Effect of Paricalcitol vs Calcitriol on Hemoglobin Levels in Chronic Kidney Disease Patients: A Randomized Trial
Publication Date
March 17, 2015
Journal
PLOS ONE
Authors
Eleonora Riccio, Massimo Sabbatini, Dario Bruzzese, Ivana Capuano, et al
Volume
10
Issue
3
Pages
e0118174
DOI
https://dx.plos.org/10.1371/journal.pone.0118174
Publisher URL
http://journals.plos.org/plosone/article?id=10.1371%2Fjournal.pone.0118174
PubMed
http://www.ncbi.nlm.nih.gov/pubmed/25781618
PubMed Central
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC4363688
Europe PMC
http://europepmc.org/abstract/MED/25781618
Web of Science
000351284600021
Scopus
84924956343
Mendeley
http://www.mendeley.com/research/effect-paricalcitol-vs-calcitriol-hemoglobin-levels-chronic-kidney-disease-patients-randomized-trial-2
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Mendeley 1127 Apr 22:32 UTC

Mendeley | Further Information

{"title"=>"Effect of paricalcitol vs calcitriol on hemoglobin levels in chronic kidney disease patients: A randomized trial", "type"=>"journal", "authors"=>[{"first_name"=>"Eleonora", "last_name"=>"Riccio", "scopus_author_id"=>"20436399100"}, {"first_name"=>"Massimo", "last_name"=>"Sabbatini", "scopus_author_id"=>"26027207000"}, {"first_name"=>"Dario", "last_name"=>"Bruzzese", "scopus_author_id"=>"6602597648"}, {"first_name"=>"Ivana", "last_name"=>"Capuano", "scopus_author_id"=>"55832762400"}, {"first_name"=>"Silvia", "last_name"=>"Migliaccio", "scopus_author_id"=>"7003603251"}, {"first_name"=>"Michele", "last_name"=>"Andreucci", "scopus_author_id"=>"6701409316"}, {"first_name"=>"Antonio", "last_name"=>"Pisani", "scopus_author_id"=>"7006447950"}], "year"=>2015, "source"=>"PLoS ONE", "identifiers"=>{"pui"=>"603051714", "sgr"=>"84924956343", "pmid"=>"25781618", "scopus"=>"2-s2.0-84924956343", "doi"=>"10.1371/journal.pone.0118174", "issn"=>"19326203"}, "id"=>"bd105a63-06fe-36e8-b7b2-1e49577b7fbc", "abstract"=>"BACKGROUND Recent studies suggest that vitamin D deficiency represents an additional cofactor of renal anemia, with several mechanisms accounting for this relationship. In line with it, the administration of vitamin D or its analogues has been associated with an improvement of anemia. There are no data, however, about a direct effect of paricalcitol on hemoglobin (Hb) levels. Therefore, we conducted a study to determine whether paricalcitol, compared to calcitriol, improves anemia in patients with chronic kidney disease (CKD). METHODS In this randomized trial 60 CKD patients stage 3b-5 and anemia (Hb levels: 10-12.5 g/dL) were assigned (1:1) to receive low doses of calcitriol (Group Calcitriol) or paricalcitol (Group Paricalcitol) for 6 months. All the patients had normal values of plasma calcium, phosphorus and PTH, a stable iron balance, and normal values of C-Reactive Protein. The primary endpoint was to evaluate the effects of the two treatments on Hb levels; the modifications in 24hr-proteinuria (UProt) were also evaluated. RESULTS A significant Group x Time interaction effect was observed in the longitudinal analysis of Hb levels (F(1,172)=31.4, p<0.001). Subjects in Paricalcitol experienced a significant monthly increase of Hb levels equal to +0.16 g/dL [95% C.I. 0.10 to +0.22, p<0.001) while in Group Calcitriol, Hb decrease throughout the follow-up with an average monthly rate of -0.10 g/dL (95% C.I.: -0.17 to -0.04, p<0.001). In Group Paricalcitol, UProt was significantly reduced after 6 months [0.35 (0.1-1.2) vs 0.59 (0.2-1.6), p<0.01], whereas no significant difference emerged in Group Calcitriol. Plasma levels of calcium, phosphate, PTH and of inflammation markers remained in the normal range in both groups throughout the study. CONCLUSIONS Short-term exposure to paricalcitol results in an independent increase in Hb levels, which occurred with no modification of iron balance, inflammatory markers, and PTH plasma concentrations, and was associated with a decrease in UProt. TRIAL REGISTRATION ClinicalTrials.gov NCT01768351.", "link"=>"http://www.mendeley.com/research/effect-paricalcitol-vs-calcitriol-hemoglobin-levels-chronic-kidney-disease-patients-randomized-trial-2", "reader_count"=>11, "reader_count_by_academic_status"=>{"Unspecified"=>1, "Researcher"=>4, "Student > Ph. D. Student"=>2, "Student > Master"=>3, "Student > Bachelor"=>1}, "reader_count_by_user_role"=>{"Unspecified"=>1, "Researcher"=>4, "Student > Ph. D. Student"=>2, "Student > Master"=>3, "Student > Bachelor"=>1}, "reader_count_by_subject_area"=>{"Unspecified"=>1, "Biochemistry, Genetics and Molecular Biology"=>1, "Agricultural and Biological Sciences"=>1, "Medicine and Dentistry"=>6, "Pharmacology, Toxicology and Pharmaceutical Science"=>2}, "reader_count_by_subdiscipline"=>{"Medicine and Dentistry"=>{"Medicine and Dentistry"=>6}, "Agricultural and Biological Sciences"=>{"Agricultural and Biological Sciences"=>1}, "Biochemistry, Genetics and Molecular Biology"=>{"Biochemistry, Genetics and Molecular Biology"=>1}, "Unspecified"=>{"Unspecified"=>1}, "Pharmacology, Toxicology and Pharmaceutical Science"=>{"Pharmacology, Toxicology and Pharmaceutical Science"=>2}}, "reader_count_by_country"=>{"Spain"=>1}, "group_count"=>0}
Scopus 1829 Nov 20:09 UTC

