Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
TERMINATED
PHASE4
19 participants
INTERVENTIONAL
2014-12-31
2024-12-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
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.
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Keywords
Explore important study keywords that can help with search, categorization, and topic discovery.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
paricalcitol plus epoetin beta
Paricalcitol 2 capsules /three times per week \& epoetin
Paricalcitol
Paricalcitol 2 capsules/three times per week
Epoetin beta
epoetin 1-3 times per week
placebo plus epoetin beta
Placebo 2 capsules/three times per week \& epoetin
Epoetin beta
epoetin 1-3 times per week
Placebo
Placebo 2 capsules/three times per week
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Paricalcitol
Paricalcitol 2 capsules/three times per week
Epoetin beta
epoetin 1-3 times per week
Placebo
Placebo 2 capsules/three times per week
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
* 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
* 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.
18 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Hospital Son Espases
OTHER
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Miguel Giovanni Uriol Rivera
Ph.D. MD.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Miguel Uriol, Ph.D.M.D.
Role: PRINCIPAL_INVESTIGATOR
Son Espases University Hospital
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Son Espases University Hospital
Palma de Mallorca, Balearic Islands, Spain
Countries
Review the countries where the study has at least one active or historical site.
References
Explore related publications, articles, or registry entries linked to this study.
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.
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.
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.
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
PIERAID-2013
Identifier Type: -
Identifier Source: org_study_id