Paricalcitol Improves Anemia of Inflammation (PIERAID)

August 22, 2022 updated by: Miguel Giovanni Uriol Rivera, Hospital Son Espases

Benefits of the Paricalcitol (Selective Vitamin D Receptor Activator) on Anemia of Inflammation in Dialysis Patients Under Erythropoiesis-stimulating Agents Treatment.

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.

Study Overview

Status

Recruiting

Conditions

Intervention / Treatment

Detailed Description

Anemia of inflammation and secondary hyperparathyroidism (SHPT) are two common clinical complications in patients with chronic kidney disease. Eryptosis (accelerated red blood cell death) is a novel mechanism associated with renal anemia and several factors such us iron, erythropoietin and klotho (anti-aging hormone) deficiency have been associated with this process.

The use of the paricalcitol may inhibit pro-inflammatory cytokines expression, especially interleukine-6, which is one of the most important cytokine associated with the pathogenesis of the AI. If the use of the paricalcitol for the SHPT control may exert direct influence on the erythropoiesis process is not known.

Study Type

Interventional

Enrollment (Anticipated)

46

Phase

  • Phase 4

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Locations

  • Spain
    • Islas Baleares
      • Palma de Mallorca, Islas Baleares, Spain, 07120
        • Recruiting
        • Son Espases University Hospital
        • Contact:
        • Sub-Investigator:
          • Sheila Cabello Pelegrin, MD
        • Sub-Investigator:
          • Juan Rey Valeriano, MD
        • Sub-Investigator:
          • Antonio Corral Paez, MD
        • Sub-Investigator:
          • Angel Garcia Alvarez, Pharmacist
        • Sub-Investigator:
          • Sonia Jimenez Mendoza, MD
        • Sub-Investigator:
          • Manuel Luque_Ramírez, Ph.D.MD.
        • Principal Investigator:
          • Miguel Uriol Rivera, Ph.D.MD.
        • Sub-Investigator:
          • Aina Obrador Mulet, MD

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years and older (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

Inclusion Criteria:

  • 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.
  • Hemoglobin plasma levels stabilized: Hb variation <or = 1 g / dl for the two months prior to inclusion 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.
  • Patients who accept their inclusion in the study and sign informed consent.

Exclusion Criteria:

  • 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.
  • Patients treated with the selective vitamin D receptor activator in the 3 months prior to inclusion in the study.
  • 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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Experimental: paricalcitol plus epoetin beta
Paricalcitol 2 capsules /three times per week & epoetin
Drug: Paricalcitol
Paricalcitol 2 capsules/three times per week
Other Names:
  • Selective vitamin D receptor activation
Drug: Epoetin beta
epoetin 1-3 times per week
Other Names:
  • anti-anemic drug
Placebo Comparator: placebo plus epoetin beta
Placebo 2 capsules/three times per week & epoetin
Drug: Epoetin beta
epoetin 1-3 times per week
Other Names:
  • anti-anemic drug
Drug: Placebo
Placebo 2 capsules/three times per week

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes in ESA dosage
Time Frame: 6 months
Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.
6 months

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Changes on ferrokinetics.
Time Frame: 6 months
Changes on serum iron, transferrin, ferritin, transferrin saturation and red cell distribution width at month 6.
6 months
Changes on interleukin-6 plasma levels.
Time Frame: 6 months
Changes on pg/ml
6 months
Changes on hepcidin plasma levels.
Time Frame: 6 months
Changes on pg/ml
6 months
Changes on erythropoietin plasma levels.
Time Frame: 6 months
Changes on mUI/ml
6 months
Changes on systolic blood pressure.
Time Frame: 6 months
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
6 months
Changes on diastolic blood pressure.
Time Frame: 6 months
Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.
6 months
Cardiovascular serious adverse events in each arm of treatment.
Time Frame: 6 months
Cardiac arrest, angina pectoris. Stroke.
6 months
Adverse events related to vascular access disfunction.
Time Frame: 6 month
Arteriovenous fistula site hemorrhage or thrombosis. Catheter disfunction.
6 month

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Hospital Son Espases

Investigators

  • Principal Investigator: Miguel Uriol, Ph.D.M.D., Son Espases University Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Actual)

December 1, 2014

Primary Completion (Actual)

August 1, 2022

Study Completion (Anticipated)

December 1, 2024

Study Registration Dates

First Submitted

August 12, 2016

First Submitted That Met QC Criteria

August 17, 2016

First Posted (Estimate)

August 23, 2016

Study Record Updates

Last Update Posted (Actual)

August 24, 2022

Last Update Submitted That Met QC Criteria

August 22, 2022

Last Verified

August 1, 2022

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • PIERAID-2013

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

YES

IPD Plan Description

The IPD could be shared with any interested public research institute

IPD Sharing Time Frame

After finalized the study

IPD Sharing Access Criteria

Research

IPD Sharing Supporting Information Type

  • STUDY_PROTOCOL
  • SAP
  • ICF

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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