Scopus | Further Information

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Figshare 4115 Apr 04:34 UTC

Figshare

  • {"files"=>["https://ndownloader.figshare.com/files/1953966"], "description"=>"<p>Data are expressed as means ± SD or as median and interquartile range.</p><p>* = p<0.05, minimum value, vs baseline T0;</p><p># = p<0.05, minimum value, difference between groups (same period).</p><p>Abbreviations and measure units: Hb, Hemoglobin (g/dl); GFR, glomerular filtration rate (ml/min); Ferritin (ng/dl); TSAT, transferrin saturation (%); Ca, calcium plasma levels (mg/dl); P, phosphate plasma levels (mg/dl); PTH, parathormon (ng/ml); hsCRP, high sensitivity C reactive protein (mg/dl); UProt, 24 hours urinary protein excretion (g/day); SBP and DBP, systolic and diastolic blood pressure, respectively (mm Hg).</p><p>T0: baseline; T2, T4, and T6: 2, 4, and 6 months of follow-up.</p><p>Main clinical and laboratory data in the two Groups under study throughout the follow-up period (n = 30 in both groups).</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339742, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.t003", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Main_clinical_and_laboratory_data_in_the_two_Groups_under_study_throughout_the_follow_up_period_n_30_in_both_groups_/1339742", "title"=>"Main clinical and laboratory data in the two Groups under study throughout the follow-up period (n = 30 in both groups).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953963"], "description"=>"<p>Data are expressed as means ± SE. Abbreviations: T0, baseline levels; T2, T4 and T6, values after 2, 4 and 6 months of follow-up with both drugs.</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339739, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.g003", "stats"=>{"downloads"=>0, "page_views"=>5, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effects_of_calcitriol_Group_Calcitriol_dashed_lines_and_paricalcitol_Group_Paricalcitol_solid_lines_on_urinary_protein_excretion_GFR_ratio_throughout_the_study_/1339739", "title"=>"Effects of calcitriol (Group Calcitriol, dashed lines) and paricalcitol (Group Paricalcitol, solid lines) on urinary protein excretion/GFR ratio throughout the study.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953962"], "description"=>"<p>Data are expressed as means ± SD. Abbreviations: T0, baseline levels; T2, T4 and T6, values after 2, 4 and 6 months of follow-up with both drugs. * = p<0.05 (minimum value) vs T0; § = p<0.05 (minimum value) vs respective period of Group CALC</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339738, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.g002", "stats"=>{"downloads"=>0, "page_views"=>3, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effects_of_calcitriol_Group_Calcitriol_dashed_lines_and_paricalcitol_Group_Paricalcitol_solid_lines_on_hemoglobin_plasma_levels_throughout_the_study_/1339738", "title"=>"Effects of calcitriol (Group Calcitriol, dashed lines) and paricalcitol (Group Paricalcitol, solid lines) on hemoglobin plasma levels throughout the study.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953965"], "description"=>"<p>Data are expressed as means ± standard deviation or as median and interquartile range.</p><p>Main laboratory data of the patients under study (ALL, N = 60), and in the two groups after randomization (n = 30 in both groups).</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339741, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.t002", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Main_laboratory_data_of_the_patients_under_study_ALL_N_60_and_in_the_two_groups_after_randomization_n_30_in_both_groups_/1339741", "title"=>"Main laboratory data of the patients under study (ALL, N = 60), and in the two groups after randomization (n = 30 in both groups).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953964"], "description"=>"<p>Data are expressed as means ± SD; data in brackets express the % values in that group.</p><p>° p<0.05 between groups</p><p>Abbreviations: eGFR, estimated glomerular filtration rate; CKD, chronic kidney disease; GN, glomerulonephritis; DM: diabetes mellitus; ADPKD, adult polycystic kidney disease; ACE-I, inhibitors of angiotensin converting enzyme; ARB, angiotensin receptor blockers; ESA, erythropoiesis stimulating agents.</p><p>Primary kidney disease was classified according to the European Renal Association codes.</p><p>Demographic characteristics, diagnosis of renal disease and drug treatments in the 2 groups under study (n = 30 each).