; Darbepoetin alfa

Condition Hierarchy (Ancestors)

Renal Insufficiency; Kidney Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms; Hyperparathyroidism; Parathyroid Diseases; Endocrine System Diseases

Intervention Hierarchy (Ancestors)

Erythropoietin; Colony-Stimulating Factors; Glycoproteins; Glycoconjugates; Carbohydrates; Proteins; Amino Acids, Peptides, and Proteins

Results Point of Contact

• Title: Global Medical Services
• Organization: AbbVie (prior sponsor Abbott)

800-633-9110

Study Officials

• Mahmut Gücük, MD

  AbbVie

  STUDY DIRECTOR

Publication Agreements

• PI is Sponsor Employee: No
• Restriction Type: OTHER
• Restrictive Agreement: Yes

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 28, 2011
• First Posted: January 10, 2012
• Study Start: May 10, 2012
• Primary Completion: April 7, 2016
• Study Completion: April 7, 2016
• Last Updated: July 30, 2021
• Results First Posted: May 15, 2017

Record last verified: 2021-07