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Trial record 1 of 1 for:    Paricalcitol Improves Anemia of Inflammation
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Paricalcitol Improves Anemia of Inflammation (PIERAID)

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ClinicalTrials.gov Identifier: NCT02876211
Recruitment Status : Recruiting
First Posted : August 23, 2016
Last Update Posted : September 17, 2018
Sponsor:
Information provided by (Responsible Party):
Miguel Giovanni Uriol Rivera, Hospital Son Espases

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.

Condition or disease Intervention/treatment Phase
Anemia Drug: Paricalcitol Drug: Epoetin beta Drug: Placebo Phase 4

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.


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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 46 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: Double (Participant, Investigator)
Primary Purpose: Treatment
Official Title: Benefits of the Paricalcitol (Selective Vitamin D Receptor Activator) on Anemia of Inflammation in Dialysis Patients Under Erythropoiesis-stimulating Agents Treatment.
Study Start Date : December 2014
Estimated Primary Completion Date : July 2019
Estimated Study Completion Date : December 2019

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Anemia Vitamin D

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 Name: Selective vitamin D receptor activation

Drug: Epoetin beta
epoetin 1-3 times per week
Other Name: 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 Name: anti-anemic drug

Drug: Placebo
Placebo 2 capsules/three times per week




Primary Outcome Measures :
  1. Changes in ESA dosage [ Time Frame: 6 months ]
    Percentage of ESA doses after 6 months of the paricalcitol or placebo administration.


Secondary Outcome Measures :
  1. Changes on ferrokinetics. [ Time Frame: 6 months ]
    Changes on serum iron, transferrin, ferritin, transferrin saturation and red cell distribution width at month 6.

  2. Changes on interleukin-6 plasma levels. [ Time Frame: 6 months ]
  3. Changes on hepcidin plasma levels. [ Time Frame: 6 months ]
  4. Changes on erythropoietin plasma levels. [ Time Frame: 6 months ]
  5. Changes on systolic blood pressure. [ Time Frame: 6 months ]
    Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.

  6. Changes on diastolic blood pressure. [ Time Frame: 6 months ]
    Changes in mmHg determined by 24 hours ambulatory blood pressure monitoring.

  7. Cardiovascular serious adverse events in each arm of treatment. [ Time Frame: 6 months ]
    Cardiac arrest, angina pectoris. Stroke.

  8. Adverse events related to vascular access disfunction. [ Time Frame: 6 month ]
    Arteriovenous fistula site hemorrhage or thrombosis. Catheter disfunction.



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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT02876211


Contacts
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Contact: Miguel Uriol, Ph.D.M.D. 00-34-871-205000 ext 75212 miguelg.uriol@ssib.es

Locations
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Spain
Son Espases University Hospital Recruiting
Palma de Mallorca, Islas Baleares, Spain, 07120
Contact: Miguel Uriol, Ph.D.M.D.    00-34-871205000 ext 75212    miguelg.uriol@ssib.es   
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.         
Sponsors and Collaborators
Hospital Son Espases
Investigators
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Principal Investigator: Miguel Uriol, Ph.D.M.D. Son Espases University Hospital

Publications:
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Responsible Party: Miguel Giovanni Uriol Rivera, Ph.D. MD., Hospital Son Espases
ClinicalTrials.gov Identifier: NCT02876211     History of Changes
Other Study ID Numbers: PIERAID-2013
First Posted: August 23, 2016    Key Record Dates
Last Update Posted: September 17, 2018
Last Verified: September 2018
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Keywords provided by Miguel Giovanni Uriol Rivera, Hospital Son Espases:
Renal disease
Erythropoiesis
Erythropoietin stimulating agent
Iron
Klotho
Selective vitamin D receptor activation
Additional relevant MeSH terms:
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Anemia
Inflammation
Pathologic Processes
Hematologic Diseases
Vitamin D
Ergocalciferols
Vitamins
Epoetin Alfa
Micronutrients
Nutrients
Growth Substances
Physiological Effects of Drugs
Bone Density Conservation Agents
Calcium-Regulating Hormones and Agents
Hematinics