</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339740, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.t001", "stats"=>{"downloads"=>0, "page_views"=>2, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Demographic_characteristics_diagnosis_of_renal_disease_and_drug_treatments_in_the_2_groups_under_study_n_30_each_/1339740", "title"=>"Demographic characteristics, diagnosis of renal disease and drug treatments in the 2 groups under study (n = 30 each).", "pos_in_sequence"=>0, "defined_type"=>3, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953961"], "description"=>"<p>Flow chart of patient selection.</p>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339737, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>"https://dx.doi.org/10.1371/journal.pone.0118174.g001", "stats"=>{"downloads"=>0, "page_views"=>12, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Flow_chart_of_patient_selection_/1339737", "title"=>"Flow chart of patient selection.", "pos_in_sequence"=>0, "defined_type"=>1, "published_date"=>"2015-03-17 06:32:28"}
  • {"files"=>["https://ndownloader.figshare.com/files/1953967", "https://ndownloader.figshare.com/files/1953968"], "description"=>"<div><p>Background</p><p>Recent studies suggest that vitamin D deficiency represents an additional cofactor of renal anemia, with several mechanisms accounting for this relationship. In line with it, the administration of vitamin D or its analogues has been associated with an improvement of anemia. There are no data, however, about a direct effect of paricalcitol on hemoglobin (Hb) levels. Therefore, we conducted a study to determine whether paricalcitol, compared to calcitriol, improves anemia in patients with chronic kidney disease (CKD).</p><p>Methods</p><p>In this randomized trial 60 CKD patients stage 3b-5 and anemia (Hb levels: 10-12.5 g/dL) were assigned (1:1) to receive low doses of calcitriol (Group Calcitriol) or paricalcitol (Group Paricalcitol) for 6 months. All the patients had normal values of plasma calcium, phosphorus and PTH, a stable iron balance, and normal values of C-Reactive Protein. The primary endpoint was to evaluate the effects of the two treatments on Hb levels; the modifications in 24hr-proteinuria (UProt) were also evaluated.</p><p>Results</p><p>A significant Group x Time interaction effect was observed in the longitudinal analysis of Hb levels (F(1,172)=31.4, p<0.001). Subjects in Paricalcitol experienced a significant monthly increase of Hb levels equal to +0.16 g/dL [95% C.I. 0.10 to +0.22, p<0.001) while in Group Calcitriol, Hb decrease throughout the follow-up with an average monthly rate of -0.10 g/dL (95% C.I.: -0.17 to -0.04, p<0.001). In Group Paricalcitol, UProt was significantly reduced after 6 months [0.35 (0.1-1.2) vs 0.59 (0.2-1.6), p<0.01], whereas no significant difference emerged in Group Calcitriol. Plasma levels of calcium, phosphate, PTH and of inflammation markers remained in the normal range in both groups throughout the study.</p><p>Conclusions</p><p>Short-term exposure to paricalcitol results in an independent increase in Hb levels, which occurred with no modification of iron balance, inflammatory markers, and PTH plasma concentrations, and was associated with a decrease in UProt.</p><p>Trial Registration</p><p>ClinicalTrials.gov <a href=\"https://clinicaltrials.gov/ct2/show/NCT01768351\" target=\"_blank\">NCT01768351</a></p></div>", "links"=>[], "tags"=>["anemia", "randomized trial 60 CKD patients stage 3 b", "Vitamin D deficiency", "Paricalcitol vs Calcitriol", "iron balance", "Group Paricalcitol", "Randomized Trial BackgroundRecent studies", "Hb levels", "Chronic Kidney Disease Patients", "paricalcitol", "C.I", "nct", "PTH plasma concentrations", "Group x Time interaction effect", "Group Calcitriol"], "article_id"=>1339743, "categories"=>["Biological Sciences"], "users"=>["Eleonora Riccio", "Massimo Sabbatini", "Dario Bruzzese", "Ivana Capuano", "Silvia Migliaccio", "Michele Andreucci", "Antonio Pisani"], "doi"=>["https://dx.doi.org/10.1371/journal.pone.0118174.s001", "https://dx.doi.org/10.1371/journal.pone.0118174.s002"], "stats"=>{"downloads"=>6, "page_views"=>8, "likes"=>0}, "figshare_url"=>"https://figshare.com/articles/_Effect_of_Paricalcitol_vs_Calcitriol_on_Hemoglobin_Levels_in_Chronic_Kidney_Disease_Patients_A_Randomized_Trial_/1339743", "title"=>"Effect of Paricalcitol vs Calcitriol on Hemoglobin Levels in Chronic Kidney Disease Patients: A Randomized Trial", "pos_in_sequence"=>0, "defined_type"=>4, "published_date"=>"2015-03-17 06:32:28"}
PMC Usage Stats 153617 Nov 21:25 UTC

PMC Usage Stats | Further Information

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Relative Metric10 May 17:59 UTC

Relative Metric

{"start_date"=>"2015-01-01T00:00:00Z", "end_date"=>"2015-12-31T00:00:00Z", "subject_areas"=>[]}
F1000Prime 111 Dec 12:56 UTC

F1000Prime | Further Information

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