Paricalcitol Improves Anemia of Inflammation

NCT02876211 | Terminated Phase 4 DMC

• 1 other identifier: PIERAID-2013
• Study Type: interventional
• Target: 19
• Locations: 1 country
• Sites: 1

Brief Summary

Anemia of inflammation (AI) is a common comorbidity in hemodialysis patients. Paricalcitol is a selective vitamin D receptor activator with potential benefits on anti-inflammatory cytokines expression. The paricalcitol for the secondary hyperparathyroidism control may improve AI decreasing erythropoietin stimulating agents (ESAs) dosage.

Conditions

Anemia

Keywords

Renal disease; Erythropoiesis; Erythropoietin stimulating agent; Iron; Klotho; Selective vitamin D receptor activation

Outcome Measures

Primary Outcomes (1)

• Changes in ESA dosage

  Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.

  6 months

Secondary Outcomes (8)

• Changes on ferrokinetics.

  6 months

• Changes on interleukin-6 plasma levels.

  6 months

• Changes on hepcidin plasma levels.

  6 months

• Changes on erythropoietin plasma levels.

  6 months

• Changes on systolic blood pressure.

  6 months

Study Arms (2)

paricalcitol plus epoetin beta

EXPERIMENTAL

Paricalcitol 2 capsules /three times per week \& epoetin

Drug: Paricalcitol; Drug: Epoetin beta

placebo plus epoetin beta

PLACEBO COMPARATOR

Placebo 2 capsules/three times per week \& epoetin

Drug: Epoetin beta; Drug: Placebo

Interventions

Paricalcitol DRUG

Paricalcitol 2 capsules/three times per week

Also known as: Selective vitamin D receptor activation

paricalcitol plus epoetin beta

Epoetin beta DRUG

epoetin 1-3 times per week

Also known as: anti-anemic drug

paricalcitol plus epoetin beta; placebo plus epoetin beta

Placebo DRUG

Placebo 2 capsules/three times per week

placebo plus epoetin beta

Eligibility Criteria

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

You may qualify if:

• Age \>= 18 years.
• Patients with CKD on hemodialysis of any etiology..
• Hemoglobin between 9 and 12g/dl at least 12 weeks before enrollment in the study.
• Patients with anemia of renal etiology.
• ESA treatment with stable doses for 2 months prior to baseline.Stable dose ESA Definition: Variation \<or = 3000UI/week.
• Iron status: Ferritin\> 200 ng / mL and/or transferrin saturation index (IST):\> = 20%).
• KT / V \>= 1.2 ( Daugirdas-2nd generation).
• Calcium concentrations between : 8.4 to 9.5 mg / dl and phosphorus: 3.5-5.5 mg / dl.
• Vitamin D 25OH normal \>= 15 ng / ml (patients with lower levels will be supplemented with calcifediol 16000 IU / bi-weekly for 6 weeks in selected patients).
• PTHi concentrations\> = 150 pg / mL and \<or = to 300 pg / ml.

You may not qualify if:

• Epoetin beta dose \> 18,000 IU / weekly.
• Pregnant woman of childbearing age or gestational wishes or not to use adequate contraception ( the Ogino-Knaus contraceptive method is considered unsuitable).
• Active bleeding episode or history of transfusion the 2 months prior to baseline.
• Patients with non-renal causes of anemia: malignancies, folic acid or vitamin B12 deficiency, hemoglobinopathies, hemolysis, pure red cell aplasia secondary to erythropoietin.
• Acute or chronic symptomatic: heart failure (IV-NYHA), infection or inflammatory disease, uncontrolled hypertension that requires the suspension of epoetin beta, thrombocytopathies, aplastic anemia.
• Immunosuppressive treatment with uncontrolled Hemoglobin level
• Allergy to paricalcitol or any of its components.

Sponsors & Collaborators

• Hospital Son Espases: lead

Study Sites (1)

Son Espases University Hospital

Palma de Mallorca, Balearic Islands, 07120, Spain

Location

Related Publications (3)

• Sun CC, Vaja V, Babitt JL, Lin HY. Targeting the hepcidin-ferroportin axis to develop new treatment strategies for anemia of chronic disease and anemia of inflammation. Am J Hematol. 2012 Apr;87(4):392-400. doi: 10.1002/ajh.23110. Epub 2012 Jan 31.

  PMID: 22290531 BACKGROUND

• Perlstein TS, Pande R, Berliner N, Vanasse GJ. Prevalence of 25-hydroxyvitamin D deficiency in subgroups of elderly persons with anemia: association with anemia of inflammation. Blood. 2011 Mar 10;117(10):2800-6. doi: 10.1182/blood-2010-09-309708. Epub 2011 Jan 14.

  PMID: 21239700 BACKGROUND

• Kempe DS, Ackermann TF, Fischer SS, Koka S, Boini KM, Mahmud H, Foller M, Rosenblatt KP, Kuro-O M, Lang F. Accelerated suicidal erythrocyte death in Klotho-deficient mice. Pflugers Arch. 2009 Jul;458(3):503-12. doi: 10.1007/s00424-009-0636-4. Epub 2009 Jan 28.

  PMID: 19184092 BACKGROUND

MeSH Terms

Conditions

Anemia; Kidney Diseases

Interventions

paricalcitol; epoetin beta

Condition Hierarchy (Ancestors)

Hematologic Diseases; Hemic and Lymphatic Diseases; Urologic Diseases; Female Urogenital Diseases; Female Urogenital Diseases and Pregnancy Complications; Urogenital Diseases; Male Urogenital Diseases

Study Officials

• Miguel Uriol, Ph.D.M.D.

  Son Espases University Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Ph.D. MD.

Study Record Dates

• First Submitted: August 12, 2016
• First Posted: August 23, 2016
• Study Start: December 1, 2014
• Primary Completion: August 1, 2022
• Study Completion: December 1, 2024
• Last Updated: December 9, 2024

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF
• Time Frame: After finalized the study
• Access Criteria: Research

Locations

ES (1)